MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. DISPOSABLE BIOPSY FORCEPS

Model Number	FB-210K
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	11/02/2020
Type of Reportable Event	Serious Injury
Event or Problem Description
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 obtained from the margins of the post-polypectomy defect to confirm complete resection.Surveillance colonoscopy was performed to screen for local recurrence results: all lesions were successfully resected using csp without submucosal injection.The median diameter of the resected lesions was 14 mm, and pcsp was used to resect 106 (22%) lesions.Post-polypectomy biopsies revealed residual serrated tissue in only one case (0.2%).Adverse events included immediate bleeding in 8 (3%) patients; no delayed bleeding events occurred, irrespective of the use of antithrombotic drugs.During a 7-month median follow-up period, surveillance colonoscopies were performed for 384 lesions (81%), and no local recurrences were detected.Conclusion: csp without submucosal injection is a safe and effective treatment for ssls =10 mm.Although ipb occurred in 8 (3%) patients, it was successfully managed by clipping.Dppb did not occur in any of the cases despite the enrollment of 35 patients receiving antithrombotic therapy (an antiplatelet agent in 22 patients, an anticoagulant in 9 patients, and both in 4 patients).No other adverse events, including perforation or post-polypectomy syndrome, occurred.There is no report of olympus device malfunction described in this study.
Additional Manufacturer Narrative
This report is being submitted to provide information described in the literature and investigation findings.The device referenced in this report was not returned to olympus for physical evaluation.There was no report of olympus device malfunction described in this literature.The lot number was not provided; therefore, a device history record could not be reviewed.It should be noted however, olympus does not ship any device that doesn¿t meet all design and safety specifications.The definitive cause of the reproted event could not be conclusively identified.

• Brand Name: DISPOSABLE BIOPSY FORCEPS
• Common Device Name: DISPOSABLE BIOPSY FORCEPS
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 14269565
• Report Number: 8010047-2022-07415
• Device Sequence Number: 14562561
• Product Code: FCL
• UDI-Device Identifier: 04953170031007
• UDI-Public: 04953170031007
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Study,Literature,Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: FB-210K
• Device Lot Number: UNKNOWN(LITERATURE)
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/03/2022
• Initial Report FDA Received Date: 05/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other
• Patient Sex: Unknown