DISPOSABLE BIOPSY FORCEPS FB-231K (REF N5431630)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04953170389511), received between May 31, 2018 and Jun 1, 2018 — classified as 4 injuries.

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.

• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENTS REGARDING POSTOPERATIVE BLEEDING AFTER BIOPSY WERE REPORTED IN THE 95TH CONGRESS OF THE (B)(6) GASTROENTEROLOGICAL ENDOSCOPY SOCIETY. ARTICLE TITLE: CLINICAL STUDY OF BLEEDING OF PATIENTS UNDER ANTITHROMBOTIC TREATMENT AFTER ENDOSCOPIC BIOPSY FOR UPPER GASTROINTESTINAL TRACT THE TOTAL CASES WERE 33,295. THEY WERE PERFORMED FROM MARCH 2011 TO FEBRUARY 2017. FB-231KS WERE USED FOR UPPER ENDOSCOPIC EXAMINATIONS. ONE WEEK LATER AFTER THE EXAMINATION, THE DOCTOR ASKED ALL PATIENTS WHETHER BLEEDING OCCURRED. IN THE STUDY, ACCIDENTAL BLEEDING OF 4 CASES OCCURRED AFTER GASTRIC BIOPSY AS FOLLOWS. GROUP OF NON-TAKING ANTITHROMBOTIC MEDICINE: 2 CASES GROUP OF TAKING ANTIPLATELET AGENT: 1 CASE GROUP OF TAKING ANTICOAGULANT AGENT: 1 CASE ALL CASES WERE TREATED ENDOSCOPICALLY. THE MALFUNCTION OF FB-231KS WAS NOT REPORTED. THIS REPORT IS REGARDING 4 OF 4 ACCIDENTAL BLEEDING CASES.

  Patient problems: Blood Loss

  MAUDE report 7559460 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENTS REGARDING POSTOPERATIVE BLEEDING AFTER BIOPSY WERE REPORTED IN THE 95TH CONGRESS OF THE (B)(6) GASTROENTEROLOGICAL ENDOSCOPY SOCIETY. ARTICLE TITLE: CLINICAL STUDY OF BLEEDING OF PATIENTS UNDER ANTITHROMBOTIC TREATMENT AFTER ENDOSCOPIC BIOPSY FOR UPPER GASTROINTESTINAL TRACT THE TOTAL CASES WERE 33,295. THEY WERE PERFORMED FROM MARCH 2011 TO FEBRUARY 2017. FB-231KS WERE USED FOR UPPER ENDOSCOPIC EXAMINATIONS. ONE WEEK LATER AFTER THE EXAMINATION, THE DOCTOR ASKED ALL PATIENTS WHETHER BLEEDING OCCURRED. IN THE STUDY, ACCIDENTAL BLEEDING OF 4 CASES OCCURRED AFTER GASTRIC BIOPSY AS FOLLOWS. GROUP OF NON-TAKING ANTITHROMBOTIC MEDICINE: 2 CASES GROUP OF TAKING ANTIPLATELET AGENT: 1 CASE GROUP OF TAKING ANTICOAGULANT AGENT: 1 CASE ALL CASES WERE TREATED ENDOSCOPICALLY. THE MALFUNCTION OF FB-231KS WAS NOT REPORTED. THIS REPORT IS REGARDING 3 OF 4 ACCIDENTAL BLEEDING CASES.

  Patient problems: Blood Loss

  MAUDE report 7559459 ↗
• InjuryJun 1, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENTS REGARDING POSTOPERATIVE BLEEDING AFTER BIOPSY WERE REPORTED IN THE 95TH CONGRESS OF THE (B)(6) GASTROENTEROLOGICAL ENDOSCOPY SOCIETY. ARTICLE TITLE: CLINICAL STUDY OF BLEEDING OF PATIENTS UNDER ANTITHROMBOTIC TREATMENT AFTER ENDOSCOPIC BIOPSY FOR UPPER GASTROINTESTINAL TRACT THE TOTAL CASES WERE 33,295. THEY WERE PERFORMED FROM MARCH 2011 TO FEBRUARY 2017. FB-231KS WERE USED FOR UPPER ENDOSCOPIC EXAMINATIONS. ONE WEEK LATER AFTER THE EXAMINATION, THE DOCTOR ASKED ALL PATIENTS WHETHER BLEEDING OCCURRED. IN THE STUDY, ACCIDENTAL BLEEDING OF 4 CASES OCCURRED AFTER GASTRIC BIOPSY AS FOLLOWS. GROUP OF NON-TAKING ANTITHROMBOTIC MEDICINE: 2 CASES GROUP OF TAKING ANTIPLATELET AGENT: 1 CASE GROUP OF TAKING ANTICOAGULANT AGENT: 1 CASE ALL CASES WERE TREATED ENDOSCOPICALLY. THE MALFUNCTION OF FB-231KS WAS NOT REPORTED. THIS REPORT IS REGARDING 2 OF 4 ACCIDENTAL BLEEDING CASES.

  Patient problems: Blood Loss

  MAUDE report 7559453 ↗
• InjuryMay 31, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING EVENTS REGARDING POSTOPERATIVE BLEEDING AFTER BIOPSY WERE REPORTED IN THE 95TH CONGRESS OF THE (B)(6) GASTROENTEROLOGICAL ENDOSCOPY SOCIETY. ARTICLE TITLE: CLINICAL STUDY OF BLEEDING OF PATIENTS UNDER ANTITHROMBOTIC TREATMENT AFTER ENDOSCOPIC BIOPSY FOR UPPER GASTROINTESTINAL TRACT THE TOTAL CASES WERE 33,295. THEY WERE PERFORMED FROM (B)(6) 2011 TO (B)(6) 2017. FB-231KS WERE USED FOR UPPER ENDOSCOPIC EXAMINATIONS. ONE WEEK LATER AFTER THE EXAMINATION, THE DOCTOR ASKED ALL PATIENTS WHETHER BLEEDING OCCURRED. IN THE STUDY, ACCIDENTAL BLEEDING OF 4 CASES OCCURRED AFTER GASTRIC BIOPSY AS FOLLOWS. GROUP OF NON-TAKING ANTITHROMBOTIC MEDICINE: 2 CASES; GROUP OF TAKING ANTIPLATELET AGENT: 1 CASE; GROUP OF TAKING ANTICOAGULANT AGENT: 1 CASE; ALL CASES WERE TREATED ENDOSCOPICALLY; THE MALFUNCTION OF FB-231KS WAS NOT REPORTED; THIS REPORT IS REGARDING 1 OF 4 ACCIDENTAL BLEEDING CASES.

  Patient problems: Blood Loss

  MAUDE report 7556092 ↗