DISPOSABLE BIOPSY FORCEPS FB-211D (UDI 04953170158124)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170158124), received between Dec 21, 2018 and Oct 26, 2022 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Break” (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. 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTS, JUST AFTER A FIBEROSCOPY FOR LUNG BIOPSY USING A DISPOSABLE BIOPSY FORCEPS, THE PATIENT EXPERIENCED SEVERE DETERIORATION OF THE PATIENT'S HEALTH CONDITION CHARACTERIZED BY CHEST PAIN FOLLOWED BY VAGAL DISCOMFORT RESULTING IN HYPOTENSION (BLOOD PRESSURE 70/50) AND BRADYCARDIA (HEART RATE 40BPM). A CHEST X-RAY WAS TAKEN AND SHOWED. NON-COMPRESSIVE LEFT PNEUMOTHORAX. THE PATIENT NECESSITATED 24-HOUR HOSPITALIZATION FOR PAIN MANAGEMENT (MORPHINE ADMINISTRATION) AND MONITORING. NO ADDITIONAL CONSEQUENCES TO THE PATIENT WERE REPORTED. THE SUSPECT DEVICE CANNOT BE RETURNED TO OLYMPUS FOE EVALUATION (IT WAS RETAINED BY THE FACILITY).

  Patient problems: Bradycardia; Chest Pain; Low Blood Pressure/ Hypotension; Pneumothorax

  MAUDE report 15674315 ↗
• MalfunctionMay 30, 2019Break; Break

  THE USER FACILITY REPORTED THAT DURING A BRONCHOSCOPY PROCEDURE THE JAWS BROKE OFF INTO THE SCOPE WHILE THE DEVICE WAS BEING WITHDRAWN; IT NEVER FELL INTO THE PATIENT. THERE WAS NO PATIENT HARM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. IN ADDITION, USER FACILITY REPORTED THAT THE BEFORE THE BREAKAGE, THE BRONCHOSCOPE WAS FLEXED TO THE RIGHT UPPER LOBE (RUL) APICAL SEGMENT IN ORDER TO OBTAIN A BIOPSY. THE FORCEPS WOULD NOT ADVANCE AND WAS WITHDRAWN. THE BRONCHOSCOPE WAS THEN BACKED OUT SLIGHTLY AND STRAIGHTENED OUT. THE FORCEPS WAS ADVANCED AGAIN AND THEN THE SCOPE WAS FLEXED INTO THE RUL APICAL SEGMENT AGAIN. THE SCOPE COULD NOT FLEX ADEQUATELY AND THE SCOPE WAS AGAIN STRAIGHTENED OUT. THE BRONCHOSCOPE WAS RETRACTED AND FORCEPS REMOVED. A NEW BIOPSY LOCATION IN THE LINGUAL WAS THEN CHOSEN AS AN ALTERNATE SITE. PRIOR TO RE-INSERTING THE FORCEPS THE TECHNICIAN NOTED THAT ONE OF THE FORCEPS ARMS WAS MISSING. A SEARCH WAS PERFORMED FOR THE MISSING PART. IT WAS FOUND IN THE FILTER OF THE SUCTION CANISTER. THE PROCEDURE WAS THEN COMPLETED WITHOUT DIFFICULTY AND WITH NO ADVERSE PATIENT EFFECT. THE ONLY PROCEDURAL ISSUE WAS NOT BEING ABLE TO GET BIOPSIES FROM THE ORIGINAL RUL APICAL SEGME

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8654595 ↗
• MalfunctionDec 21, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, THE JAWS FROM TWO FORCEPS BROKE ALLOWING THE WIRES TO PROTRUDE FROM THE DISTAL END OF THE DEVICES. NO DEVICE FRAGMENT FELL INTO THE PATIENT. IT WAS REPORTED THAT THERE WAS A POPPING NOISE NOTED WHEN THE JAWS CLOSED. THE DOCTOR WAS ABLE TO RETRIEVE THE INTENDED SPECIMENS. THERE WAS NO UNUSUAL BLEEDING OBSERVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A THIRD SIMILAR DEVICE. THERE WAS NO PATIENT INJURY. THIS IS REPORT 2 OF 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192359 ↗
• MalfunctionDec 21, 2018Break; Break

  OLYMPUS WAS INFORMED THAT DURING A DIAGNOSTIC BRONCHOSCOPY PROCEDURE, THE JAWS FROM TWO FORCEPS BROKE ALLOWING THE WIRES TO PROTRUDE FROM THE DISTAL END OF THE DEVICES. NO DEVICE FRAGMENT FELL INTO THE PATIENT. IT WAS REPORTED THAT THERE WAS A POPPING NOISE NOTED WHEN THE JAWS CLOSED. THE DOCTOR WAS ABLE TO RETRIEVE THE INTENDED SPECIMENS. THERE WAS NO UNUSUAL BLEEDING OBSERVED. THE INTENDED PROCEDURE WAS COMPLETED WITH A THIRD SIMILAR DEVICE. THERE WAS NO PATIENT INJURY. THIS IS REPORT 1 OF 2.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8192345 ↗