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

Model Number	FB-225U
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As part of our investigation, olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event but with no result.Therefore; was unable to confirm if excessive bleeding or patient impact occurred.The device was not returned to the service center for evaluation.However, 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.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.Do not withdraw the instrument from the endoscope while the cups are open.¿ this report is being filed in abundance of caution.
Event or Problem Description
The service center was informed that the customer reported that excessive bleeding maybe caused due to the deep bite of these forceps.There was no patient injury reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to report the device evaluation results, update the lot number and manufacturer date.The customer returned 3 boxes of brand new and sealed fb-225u forceps (lot#: 93v19) for evaluation due to ¿deep bites on forceps.¿ the users complaint was not confirmed.The devices were returned in its original package.A visual inspection was performed on the received condition of 6 forceps and did not find any problems with the forceps.The insertion portion was inspected and did not find any kind of external damages.The jaws were observed and the open and close movement is consistent and normal.The forceps were coiled and manipulated; the movement of the jaws continued to be normal.The slider was manipulated and the movement is consistent and smooth.Dental dam was used to check the integrity of the biting down function and the biting function is normal.Based on the evaluation, the users complaint could not be confirmed as the forceps operated as normal with no signs of abnormalities.

• 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: 9157383
• Report Number: 8010047-2019-03499
• Device Sequence Number: 2151751
• Product Code: FCL
• UDI-Device Identifier: 04953170398858
• UDI-Public: 04953170398858
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: EXMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/31/2019

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: 93V 19
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/27/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 09/10/2019
• Supplement Date Received by Manufacturer: 10/10/2019
• Initial Report FDA Received Date: 10/04/2019
• Supplement Report FDA Received Date: 10/31/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1