BIOPSY FORCEPS FB-25K-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170030055), received between Feb 11, 2022 and Sep 2, 2022 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Contamination” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 2, 2022Contamination; Failure to Clean Adequately; Contamination; Failure to Clean Adequately

  THE CUSTOMER REPORTED TO OLYMPUS, THE PHYSICIAN FOUND IT DIFFICULT TO OPEN THE BIOPSY FORCEPS DURING PREPARATION FOR USE FOR AN UNKNOWN PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A REPLACEMENT DEVICE. IT WAS REPORTED THAT THE DEVICE HAD BEEN USED SEVERAL TIMES PRIOR TO THE FAILURE BEING OBSERVED. UPON EVALUATION IT WAS FOUND THAT THERE WAS FOREIGN MATERIAL PRESENT IN THE LINKAGE AT THE DISTAL END OF THE ARMS OF THE CUP. ACCORDING THE CUSTOMER'S SALES REPRESENTATIVE, THE DEVICE HAD BEEN REPROCESSED AND THE USERS HAD NOT OBSERVED ANY CONTAMINATION. THIS MEDICAL DEVICE REPORT (MDR) IS BEING SUBMITTED TO CAPTURE THE REPORTABLE MALFUNCTION FOUND DURING EVALUATION. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15352575 ↗
• InjuryFeb 18, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "COST-EFFECTIVENESS AND SHORT-TERM CLINICAL OUTCOMES OF ARGON PLASMA COAGULATION COMPARED WITH ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE TREATMENT OF GASTRIC LOW-GRADE DYSPLASIA". THIS WAS A RETROSPECTIVE REVIEW STUDY WAS AIMED TO EVALUATE THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) VS. CLINICAL EFFICACY OF ARGON PLASMA COAGULATION (APC) FOR GASTRIC LOW-GRADE DYSPLASIA (LGD) IN TERMS OF CLINICAL EFFICACY AND COST-EFFECTIVENESS. THE STUDY INCLUDED 183 PATIENTS, DIVIDED INTO THE APC GROUP (N=59) AND ESD GROUP (N=124). THE STUDY CLAIMED THAT THE MEAN PROCEDURE TIME, MEAN HOSPITAL STAY, AND PROCEDURE COST WAS SIGNIFICANTLY SHORTER IN THE APC GROUP THAN IN THE ESD GROUP (P<.01). A RESIDUAL TUMOR WAS EVIDENT IN ONE PATIENT AFTER APC TREATMENT, BUT NOT IN THE ESD GROUP, THE RESIDUAL TUMOR WAS TREATED BY APC AGAIN, AND NO RECURRENCE OCCURRED DURING THE FOLLOW-UP PERIOD. IT CONCLUDED APC AS ADVANTAGEOUS OVER ESD RELATED TO SAFETY AND COST-EFFECTIVENESS COMPARED WITH ESD. THEREFORE, APC CAN BE CONSIDERED AN ALTERNATIVE TREATMENT OPTION FOR GASTRIC LGD. THE AUTHORS REPORTED USING 8 DIFFERENT OLYMPUS DEVICES AND DID NOT SPECIFY THE OLYMPUS DEVICE U

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 13564069 ↗
• MalfunctionFeb 11, 2022Device Reprocessing Problem; Device Contamination with Body Fluid; Device Reprocessing Problem; Device Contamination with Body Fluid

  CUSTOMER STATED THEY DID NOT PERFORM A CULTURE TEST. THEY CONFIRMED THEY DID NOT HAVE ANY REPORTS OF INFECTIONS. THE DEVICE HAS BEEN PROPERLY REPROCESSED AND WILL NOT BE RETURNED FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13517557 ↗