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BIOPSY FORCEPS FB-41ST-1Recalls & reported problems

Olympus Medical Systems Corp. · Class 1

Adverse event reports
3
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170048708), received between Aug 23, 2022 and Aug 23, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Contamination” (3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Contamination3

Patient problems

  • No Clinical Signs, Symptoms or Conditions3

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionAug 23, 2022Contamination; Contamination

    CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF THE DEVICE CUP NOT OPENING OR CLOSING OBSERVED UPON INSPECTION. THERE IS NO PATIENT INVOLVEMENT AS THERE NO PROCEDURE TAKING PLACE ON THAT DAY AND NO HARM REPORTED TO ANY PATIENT. THE DEVICE WAS USED IN APPROXIMATELY TWO OR THREE CASES. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE IS FOREIGN MATERIAL ADHERING TO THE ARMS OF THE CUP OF THE DEVICE, WHICH IS THE LINKAGE MECHANISM AT THE DISTAL END. THIS MEDWATCH IS BEING SUBMITTED FOR THE PRESENCE OF FOREIGN MATERIAL IN THE DEVICE AS OBSERVED DURING DEVICE EVALUATION. AT THE FACILITY, CLEANING OF THE DEVICE IS PERFORMED WITH SAKURA SEIKI¿S ULTRASONIC OR REDUCED PRESSURE BOILING. STERILIZATION DONE BY AUTOCLAVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15277842 ↗
  • MalfunctionAug 23, 2022Contamination; Contamination

    CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF THE DEVICE CUP NOT OPENING OR CLOSING OBSERVED UPON INSPECTION. THERE IS NO PATIENT INVOLVEMENT AS THERE NO PROCEDURE TAKING PLACE ON THAT DAY AND NO HARM REPORTED TO ANY PATIENT. THE DEVICE WAS USED IN APPROXIMATELY TWO OR THREE CASES. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE IS FOREIGN MATERIAL ADHERING TO THE ARMS OF THE CUP OF THE DEVICE, WHICH IS THE LINKAGE MECHANISM AT THE DISTAL END. THIS MEDWATCH IS BEING SUBMITTED FOR THE PRESENCE OF FOREIGN MATERIAL IN THE DEVICE AS OBSERVED DURING DEVICE EVALUATION.AT THE FACILITY, CLEANING OF THE DEVICE IS PERFORMED WITH SAKURA SEIKI¿S ULTRASONIC OR REDUCED PRESSURE BOILING. STERILIZATION DONE BY AUTOCLAVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15277839 ↗
  • MalfunctionAug 23, 2022Contamination; Contamination

    CUSTOMER RETURNED THE DEVICE FOR EVALUATION AND REPAIR OF THE DEVICE CUP NOT OPENING OR CLOSING OBSERVED UPON INSPECTION. THERE IS NO PATIENT INVOLVEMENT AS THERE NO PROCEDURE TAKING PLACE ON THAT DAY AND NO HARM REPORTED TO ANY PATIENT. THE DEVICE WAS USED IN APPROXIMATELY TWO OR THREE CASES. UPON EVALUATION OF THE RETURNED DEVICE, IT WAS OBSERVED THAT THERE IS FOREIGN MATERIAL ADHERING TO THE ARMS OF THE CUPS OF THE DEVICE, WHICH IS THE LINKAGE MECHANISM AT THE DISTAL END. THIS MEDWATCH IS BEING SUBMITTED FOR THE PRESENCE OF FOREIGN MATERIAL IN THE DEVICE AS OBSERVED DURING DEVICE EVALUATION. AT THE FACILITY, CLEANING OF THE DEVICE IS PERFORMED WITH SAKURA SEIKI¿S ULTRASONIC OR REDUCED PRESSURE BOILING. STERILIZATION DONE BY AUTOCLAVE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 15277655 ↗

Other Forceps, Biopsy, Non-Electric devices

All Forceps, Biopsy, Non-Electric devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.