DISPOSABLE BIOPSY FORCEPS FB-231D (REF N5432030)Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04953170389559), received between Mar 15, 2019 and Mar 8, 2024 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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. 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMar 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A ROBOTIC LUNG NAVIGATION PROCEDURE, THE TIP BROKE OFF INSIDE THE PATIENT'S LUNG. THE TIP WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867906 ↗
• InjuryMar 8, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED DURING A ROBOTIC LUNG NAVIGATION PROCEDURE, THE TIP BROKE OFF INSIDE THE PATIENT'S LUNG. THE TIP WAS RETRIEVED AND THE PROCEDURE WAS COMPLETED. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18867882 ↗
• MalfunctionNov 12, 2019Break; Break

  DURING A BRONCHIAL BIOPSY, THE SUBJECT DEVICE WAS USED. AFTER THE FIRST BIOPSY, THE FIRST ONE OF TWO SUBJECT DEVICES WAS REINTRODUCED INTO THE SCOPE FOR THE SECOND BIOPSY. TWO WIRES PROTRUDED FROM BOTH SIDES OF BIOPSY CUPS WHEN THE BIOPSY CUPS WAS OPENED. THE USER CLOSED CUPS AND REMOVED THE SUBJECT DEVICE FROM A BRONCHOSCOPE. TO TRY THE SECOND BIOPSY AGAIN, THE SECOND ONE OF TWO SUBJECT DEVICES WAS REINTRODUCED INTO THE SCOPE. AFTER THE BIOPSY, TWO WIRES PROTRUDED FROM BOTH SIDES OF BIOPSY CUPS WHEN THE BIOPSY CUPS WAS OPENED AGAIN. THE USER CLOSED CUPS AND REMOVED THE SUBJECT DEVICE IMMEDIATELY FROM A BRONCHOSCOPE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON OCTOBER 23, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE MANIPULATION WIRES OF THE BOTH DEVICE HAD LOST THE PRESSED PORTIONS. THIS IS THE FIRST ONE OF TWO REPORTS. THIS IS THE REPORT REGARDING THE MISSING OF THE MANIPULATION WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313484 ↗
• MalfunctionNov 12, 2019Break; Break

  DURING A BRONCHIAL BIOPSY, THE SUBJECT DEVICE WAS USED. AFTER THE FIRST BIOPSY, THE FIRST ONE OF TWO SUBJECT DEVICES WAS REINTRODUCED INTO THE SCOPE FOR THE SECOND BIOPSY. TWO WIRES PROTRUDED FROM BOTH SIDES OF BIOPSY CUPS WHEN THE BIOPSY CUPS WAS OPENED. THE USER CLOSED CUPS AND REMOVED THE SUBJECT DEVICE FROM A BRONCHOSCOPE. TO TRY THE SECOND BIOPSY AGAIN, THE SECOND ONE OF TWO SUBJECT DEVICES WAS REINTRODUCED INTO THE SCOPE. AFTER THE BIOPSY, TWO WIRES PROTRUDED FROM BOTH SIDES OF BIOPSY CUPS WHEN THE BIOPSY CUPS WAS OPENED AGAIN. THE USER CLOSED AND REMOVED THE SUBJECT DEVICE IMMEDIATELY FROM A BRONCHOSCOPE. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. ON OCTOBER 23, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE MANIPULATION WIRES OF THE BOTH DEVICE HAD LOST THE PRESSED PORTIONS. THIS IS THE SECOND ONE OF TWO REPORTS. THIS IS THE REPORT REGARDING THE MISSING OF THE MANIPULATION WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9313482 ↗
• MalfunctionMar 15, 2019Break; Break

  DURING A BRONCHIAL BIOPSY, SUBJECT DEVICE WAS USED. THE CUP OF THE SUBJECT DEVICE WAS NOT OPEN. THE INTENDED PROCEDURE WAS CONTINUED WITH ANOTHER DEVICE. ON MARCH 6, 2019, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) FOUND THAT THE WIRE OF SUBJECT DEVICE WAS PARTIALLY MISSING. NO PATIENT INJURY WAS REPORTED. THIS IS THE REPORT REGARDING THE MISSING WIRE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8423667 ↗