BIOPSY FORCEPS FB-28U-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170030161), received between Sep 12, 2021 and Apr 21, 2022 — classified as 2 malfunctions.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 21, 2022Contamination; Contamination

  THE CUSTOMER REPORTED THAT WHEN PREPARING THE SUBJECT DEVICE FOR USE DURING A DIAGNOSTIC BIOPSY PROCEDURE, AFTER RE-STERILIZING AND BEFORE USE, THE CUPS WOULD NOT OPEN. THE INTENDED PROCEDURE WAS COMPLETED USING ANOTHER SIMILAR DEVICE. THERE WAS NO PATIENT OR USER INJURY REPORTED DUE TO THE EVENT. THE DEVICE WAS RETURNED TO AN OLYMPUS SERVICE CENTER FOR EVALUATION. UPON INSPECTION AND TESTING OF THE RETURNED DEVICE, IT WAS OBSERVED THAT FOREIGN MATERIAL WAS ADHERED TO THE ARMS OF THE CUPS (THE LINKAGE MECHANISM AT THE DISTAL END). THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION OF THE DEVICE (PRESENCE OF FOREIGN MATERIAL).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14173174 ↗
• MalfunctionSep 12, 2021Break; Break

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED FROM USER FACILITY THAT DURING A HISTOLOGY PROCEDURE JAMMING OF THE HANDLE OCCURRED AND THE JAMMING LED TO THE HALF CLOSURE OF CUPS, BUT AFTER SEVERAL PUSHES OF HANDLE CUSTOMER MANAGED TO CLOSE CUPS. THERE WAS NO REPORT OF PATIENT INJURY ASSOCIATED WITH THE EVENT. THE SUBJECT DEVICE WAS RETURNED TO OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOR EVALUATION. THE OMSC CONFIRMED THE FOLLOWING EVENT ON (B)(6) 2021 AND DETERMINED THAT IT WAS AN MEDICAL DEVICE REPORT (MDR) REPORTABLE EVENT. THE WELDED PORTION TO JOIN THE CUPS AND THE WIRE WAS DETACHED FROM THE LINKAGE MECHANISM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12457968 ↗