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Olympus A4832Recalls & reported problems

OLYMPUS Winter & Ibe GmbH · Class 1

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
12
Deaths reported
0
Injuries reported
10
Recalls naming it
0

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 04042761006958), received between Sep 3, 2025 and Jan 28, 2026 — classified as 10 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (11 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Reports received per month

Nov 2023: 0 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 0 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 0 reportsMay 2025: 0 reportsJun 2025: 0 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 1 reportsDec 2025: 5 reportsJan 2026: 5 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Break11
  • Detachment of Device or Device Component9
  • Difficult to Open or Close1

Patient problems

  • No Clinical Signs, Symptoms or Conditions12

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

  • InjuryJan 28, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THE BIOPSY FORCEPS WAS DAMAGED DUE TO THE FRACTURE OF THE HEAD LOCKING PIN OF THE BIOPSY FORCEPS HEAD DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 1 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201167 ↗
  • InjuryJan 28, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THE BIOPSY FORCEPS WAS DAMAGED DUE TO THE FRACTURE OF THE HEAD LOCKING PIN OF THE BIOPSY FORCEPS HEAD DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 3 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201150 ↗
  • InjuryJan 28, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THE BIOPSY FORCEPS WAS DAMAGED DUE TO THE FRACTURE OF THE HEAD LOCKING PIN OF THE BIOPSY FORCEPS HEAD DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 4 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201135 ↗
  • InjuryJan 28, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THE BIOPSY FORCEPS WAS DAMAGED DUE TO THE FRACTURE OF THE HEAD LOCKING PIN OF THE BIOPSY FORCEPS HEAD DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 2 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201098 ↗
  • InjuryJan 28, 2026Break; Detachment of Device or Device Component

    IT WAS REPORTED THE BIOPSY FORCEPS WAS DAMAGED DUE TO THE FRACTURE OF THE HEAD LOCKING PIN OF THE BIOPSY FORCEPS HEAD DURING AN UNSPECIFIED SURGICAL PROCEDURE. THE PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THIS IS REPORT 5 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 24201064 ↗
  • InjuryDec 19, 2025Break; Break

    IT WAS REPORTED THAT FIVE BIOPSY FORCEPS WERE DAMAGED ALL DUE TO THE FRACTURE OF THE FIXING PINS OF THE FORCEPS HEAD DURING AN UNSPECIFIED PROCEDURE. THE FIXING PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER IS CURRENTLY PENDING. THIS IS REPORT 1 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23852477 ↗
  • InjuryDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT FIVE BIOPSY FORCEPS WERE DAMAGED ALL DUE TO THE FRACTURE OF THE FIXING PINS OF THE FORCEPS HEAD DURING AN UNSPECIFIED PROCEDURE. THE FIXING PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER IS CURRENTLY PENDING. THIS IS REPORT 2 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23852452 ↗
  • InjuryDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT FIVE BIOPSY FORCEPS WERE DAMAGED ALL DUE TO THE FRACTURE OF THE FIXING PINS OF THE FORCEPS HEAD DURING AN UNSPECIFIED PROCEDURE. THE FIXING PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER IS CURRENTLY PENDING. THIS IS REPORT 3 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23852077 ↗
  • InjuryDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    NO ADDITIONAL INFORMATION WAS RECEIVED FROM THE CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23852042 ↗
  • InjuryDec 19, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

    IT WAS REPORTED THAT FIVE BIOPSY FORCEPS WERE DAMAGED ALL DUE TO THE FRACTURE OF THE FIXING PINS OF THE FORCEPS HEAD DURING AN UNSPECIFIED PROCEDURE. THE FIXING PIN OF THE FORCEPS HEAD FELL INTO THE PATIENT'S UTERINE CAVITY. THE FALLEN PART WAS RETRIEVED. THERE WERE NO REPORTS OF PATIENT HARM. THE REQUESTED ADDITIONAL INFORMATION FROM THE CUSTOMER IS CURRENTLY PENDING. THIS IS REPORT 5 OF 5.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23851958 ↗
  • MalfunctionNov 11, 2025Difficult to Open or Close; Difficult to Open or Close

    IT WAS OBSERVED THAT DURING THE DEVICE EVALUATION, THE SUBJECT DEVICE EXHIBITED THE HANDLE THAT COULD NOT CONTROL THE OPENING AND CLOSING OF THE FORCEPS, DEFORMED JOINT AT THE CONNECTION POINT OF FORCEPS PORT (JAWS), THE PIN IS MISSING AND COMPONENT FAILURE OF THE FORCEPS PORT (JAWS). THERE WAS NO PATIENT INVOLVEMENT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23524489 ↗
  • MalfunctionSep 3, 2025Break; Break

    NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22952995 ↗

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Sources and updates

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