DISPOSABLE BIOPSY FORCEPS FB-230KRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04953170354090), received between Jun 5, 2019 and Jun 5, 2019 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Use of Device Problem” (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

Recent adverse event reports

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

• MalfunctionJun 5, 2019Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC GASTROSCOPY PROCEDURE THAT ONCE THE DEVICE WAS WITHDRAWN FROM THE GASTROSCOPE, THE MUCOSA SAMPLE WAS REPORTEDLY OBSERVED TO BE TORN OFF AND DID NOT FIT INSIDE THE CUP OF THE FORCEPS. THE PIECE OF MUCOUS FELL INTO THE PATIENT'S INTESTINE. THERE WAS NO PATIENT INJURY REPORTED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE (FROM DIFFERENT LOT #, 87V). NO OTHER EQUIPMENT WAS REPLACED DURING PROCEDURE. THE USER FACILITY REPORTED THIS PROBLEM HAS OCCURRED WITH OTHER FORCEPS FROM THE SAME LOT NUMBER AND WITH THREE DIFFERENT SURGEONS. THIS IS FOR REPORT 3 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670173 ↗
• MalfunctionJun 5, 2019Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC GASTROSCOPY PROCEDURE THAT ONCE THE DEVICE WAS WITHDRAWN FROM THE GASTROSCOPE, THE MUCOSA SAMPLE WAS REPORTEDLY OBSERVED TO BE TORN OFF AND DID NOT FIT INSIDE THE CUP OF THE FORCEPS. THE PIECE OF MUCOUS FELL INTO THE PATIENT'S INTESTINE. THERE WAS NO PATIENT INJURY REPORTED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE (FROM DIFFERENT LOT#, 87V). NO OTHER EQUIPMENT WAS REPLACED DURING PROCEDURE. THE USER FACILITY REPORTED THIS PROBLEM HAS OCCURRED WITH OTHER FORCEPS FROM THE SAME LOT NUMBER AND WITH THREE DIFFERENT SURGEONS. THIS IS FOR REPORT 2 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670149 ↗
• MalfunctionJun 5, 2019Use of Device Problem; Use of Device Problem

  THE USER FACILITY REPORTED THAT DURING A DIAGNOSTIC GASTROSCOPY PROCEDURE THAT ONCE THE DEVICE WAS WITHDRAWN FROM THE GASTROSCOPE, THE MUCOSA SAMPLE WAS REPORTEDLY OBSERVED TO BE TORN OFF AND DID NOT FIT INSIDE THE CUP OF THE FORCEPS. THE PIECE OF MUCOUS FELL INTO THE PATIENT'S INTESTINE. THERE WAS NO PATIENT INJURY REPORTED. THE INTENDED PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE (FROM DIFFERENT LOT #, 87V). NO OTHER EQUIPMENT WAS REPLACED DURING PROCEDURE. THE USER FACILITY REPORTED THIS PROBLEM HAS OCCURRED WITH OTHER FORCEPS FROM THE SAME LOT NUMBER AND WITH THREE DIFFERENT SURGEONS. THIS IS FOR REPORT 1 OF 3.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8670138 ↗