What are FDA adverse event reports for Counter, Sponge, Surgical?

The FDA's MAUDE (Manufacturer and User Facility Device Experience) database collects reports of adverse events involving medical devices. For Counter, Sponge, Surgical, there are 560 total reports including 0 death reports and 83 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 Counter, Sponge, Surgical?

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

Counter, Sponge, Surgical

Name: Counter, Sponge, Surgical - 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.

Browse devices → Device safety hub

FDA MAUDE casebook

openFDA event book Counter, Sponge, Surgical LIGHT-BOOK · MAUDE

#834 of 1000 · 560 reports · 1997–2026

BOOK 560 reports
RANK #834 of 1000
DEATH 0 death-typed
INJ 83 injury-typed
MALF 470 malfunction
SPAN 1997–2026
PEAK 2017: 107
PHOTO Device

Nearest event-volume peer: Device, Urine Flow Rate Measuring, Non-Electrical, Disposable (2 report gap)

Counter, Sponge, Surgical sits #834 of 1000 among tracked device types with 560 MAUDE reports spanning 1997–2026. 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 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
INJ 14.8% corpus 30.4% · below corpus mean (-15.6 pp)
MALF 83.9% corpus 64.5% · above corpus mean (+19.4 pp)

Lead product-problem code False Positive Result is 60% of coded problems · Lead manufacturer COVIDIEN MFG DC BOULDER accounts for 80% of manufacturer-tagged reports · Top event location I is 56% of location-tagged rows .

Device

568
Chair

564
Injector

564
Microspheres…

562
Counter (this)

560
Device

558

What this shows Counter, Sponge, Surgical carries 560 MAUDE reports, ranked #834 of 1000.

Event Types

Malfunction 470 (83.9%)

Injury 83 (14.8%)

6 (1.1%)

Other 1 (0.2%)

Patient Outcomes

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

464 (79.3%)

Required Intervention 49 (8.4%)

Other 36 (6.2%)

R 14 (2.4%)

Hospitalization 8 (1.4%)

O 5 (0.9%)

H 4 (0.7%)

L 2 (0.3%)

Disability 2 (0.3%)

Life Threatening 1 (0.2%)

Yearly Trend

1997: 1

2006: 3

2007: 1

2008: 1

2009: 2

2010: 3

2011: 14

2012: 6

2013: 5

2014: 16

2015: 8

2016: 40

2017: 107

2018: 64

2019: 66

2020: 33

2021: 35

2022: 41

2023: 39

2024: 37

2025: 35

2026: 3

Top Manufacturers

COVIDIEN MFG DC BOULDER 156

COVIDIEN 22

STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 12

MEDTRONIC, INC. 6

Event Locations

I 315 (56.3%)

179 (32.0%)

HOSPITAL 55 (9.8%)

NO INFORMATION 8 (1.4%)

INVALID DATA 1 (0.2%)

OPERATING ROOM 1 (0.2%)

OTHER 1 (0.2%)

Compare COVIDIEN MFG DC BOULDER vs COVIDIEN →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Counter, Sponge, Surgical, 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 (560 here).

Device 558 Microspheres Radionuclide 562 Chair, Adjustable, Mechanical 564 Injector, Contrast Medium, Automatic 564

Similar death-typed counts

Nearest other device types by death-typed report count (0 here), distinct from the volume row.

Aberrometer, Ophthalmic 0 Accessories, Arthroscopic 0 Accessories, Cleaning Brushes, For Endoscope 0 Accessories, Implant, Dental, Endosseous 0

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

Disclaimer: MAUDE figures for Counter, Sponge, Surgical 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 Counter, Sponge, Surgical; 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.

Counter, Sponge, Surgical

Event-type mix vs corpus