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2026 data FDA MAUDE openFDA FDA Class I

Counter, Sponge, Surgical

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

OpenFDA device adverse-event casebook.

FDA Class I (lowest regulatory risk tier, general controls), regulated under 21 CFR §880.2740 (General Hospital panel).

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FDA MAUDE casebook

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

#843 of 1000 · 579 reports · 1997–2026

  • BOOK 579 reports
  • RANK #843 of 1000
  • DEATH 0 death-typed
  • INJ 88 injury-typed
  • MALF 484 malfunction
  • SPAN 1997–2026
  • PEAK 2017: 107
  • PHOTO Applier

Nearest event-volume peer: Applier, Staple, Surgical, (1 report gap)

Counter, Sponge, Surgical sits #843 of 1000 among tracked device types with 579 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 →

Malfunction reports run above the device-type norm

Counter, Sponge, Surgical carries 83.6% MALFUNCTION-coded reports, 18.8pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 0.0% corpus 1.5% · below corpus mean (-1.5 pp)
  • INJ 15.2% corpus 30.3% · below corpus mean (-15.1 pp)
  • MALF 83.6% corpus 64.8% · above corpus mean (+18.8 pp)

Lead product-problem code False Positive Result is 56% of coded problems · Lead manufacturer COVIDIEN MFG DC BOULDER accounts for 74% of manufacturer-tagged reports · Top event location I is 54% of location-tagged rows .

Counter, Sponge, Surgical in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Counter, Sponge, Surgical carries 579 MAUDE reports, ranked #843 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Malfunction 484 (83.6%)
Injury 88 (15.2%)
6 (1.0%)
Other 1 (0.2%)

Patient Outcomes

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

475 (79.4%)
Required Intervention 49 (8.2%)
Other 38 (6.4%)
R 14 (2.3%)
Hospitalization 8 (1.3%)
O 5 (0.8%)
H 4 (0.7%)
L 2 (0.3%)
Disability 2 (0.3%)
Life Threatening 1 (0.2%)

Top Product Problems

False Positive Result 323
False Negative Result 132
Device Displays Incorrect Message 23
Adverse Event Without Identified Device or Use Problem 11
Device Operates Differently Than Expected 7
Improper or Incorrect Procedure or Method 7
Insufficient Device Problem Information 7
Material Integrity Problem 7
Component Missing 6
Material Frayed 6
Failure to Sense 5
Material Fragmentation 5
Packaging Problem 5
Particulates 5
Break 4
Computer Software Problem 4
Defective Device 4
High Readings 4
Incomplete or Missing Packaging 4
Loose or Intermittent Connection 4

Yearly Trend

97
1997: 1
06
2006: 3
07
2007: 1
08
2008: 1
09
2009: 2
10
2010: 3
11
2011: 14
12
2012: 6
13
2013: 5
14
2014: 16
15
2015: 8
16
2016: 40
17
2017: 107
18
2018: 64
19
2019: 66
20
2020: 33
21
2021: 35
22
2022: 41
23
2023: 39
24
2024: 37
25
2025: 35
26
2026: 22

Reports in 2025 (35) held close to the prior two-year average of 38.

Related Entities for Counter, Sponge, Surgical

Top Manufacturers

COVIDIEN MFG DC BOULDER 156
COVIDIEN 36
STRYKER INSTRUMENTS-A DIVISION OF STRYKER CORP 13
MEDTRONIC, INC. 7

Event Locations

I 315 (54.4%)
198 (34.2%)
HOSPITAL 55 (9.5%)
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 a comparable report-volume footprint

Counter, Sponge, Surgical carries zero death-typed MAUDE reports, so the peer set below compares report volume only; both axes are floored at ≥100 reports so the neighborhood stays in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (579 here).

Applier, Staple, Surgical, 580 Drug-Eluting Percutaneous Transluminal Coro… 578 Microspheres Radionuclide 578 Blood/Plasma Collection Device For Dna Test… 581

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.