DISPOSABLE BIOPSY FORCEPS FB-211D (REF N5431830)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170389535), received between Jul 15, 2019 and Dec 27, 2023 — classified as 2 injuries, 2 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.

• InjuryDec 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: THE PATIENT HAS HAD AN MRI AND IT WAS REPORTED THAT WHAT THE USER HAD SEEN WAS SOMETHING FROM A BREAST SURGERY AND NOT FROM THE LUNG BRONCHOSCOPY.

  Patient problems: Foreign Body In Patient

  MAUDE report 18396977 ↗
• MalfunctionMay 19, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DISPOSABLE BIOPSY FORCEPS JAWS BROKE INSIDE THE PATIENT'S LUNGS. ON EXAMINATION, AN INTERNAL WIRE PROTRUDES FROM THE FORCEPS WHEN THE JAWS OPEN, POTENTIALLY LEADING TO UNINTENDED INJURY TO THE PATIENT'S AIRWAY. NO PART OF THE FORCEPS FELL INTO THE PATIENT'S LUNGS. THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE AFTER A 4-MINUTE DELAY. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16968180 ↗
• InjurySep 16, 2022Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS, DURING A BRONCHOSCOPY, THE BIOPSY FORCEPS BROKE. WHEN THE FORCEPS BROKE, THE WIRES THAT MOVE THE FORCEPS BLADES WERE RELEASED AND PROTRUDED ABOUT 1.5 CM CAUSING DAMAGE TO THE PATIENT AND THE NON-OLYMPUS ENDOSCOPE, WHEN OPENING AND CLOSING AND PERFORMING MOVEMENTS FROM THE HANDLE. THE PROCEDURE WAS COMPLETED WITH SIMILAR FORCEPS. ON THE SAME DAY OF THE PROCEDURE WITH DEVICE MALFUNCTION, THE PATIENT PRESENTED WITH SYMPTOMS OF A PNEUMOTHORAX. THE PNEUMOTHORAX WAS TREATED AND THE PATIENT REMAINED IN THE HOSPITAL. THE CUSTOMER REPORTED IT IS UNKNOWN IF THE EVENT IS DIRECTLY RELATED TO DEVICE MALFUNCTION DURING THE PROCEDURE.

  Patient problems: Pneumothorax

  MAUDE report 15437634 ↗
• MalfunctionJul 15, 2019Break; Break

  SERVICE CENTER WAS INFORMED THAT DURING A BIOPSY, THE FORCEPS WERE REMOVED, AND MALFUNCTIONED UPON DEPOSITING THE BIOPSY IN A SPECIMEN CUP. A NEW SET OF FORCEPS WAS USED FOR ADDITIONAL BIOPSIES AND THE PROCEDURE WAS CONCLUDED WITHOUT ANY COMPLICATIONS. THERE WERE NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8790952 ↗