What are FDA adverse event reports for Insufflator, Laparoscopic?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Insufflator, Laparoscopic, there are 6,632 total reports including 34 death reports and 791 injury reports. These reports are submitted by manufacturers, healthcare facilities, and patients. A high number of reports does not necessarily mean a device is unsafe, widely used devices naturally generate more reports.

How should I interpret MAUDE data for Insufflator, Laparoscopic?

MAUDE reports are raw adverse event submissions, not confirmed safety findings. A report that a device was involved in a death does not mean the device caused the death. Reports vary in quality and completeness. The FDA uses MAUDE data as one input among many in its safety surveillance, it does not draw conclusions from individual reports. Always consult your healthcare provider about device safety questions.

2026 data FDA MAUDE openFDA

Insufflator, Laparoscopic

Name: Insufflator, Laparoscopic - FDA MAUDE Adverse Event Reports
Creator: PlainHospital
License: https://creativecommons.org/publicdomain/zero/1.0/

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

Compiled by PlainHospital · August 14, 2026

OpenFDA device adverse-event casebook.

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FDA MAUDE casebook

openFDA event book Insufflator, Laparoscopic LIGHT-BOOK · MAUDE

#267 of 1000 · 6,632 reports · 1992–2026

BOOK 6,632 reports
RANK #267 of 1000
DEATH 34 death-typed
INJ 791 injury-typed
MALF 5,763 malfunction
SPAN 1992–2026
PEAK 2025: 1,519
PHOTO Container, I.V.

Nearest event-volume peer: Container, I.V. (2 report gap)

Insufflator, Laparoscopic sits #267 of 1000 among tracked device types with 6,632 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

DEATH 0.5% corpus 1.5% · below corpus mean (-1.0 pp)
INJ 11.9% corpus 30.4% · below corpus mean (-18.5 pp)
MALF 86.9% corpus 64.5% · above corpus mean (+22.4 pp)

Lead product-problem code Pressure Problem is 12% of coded problems · Lead manufacturer SHIRAKAWA OLYMPUS CO., LTD. accounts for 71% of manufacturer-tagged reports · Top event location is 80% of location-tagged rows .

Device

6,722
Insufflator (this)

6,632
Container

6,630
Toothbrush

6,625
Prosthesis

6,593
Continuous

6,546

What this shows Insufflator, Laparoscopic carries 6,632 MAUDE reports, ranked #267 of 1000.

Event Types

Malfunction 5,763 (86.9%)

Injury 791 (11.9%)

Other 35 (0.5%)

Death 34 (0.5%)

9 (0.1%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

5,707 (84.3%)

Other 631 (9.3%)

Required Intervention 118 (1.7%)

Hospitalization 85 (1.3%)

R 61 (0.9%)

O 42 (0.6%)

Life Threatening 37 (0.5%)

Death 32 (0.5%)

H 26 (0.4%)

L 12 (0.2%)

D 7 (0.1%)

S 6 (0.1%)

Disability 3 (0.0%)

Congenital Anomaly 1 (0.0%)

Yearly Trend

1992: 4

1993: 7

1994: 1

1995: 1

1996: 1

1997: 3

1998: 9

1999: 7

2000: 4

2001: 6

2002: 5

2003: 11

2004: 9

2005: 9

2006: 12

2007: 8

2008: 14

2009: 21

2010: 41

2011: 44

2012: 38

2013: 40

2014: 43

2015: 30

2016: 72

2017: 68

2018: 97

2019: 128

2020: 360

2021: 654

2022: 667

2023: 890

2024: 1,483

2025: 1,519

2026: 326

Top Manufacturers

SHIRAKAWA OLYMPUS CO., LTD. 4,005

OLYMPUS MEDICAL SYSTEMS CORP. 1,173

STRYKER ENDOSCOPY-SAN JOSE 312

STRYKER ENDOSCOPY SAN JOSE 61

KARL STORZ SE & CO. KG 37

ETHICON ENDO-SURGERY, LLC. 32

Event Locations

5,323 (80.3%)

I 1,080 (16.3%)

HOSPITAL 202 (3.0%)

NO INFORMATION 13 (0.2%)

OTHER 6 (0.1%)

INVALID DATA 3 (0.0%)

AMBULATORY SURGICAL FACILITY 2 (0.0%)

HOME 2 (0.0%)

UNKNOWN 1 (0.0%)

Compare SHIRAKAWA OLYMPUS CO., LTD. vs OLYMPUS MEDICAL SYSTEMS CORP. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Insufflator, Laparoscopic, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (6,632 here).

Container, I.V. 6,630 Toothbrush, Powered 6,625 Prosthesis 6,593 Continuous, Ventilator, Home Use 6,546

Similar death-typed counts

Nearest other device types by death-typed report count (34 here), distinct from the volume row.

Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 34 Mattress, Flotation Therapy, Non-Powered 34 Prosthesis 34 Ventilator, Emergency, Powered 34

Read our methodology - how this data is sourced, computed, and verified.

Disclaimer: MAUDE figures for Insufflator, Laparoscopic are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Insufflator, Laparoscopic; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.

Insufflator, Laparoscopic

Event-type mix vs corpus