DISPOSABLE BIOPSY FORCEPS FB-230U (UDI 04953170031120)Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 04953170031120), received between Aug 19, 2022 and Aug 14, 2024 — classified as 6 injuries, 1 malfunction.

The most frequently reported specific device problem is “Dull, Blunt” (4 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING UPPER ENDOSCOPY AND COLONOSCOPY DIAGNOSTIC PROCEDURES, A FORCEPS WAS USED TO TAKE SAMPLES FROM THE STOMACH AND COLON. DURING THE FOURTH BIOPSY IN THE COLON, A PORTION OF THE MUCOSA WAS TORN, CAUSING BLEEDING AND NECESSITATING THE USE OF TWO HEMOSTATIC CLIPS TO ACHIEVE HEMOSTASIS. THE USE OF THE CLIPS DID CAUSE A DELAY OF AN UNKNOWN TIMEFRAME, BUT THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT IMPACT TO THE DIAGNOSTIC OUTCOME OR THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19983279 ↗
• MalfunctionJun 16, 2023Contamination; Contamination

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE DOCTOR WAS USING THE DISPOSABLE BIOPSY FORCEPS TO COMPLETE A DIAGNOSTIC COLONOSCOPY PROCEDURE. PRIOR TO BEGINNING THE PROCEDURE, THE NURSE HAD EXAMINED AND TESTED THE DEVICE WITH NO ISSUES DETECTED. THEN WHEN USING THE DISPOSABLE BIOPSY FORCEPS, THE DOCTOR NOTICED SOMETHING RESEMBLING A BLACK THREAD AT THE HINGE OF THE FORCEPS CUP FROM THE MONITOR. THE FORCEPS WAS WITHDRAWN AND CHANGED TO A NEW ONE TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17144435 ↗
• InjuryMar 3, 2023Dull, Blunt; Dull, Blunt

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A DISPOSABLE BIOPSY FORCEPS TO RETRIEVE SAMPLE TISSUE DURING A COLONOSCOPY, THE JAW WAS NOT SHARP. HIS CAUSED A BAD CUTTING BORDER. ADDITIONALLY IT TORE TISSUE IN THE COLON AND MODERATE (ALSO REPORTED AS "INTERMEDIATE") BLEEDING OCCURRED. THE BLEEDING WAS STOPPED WITH MULTIPLE CLIPS. ADDITIONAL INFORMATION REGARDING THE OUTCOME HAS BEEN REQUESTED MULTIPLE TIMES WITHOUT RESPONSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16483247 ↗
• InjuryMar 3, 2023Dull, Blunt; Dull, Blunt

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A DISPOSABLE BIOPSY FORCEPS TO OBTAIN A TISSUE SAMPLE DURING ESOPHAGOGASTRODUODENOSCOPY, THE SURGEON COMPLAINED ABOUT THE JAW NOT BEING SHARP. THIS CAUSED A BAD CUTTING BORDER. ADDITIONALLY IT TORE TISSUE AND BLEEDING OCCURRED (STATED TO BE "A FEW"). ADDITIONAL INFORMATION REGARDING INTERVENTIONS AND OUTCOME WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16482176 ↗
• InjuryMar 3, 2023Dull, Blunt; Dull, Blunt

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A DISPOSABLE BIOPSY FORCEPS TO OBTAIN A TISSUE SAMPLE DURING A COLONOSCOPY WITH BIOPSY PROCEDURE, THE SURGEON COMPLAINED ABOUT THE JAW NOT BEING SHARP. THIS CAUSED A BAD CUTTING BORDER. ADDITIONALLY IT TORE TISSUE IN THE SUBMUCOSA IN THE COLON AND BLEEDING OCCURRED. THERE WAS A DELAY OF AN UNKNOWN DURATION THAT OCCURRED WHILE THE SURGEON NEEDED TO OBSERVE THE BLEEDING AREA, BUT NO ADDITIONAL DEVICE WAS NEEDED TO STOP THE BLEEDING. THE AMOUNT OF BLOOD LOSS WAS UNKNOWN. ADDITIONAL INFORMATION REGARDING INTERVENTIONS AND OUTCOME WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16482134 ↗
• InjuryMar 3, 2023Dull, Blunt; Dull, Blunt

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING A DISPOSABLE BIOPSY FORCEPS TO OBTAIN A TISSUE SAMPLE, THE SURGEON COMPLAINED ABOUT THE JAW NOT BEING SHARP. THIS CAUSED A BAD CUTTING BORDER. ADDITIONALLY IT TORE TISSUE AND BLEEDING OCCURRED (STATED TO BE "A FEW"). ADDITIONAL INFORMATION REGARDING INTERVENTIONS AND OUTCOME WAS REQUESTED MULTIPLE TIMES WITHOUT RESPONSE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 16482082 ↗
• InjuryAug 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ACUTE APPENDICITIS AFTER COLORECTAL ENDOSCOPIC MUCOSAL RESECTION: A CASE REPORT". THE CASE REPORT STATED THAT A 62-YEAR-OLD MALE PATIENT WAS ADMITTED, WHO HAD A HISTORY OF MULTIPLE COLONIC POLYPS. THE LARGEST POLYP WAS TREATED BY EMR. THIS WAS FOLLOWED BY THE INJECT AND CUT TECHNIQUE. THE REMAINING FOUR POLYPS WERE REMOVED WITH BIOPSY FORCEPS. THE PATIENT COMPLAINED OF UPPER ABDOMINAL PAIN IN THE EVENING 30 HOURS AFTER COLORECTAL EMR. THE FIRST EMERGENCY COMPUTED TOMOGRAPHY (CT) SCAN WAS SCHEDULED, AND THE RESULTS SHOWED THAT THE APPENDIX WAS SLIGHTLY THICKENED. PATHOLOGICAL ANALYSIS OF THE RESECTED APPENDIX CONFIRMED ACUTE APPENDICITIS. THIS STUDY CONCLUDED THAT FOR PATIENTS WITH PRIOR KNOWN FECALITHS IN THE LUMEN OF THE APPENDIX OR IN THE COLON NEAR THE APPENDIX, THE RISK OF ACUTE APPENDICITIS AFTER EMR COULD BE INCREASED. THUS, COLORECTAL EMR SHOULD BE PERFORMED WITH GREATER CAUTION, AND CAUTIOUS OBSERVATION SHOULD BE PERFORMED AFTER THE OPERATION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: ABDOMINAL PAIN CAUSED BY ACUTE APPENDICITIS - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS F

  Patient problems: Abdominal Pain

  MAUDE report 15257094 ↗