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

Model Number	FB-211D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/31/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to service center for a evaluation and the user's complaint was confirmed.A visual inspection was performed on the returned device and found the manipulation wire that controls the movement of the forcep jaws is broken/spilt in half.There is sufficient amount of rust on the surface base of the forcep jaws, which most probable cause the manipulation wire to break off.There was no other damage noted with device.Based on the evaluation the cause of the broken manipulation wire and rusted distal end base jaw is due to mishandling.
Event or Problem Description
Service center was informed that during a biopsy, the forceps were removed, and malfunctioned upon depositing the biopsy in a specimen cup.A new set of forceps was used for additional biopsies and the procedure was concluded without any complications.There were no patient injury reported.

• 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
• MDR Report Key: 8790952
• Report Number: 8010047-2019-02533
• Device Sequence Number: 1845580
• Product Code: EOQ
• UDI-Device Identifier: 04953170389535
• UDI-Public: 04953170389535
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K950636
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/15/2019

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-211D
• Device Lot Number: 88V-31
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/20/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2019
• Initial Report FDA Received Date: 07/15/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1