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
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 ↗
Other Hysteroscope Accessories devices
- Olympus A4825OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories8 reports
- Olympus A4829OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories8 reports
- OMNI OMNI-S-001Hologic, Inc. · Hysteroscope accessories8 reports
- CLICKLINE 26312Karl Storz GmbH & Co. KG · Hysteroscope accessories6 reports
- n.a. 26153BIKarl Storz GmbH & Co. KG · Hysteroscope accessories3 reports
- Olympus A4827OLYMPUS Winter & Ibe GmbH · Hysteroscope Accessories1 report
- NA M006550340Boston Scientific Corporation · Hysteroscope accessories1 report
- OMNI OMNI-G-001Hologic, Inc. · Hysteroscope accessories1 report
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page