DISPOSABLE BIOPSY FORCEPS FB-210KRecalls & reported problems
Olympus Medical Systems Corp. · DISPOSABLE BIOPSY FORCEPS · Class 1
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04953170031007), received between May 3, 2022 and May 3, 2022 — classified as 1 injury.
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
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Hemorrhage/Blood Loss/Bleeding1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 3, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IN THE LITERATURE TITLED ¿SAFETY AND EFFICACY OF COLD SNARE POLYPECTOMY WITHOUT SUBMUCOSAL INJECTION FOR LARGE SESSILE SERRATED LESIONS: A PROSPECTIVE STUDY,¿ PATIENTS EXPERIENCED IMMEDIATE POST-POLYPECTOMY BLEEDING DURING COLD SNARE POLYPECTOMY (CSP) PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS FB-210K USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AZI USED IN THE PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H290ZI USED IN THE PROCEDURES. STUDY BACKGROUND/AIM: COLD SNARE POLYPECTOMY (CSP) HAS BECOME THE STANDARD RESECTION METHOD FOR SMALL COLORECTAL POLYPS (<10 MM). SESSILE SERRATED LESIONS (SSL) HAVE LOW PREVALENCE OF ADVANCED HISTOLOGY IRRESPECTIVE OF SIZE, AND THUS COULD BE AMENABLE TO CSP. THIS STUDY EVALUATED THE SAFETY AND EFFICACY OF CSP FOR SSLS =10 MM. METHODS: BETWEEN NOVEMBER 2018 AND JANUARY 2020, WE PROSPECTIVELY ENROLLED 300 CONSECUTIVE PATIENTS WHO UNDERWENT CSP FOR 474 SSLS =10 MM. TO DELINEATE SSL BORDERS, INDIGO CARMINE CHROMOENDOSCOPY AND/OR IMAGE-ENHANCED ENDOSCOPY WAS CONDUCTED. PIECEMEAL CSP (PCSP) WAS PERFORMED IN CASES WHERE EN-BLOC RESECTION WAS DIFFICULT. BIOPSY SPECIMENS WERE OB
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 14269565 ↗
Other FORCEPS, BIOPSY, NON-ELECTRIC devices
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- Radial Jaw 4 M00513330Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall19 reports
- Radial Jaw 4 M00513400Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall16 reports
- NA 8736685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall15 reports
- NA 828051Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall6 reports
- Radial Jaw 4 M00513320Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall3 reports
- Radial Jaw 4 M00513360Boston Scientific Corporation · FORCEPS, BIOPSY, NON-ELECTRIC1 recall2 reports
- NA 8735685Richard Wolf GmbH · FORCEPS, BIOPSY, NON-ELECTRIC1 recall1 report
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.