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

Model Number	FB-230K
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/03/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Multiple follow-ups were made to the user facility via telephone and in writing to obtain additional information regarding the reported event but with no results.The referenced device was not returned to the manufacturer for evaluation.Therefore, the exact cause of the reported event could not be conclusively determined at this time.However, if additional information becomes available or if the device is returned for evaluation at a later date, this report will be supplemented accordingly.As a preventive measure, the instruction manual provides warning which states, 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 irregularity.The breakage of the distal end such as the operation wire¿s detachment could cause mucous membrane damages and to always have a spare instrument available.Also, to perform an appearance inspection (i.E.While operating the slider to open and close the cups, confirm that the instrument has no disconnected or loose parts, make sure that the cups close evenly and are properly aligned when the slider is pulled, confirm that there are no sharp protrusions, burrs, or edges on the distal end of the insertion portion).
Event or Problem Description
The user facility reported that during a diagnostic gastroscopy procedure that once the device was withdrawn from the gastroscope, the mucosa sample was reportedly observed to be torn off and did not fit inside the cup of the forceps.The piece of mucous fell into the patient's intestine.There was no patient injury reported.The intended procedure was completed with a similar device (from different lot #, 87v).No other equipment was replaced during procedure.The user facility reported this problem has occurred with other forceps from the same lot number and with three different surgeons.This is for report 3 of 3.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation results.The device, lot# 86v 29, was received in the original packaging, which was unopened upon receipt.A visual inspection was performed on the returned device and was unable to confirm any issues related to the reported event.The slider handle was manipulated and noted the cups at the distal end of the device opened, closed, and properly aligned without issue.The distal end of the device is not bent or damaged.The grasping function of the forceps was tested on a lemon and the cups at the distal end were able to remove a piece of the lemon without any issues or concerns.Additionally, the insertion portion has no dents or kinks, and the handle section has no cracks or other abnormalities.The slider movement is smooth with no restrictions and the manipulation wire and needle at the distal end are not detached or bent.Based on the evaluation, the reported event could not be confirmed as the device passed inspection, tested, and functioned appropriately.The instructions for use (ifu) states the following, ¿if you press the instrument¿s distal end too hard against the tissue in an attempt to take a sample more than needed, the risk of perforation increase.Do not take more than needed.¿.

• 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: 8670173
• Report Number: 2951238-2019-00910
• Device Sequence Number: 2182528
• Product Code: FCL
• UDI-Device Identifier: 04953170354090
• UDI-Public: 04953170354090
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2019

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 Expiration Date: 05/31/2023
• Device Model Number: FB-230K
• Device Lot Number: 86V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 05/06/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 06/05/2019
• Supplement Report FDA Received Date: 07/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1