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

Model Number	FB-225U
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	Tissue Damage (2104)
Date of Event	07/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The referenced device was not returned to service center for an evaluation.The cause of the reported complaint cannot be confirmed.As a preventive measure against breakage, the device instructions manual cautions, "if you use the instrument several times during one procedure, confirm that there is no irregularity with its operation and appearance, each time you use it.Do not use the instrument if you detect any abnormality and never use excessive force to open or close the cups.This could damage the instrument.The instructions manual also has directions for pre-procedure inspection of the device, including tactile inspection of the insertion portion, and verification of device operation.The instructions manual warns that during the procedure, do not insert the instrument into the endoscope while the cups are open, do not force the instrument if resistance to insertion is encountered.Reduce the endoscope's angulation (or lower the forceps elevator if applicable) until the instrument passes smoothly and do not withdraw the instrument from the endoscope while the cups are open.To avoid procedure interruption, the instructions manual also recommends, always have a spare instrument available.".
Event or Problem Description
The service center was informed that while using the device, the teeth on the jaws were not sharp and were tearing the mucosa instead of cutting it.There was no patient injury reported.

• 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: 8894826
• Report Number: 8010047-2019-02940
• Device Sequence Number: 19222833
• Product Code: FCL
• UDI-Device Identifier: 04953170408274
• UDI-Public: 04953170408274
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 08/14/2019

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-225U
• Device Lot Number: 91V
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1