BIOPSY FORCEPS FB-56D-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 04953170048821), received between Feb 19, 2020 and Dec 9, 2022 — classified as 5 injuries, 1 malfunction.

The most frequently reported specific device problem is “Break” (1 report).

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 9, 2022Break; Break

  THE CUSTOMER REPORTED THAT, DURING A BIOPSY OF THE URETER (FLEXIBLE URETEROSCOPY), THE FORCEPS COULD NOT BE OPENED WHEN THE BIOPSY WAS RETRIEVED. THE HANDLE WORKED BUT THE CUP ON THE SUBJECT DEVICE REMAINED CLOSED. THIS CAUSED A FIVE MINUTE DELAY IN THE PROCEDURE. THERE WAS NO EFFECT ON THE PATIENT DUE TO THE EVENT. THE SUBJECT DEVICE WAS SENT TO OLYMPUS FOR EVALUATION. DURING INSPECTION AND TESTING, THE ARMS OF THE CAPS (A PART OF THE LINKAGE MECHANISM AT THE DISTAL END) WAS BROKEN OFF. THIS REPORT IS BEING SUBMITTED FOR THE MALFUNCTION FOUND DURING EVALUATION (BROKEN ARMS).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15955244 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "STEEP INFUNDIBULOPELVIC ANGLE AS A NEW RISK FACTOR FOR FLEXIBLE URETEROSCOPE DAMAGE AND COMPLICATED POSTOPERATIVE COURSE. " THE LITERATURE REPORTED THE RESULT OF 381 CASES OF THE FLEXIBLE URETEROSCOPY (FURS) PROCEDURES USING AN OLYMPUS MODEL URF-V (URETEROSCOPE) AND FB-56D-1 (BIOPSY FORCEPS) BETWEEN SEPTEMBER 2013 AND MARCH 2017. IN THE SUBJECT PROCEDURES, THE FOLLOWING CASES REPORTEDLY OCCURRED. 4 BLEEDING COMPLICATION CASES. 27 URINARY TRACT INFECTION CASES, 5 PERFORATION CASES OF THE UPPER URINARY TRACT. 2 PNEUMONIA CASES. 2 UNKNOWN COMPLICATIONS BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF ACCIDENTAL SYMPTOMS AND THE NUMBER OF OLYMPUS DEVICES USED FOR THE PROCEDURES, OMSC IS SUBMITTING 10 MEDICAL DEVICE REPORTS. THIS REPORT IS 8TH OF 10 REPORTS FOR UNKNOWN COMPLICATIONS AND FB-56D-1.

  Patient problems: Injury

  MAUDE report 9726304 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "STEEP INFUNDIBULOPELVIC ANGLE AS A NEW RISK FACTOR FOR FLEXIBLE URETEROSCOPE DAMAGE AND COMPLICATED POSTOPERATIVE COURSE. " THE LITERATURE REPORTED THE RESULT OF 381 CASES OF THE FLEXIBLE URETEROSCOPY (FURS) PROCEDURES USING AN OLYMPUS MODEL URF-V (URETEROSCOPE) AND FB-56D-1 (BIOPSY FORCEPS) BETWEEN SEPTEMBER 2013 AND MARCH 2017. IN THE SUBJECT PROCEDURES, THE FOLLOWING CASES REPORTEDLY OCCURRED. 4 BLEEDING COMPLICATION CASES. 27 URINARY TRACT INFECTION CASES. 5 PERFORATION CASES OF THE UPPER URINARY TRACT. 2 PNEUMONIA CASES. 2 UNKNOWN COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF ACCIDENTAL SYMPTOMS AND THE NUMBER OF OLYMPUS DEVICES USED FOR THE PROCEDURES, OMSC IS SUBMITTING 10 MEDICAL DEVICE REPORTS. THIS REPORT IS 4TH OF 10 REPORTS FOR PERFORATION OF THE UPPER URINARY TRACT AND FB-56D-1.

