What are FDA adverse event reports for Insufflator, Hysteroscopic?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Insufflator, Hysteroscopic, there are 523 total reports including 12 death reports and 79 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, Hysteroscopic?

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, Hysteroscopic

Name: Insufflator, Hysteroscopic - 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, Hysteroscopic LIGHT-BOOK · MAUDE

#854 of 1000 · 523 reports · 1992–2026

BOOK 523 reports
RANK #854 of 1000
DEATH 12 death-typed
INJ 79 injury-typed
MALF 425 malfunction
SPAN 1992–2026
PEAK 2021: 130
PHOTO Table, Obstetric

Nearest event-volume peer: Table, Obstetric (And Accessories) (0 report gap)

Insufflator, Hysteroscopic sits #854 of 1000 among tracked device types with 523 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 2.3% corpus 1.5% · above corpus mean (+0.8 pp)
INJ 15.1% corpus 30.4% · below corpus mean (-15.3 pp)
MALF 81.3% corpus 64.5% · above corpus mean (+16.8 pp)

Lead product-problem code Material Fragmentation is 36% of coded problems · Lead manufacturer HOLOGIC, INC. accounts for 62% of manufacturer-tagged reports · Top event location I is 38% of location-tagged rows .

Snare

527
Kit

526
Insufflator (this)

523
Table

523
Unit

521
Percutaneousl…

519

What this shows Insufflator, Hysteroscopic carries 523 MAUDE reports, ranked #854 of 1000.

Event Types

Malfunction 425 (81.3%)

Injury 79 (15.1%)

Death 12 (2.3%)

Other 6 (1.1%)

1 (0.2%)

Patient Outcomes

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

395 (69.8%)

Other 61 (10.8%)

Hospitalization 37 (6.5%)

R 19 (3.4%)

O 13 (2.3%)

Death 12 (2.1%)

Required Intervention 12 (2.1%)

L 8 (1.4%)

Life Threatening 6 (1.1%)

H 3 (0.5%)

Yearly Trend

1992: 1

1993: 1

1994: 1

1997: 2

1999: 7

2000: 6

2001: 2

2002: 2

2003: 5

2005: 1

2006: 6

2008: 2

2009: 3

2010: 1

2011: 4

2012: 4

2013: 5

2014: 9

2015: 10

2016: 10

2017: 11

2018: 10

2019: 66

2020: 31

2021: 130

2022: 66

2023: 33

2024: 45

2025: 46

2026: 3

Top Manufacturers

HOLOGIC, INC. 209

HOLOGIC, INC 38

STRYKER ENDOSCOPY-SAN JOSE 34

KARL STORZ SE & CO. KG 26

SMITH & NEPHEW, INC. 20

COVIDIEN 8

Event Locations

I 200 (38.2%)

189 (36.1%)

HOSPITAL 115 (22.0%)

AMBULATORY SURGICAL FACILITY 7 (1.3%)

NO INFORMATION 6 (1.1%)

OUTPATIENT TREATMENT FACILITY 3 (0.6%)

HOME 1 (0.2%)

INVALID DATA 1 (0.2%)

OTHER 1 (0.2%)

Compare HOLOGIC, INC. vs HOLOGIC, INC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Insufflator, Hysteroscopic, 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 (523 here).

Table, Obstetric 523 Unit, X-Ray, Extraoral With Timer 521 Kit, Surgical Instrument, Disposable 526 Percutaneously Delivered Prostheses And Tri… 519

Similar death-typed counts

Nearest other device types by death-typed report count (12 here), distinct from the volume row.

Adhesive 12 Blood Pump For Ecmo, Long-Term Use 12 Catheter, Retention Type, Balloon 12 Digital Breast Tomosynthesis 12

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

Disclaimer: MAUDE figures for Insufflator, Hysteroscopic 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, Hysteroscopic; 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, Hysteroscopic

Event-type mix vs corpus