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

Model Number	FB-225U
Medical Device Problem Codes	Device Reprocessing Problem (1091); Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device referenced in this report has been returned to olympus for evaluation.The investigation is in progress.The definitive cause for the customer's experience can not be determined at this time.This report will be updated upon completion of the investigation or if additional relevant information is provided.
Event or Problem Description
It is reported after completing a diagnostic gastroscopy using an olympus forceps and an olympus scope (documented in report with patient identifier (b)(6)) a leak test was performed on the on the scope and it came back positive.There was no patient affected by this event.
Event or Problem Description
Additional information provided by the customer: there was no positive leak/culture related to this event.
Additional Manufacturer Narrative
This report is being updated to report new information provided by the customer (b5,) and corrected information (b1, h1, h6-device code, results code, and h10).B1-there is no reportable product problem.H1-there is no reportable device malfunction.Based on additional information provided by the customer, this case has been determined to be a non-reportable device malfunction.

• Brand Name: SINGLE USE 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
• MDR Report Key: 10859941
• Report Number: 8010047-2020-09035
• Device Sequence Number: 19463343
• Product Code: FCL
• UDI-Device Identifier: 04953170408274
• UDI-Public: 04953170408274
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: CLASS1-EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: FB-225U
• Device Lot Number: 9XV
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/21/2020
• Supplement Date Received by Manufacturer: 12/02/2020
• Initial Report FDA Received Date: 11/18/2020
• Supplement Report FDA Received Date: 12/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1