Olympus A2499Recalls & reported problems
OLYMPUS Winter & Ibe GmbH · Biopsy forceps, 5 Fr., semi-flexible · Class 2
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04042761003476), received between Apr 20, 2023 and May 13, 2025 — classified as 1 injury, 1 malfunction.
The most frequently reported specific device problem is “Break” (1 report).
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Break1
- Detachment of Device or Device Component1
Patient problems
- Foreign Body In Patient1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryMay 13, 2025Detachment of Device or Device Component; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING A DIAGNOSTIC LEFT URETEROSCOPY FOR SUSPECTED UROTHELIAL NEOPLASM OF THE KIDNEY, WHEN CLOSING THE BRANCHES OF THE SUBJECT DEVICE DURING THE SECOND BIOPSY ATTEMPT THE FORCEPS WERE DISLODGED AND THE TWO BRANCHES REMAINED WITH THE URETERAL LUMEN. WITH THE AID OF THE ZEROTIP BASKED, ONE OF THE TWO BRANCHES WAS RETRIEVED. SEVERAL ATTEMPTS TO RETRIEVE THE SECOND BRANCH WERE UNSUCCESSFUL DUE TO THE PRESENCE OF CLOTS AND DISEASE OBLITERATING THE URETERAL LUMEN. INTRAOPERATIVE FLUOROSCOPIC IMAGING WAS PERFORMED TO CONFIRM THE PRESENCE OF THE RETAINED BRANCH. THE PROCEDURE WAS COMPLETED, AND THE BIOPSY SAMPLE WAS OBTAINED WITH THE AID OF A BACKUP DEVICE. IT WAS DETERMINED THAT NO ADDITIONAL SURGERY WAS REQUIRED AT THE TIME FOR REMOVAL OF THE RETAINED PIECE AS THE PATIENT WAS A CANDIDATE FOR NEPHROURETERECTOMY PROCEDURE DUE TO PATHOLOGY AND THE FRAGMENT CAN BE REMOVED AT THAT TIME. UNPLANNED ANTIBIOTIC THERAPY WAS ADMINISTERED IN THE POST-OPERATIVE PERIOD TO REDUCE THE RISK OF INFECTION. THE PATIENT WAS DISCHARGED AFTER A FEW DAYS OF OBSERVATION AND SCHEDULED FOR NEPHROURETERECTOMY.
Patient problems: Foreign Body In Patient
MAUDE report 22008483 ↗MalfunctionApr 20, 2023Break; Break
THE CUSTOMER REPORTED THE SEMI FLEXIBLE BIOPSY FORCEPS IS BROKEN. THE PROBLEM WAS CAUSED BY INCORRECT HANDLING BY THE CUSTOMER DURING REPROCESSING. NO DEATH OR INJURY AND NO IMPACT TO PATIENT OR OTHER HAS BEEN REPORTED TO OLYMPUS.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16781833 ↗
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Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.