  Patient problems: Injury

  MAUDE report 9726301 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "STEEP INFUNDIBULOPELVIC ANGLE AS A NEW RISK FACTOR FOR FLEXIBLE URETEROSCOPE DAMAGE AND COMPLICATED POSTOPERATIVE COURSE." THE LITERATURE REPORTED THE RESULT OF 381 CASES OF THE FLEXIBLE URETEROSCOPY (FURS) PROCEDURES USING AN OLYMPUS MODEL URF-V (URETEROSCOPE) AND FB-56D-1 (BIOPSY FORCEPS) BETWEEN SEPTEMBER 2013 AND MARCH 2017. IN THE SUBJECT PROCEDURES, THE FOLLOWING CASES REPORTEDLY OCCURRED. 4 BLEEDING COMPLICATION CASES. 27 URINARY TRACT INFECTION CASES. 5 PERFORATION CASES OF THE UPPER URINARY TRACT. 2 PNEUMONIA CASES. 2 UNKNOWN COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF ACCIDENTAL SYMPTOMS AND THE NUMBER OF OLYMPUS DEVICES USED FOR THE PROCEDURES, OMSC IS SUBMITTING 10 MEDICAL DEVICE REPORTS. THIS REPORT IS 6TH OF 10 REPORTS FOR PNEUMONIA AND FB-56D-1.

  Patient problems: Injury

  MAUDE report 9726299 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "STEEP INFUNDIBULOPELVIC ANGLE AS A NEW RISK FACTOR FOR FLEXIBLE URETEROSCOPE DAMAGE AND COMPLICATED POSTOPERATIVE COURSE." THE LITERATURE REPORTED THE RESULT OF 381 CASES OF THE FLEXIBLE URETEROSCOPY (FURS) PROCEDURES USING AN OLYMPUS MODEL URF-V (URETEROSCOPE) AND FB-56D-1 (BIOPSY FORCEPS) BETWEEN SEPTEMBER 2013 AND MARCH 2017. IN THE SUBJECT PROCEDURES, THE FOLLOWING CASES REPORTEDLY OCCURRED. 4 BLEEDING COMPLICATION CASES. 27 URINARY TRACT INFECTION CASES. 5 PERFORATION CASES OF THE UPPER URINARY TRACT. 2 PNEUMONIA CASES. 2 UNKNOWN COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF ACCIDENTAL SYMPTOMS AND THE NUMBER OF OLYMPUS DEVICES USED FOR THE PROCEDURES, OMSC IS SUBMITTING 10 MEDICAL DEVICE REPORTS. THIS REPORT IS 2ND OF 10 REPORTS FOR URINARY TRACT INFECTION AND FB-56D-1.

  Patient problems: Injury

  MAUDE report 9726298 ↗
• InjuryFeb 19, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "STEEP INFUNDIBULOPELVIC ANGLE AS A NEW RISK FACTOR FOR FLEXIBLE URETEROSCOPE DAMAGE AND COMPLICATED POSTOPERATIVE COURSE. " THE LITERATURE REPORTED THE RESULT OF 381 CASES OF THE FLEXIBLE URETEROSCOPY (FURS) PROCEDURES USING AN OLYMPUS MODEL URF-V (URETEROSCOPE) AND FB-56D-1 (BIOPSY FORCEPS) BETWEEN SEPTEMBER 2013 AND MARCH 2017. IN THE SUBJECT PROCEDURES, THE FOLLOWING CASES REPORTEDLY OCCURRED. 4 BLEEDING COMPLICATION CASES. 27 URINARY TRACT INFECTION CASES. 5 PERFORATION CASES OF THE UPPER URINARY TRACT . 2 PNEUMONIA CASES. 2 UNKNOWN COMPLICATIONS. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENTS COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF ACCIDENTAL SYMPTOMS AND THE NUMBER OF OLYMPUS DEVICES USED FOR THE PROCEDURES, OMSC IS SUBMITTING 10 MEDICAL DEVICE REPORTS. THIS REPORT IS 3RD OF 10 REPORTS FOR BLEEDING COMPLICATIONS AND FB-56D-1.

  Patient problems: Injury

  MAUDE report 9726297 ↗