DISPOSABLE BIOPSY FORCEPS FB-244U (UDI 04953170304613)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170304613), received between Oct 23, 2018 and Oct 23, 2018 — classified as 5 injuries.

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

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT THE USER FACILITY¿S PHYSICIANS REPORTED FEELING A TEARING SENSATION WHEN USING THE SINGLE USE BIOPSY FORCEPS, AS A RESULT 5 TO 6 PATIENTS EXPERIENCED EXCESSIVE BLEEDING AND HEMATOMAS. CLIPS WERE USED TO TREAT THE BLEEDING AND CLOSE THE AFFECTED SITE. IT IS UNKNOWN IF THE INTENDED PROCEDURES WERE COMPLETED. ADDITIONALLY, IT WAS REPORTED THAT THE CLINICIANS WERE NEW TO THE USE OF THIS FORCEP, ALTHOUGH A PREVIOUS TRIAL WAS COMPLETED. THIS IS REPORT 2 OF 6.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7997568 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT THE USER FACILITY¿S PHYSICIANS REPORTED FEELING A TEARING SENSATION WHEN USING THE SINGLE USE BIOPSY FORCEPS, AS A RESULT 5 TO 6 PATIENTS EXPERIENCED EXCESSIVE BLEEDING AND HEMATOMAS. CLIPS WERE USED TO TREAT THE BLEEDING AND CLOSE THE AFFECTED SITE. IT IS UNKNOWN IF THE INTENDED PROCEDURES WERE COMPLETED. ADDITIONALLY, IT WAS REPORTED THAT THE CLINICIANS WERE NEW TO THE USE OF THIS FORCEP, ALTHOUGH A PREVIOUS TRIAL WAS COMPLETED. THIS IS REPORT 4 OF 6.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7997533 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT THE USER FACILITY¿S PHYSICIANS REPORTED FEELING A TEARING SENSATION WHEN USING THE SINGLE USE BIOPSY FORCEPS, AS A RESULT 5 TO 6 PATIENTS EXPERIENCED EXCESSIVE BLEEDING AND HEMATOMAS. CLIPS WERE USED TO TREAT THE BLEEDING AND CLOSE THE AFFECTED SITE. IT IS UNKNOWN IF THE INTENDED PROCEDURES WERE COMPLETED. ADDITIONALLY, IT WAS REPORTED THAT THE CLINICIANS WERE NEW TO THE USE OF THIS FORCEP, ALTHOUGH A PREVIOUS TRIAL WAS COMPLETED.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7997530 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT THE USER FACILITY¿S PHYSICIANS REPORTED FEELING A TEARING SENSATION WHEN USING THE SINGLE USE BIOPSY FORCEPS, AS A RESULT 5 TO 6 PATIENTS EXPERIENCED EXCESSIVE BLEEDING AND HEMATOMAS. CLIPS WERE USED TO TREAT THE BLEEDING AND CLOSE THE AFFECTED SITE. IT IS UNKNOWN IF THE INTENDED PROCEDURES WERE COMPLETED. ADDITIONALLY, IT WAS REPORTED THAT THE CLINICIANS WERE NEW TO THE USE OF THIS FORCEP, ALTHOUGH A PREVIOUS TRIAL WAS COMPLETED. THIS REPORT 6 OF 6.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7997520 ↗
• InjuryOct 23, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS WAS INFORMED THAT THE USER FACILITY¿S PHYSICIANS REPORTED FEELING A TEARING SENSATION WHEN USING THE SINGLE USE BIOPSY FORCEPS, AS A RESULT 5 TO 6 PATIENTS EXPERIENCED EXCESSIVE BLEEDING AND HEMATOMAS. CLIPS WERE REQUIRED TO TREAT THE BLEEDING AND CLOSE THE AFFECTED SITE. ADDITIONALLY, IT WAS REPORTED THAT THE PHYSICIANS INVOLVED IN THESE CASES WERE NEW DEVICE USERS. THIS IS REPORT 1 OF 6.

  Patient problems: Blood Loss; Hematoma

  MAUDE report 7997508 ↗