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

Model Number	FB-220U
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Codes	Excessive Tear Production (2235); No Known Impact Or Consequence To Patient (2692)
Date of Event	12/20/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the service center for evaluation.Therefore, the exact cause of the reported event cannot be determined.Upon receipt of the device, an evaluation will be performed and a supplemental report will be submitted.
Event or Problem Description
The service center received a report of four disposable biopsy forceps, model fb-220u, all from the same lot number 97v, that were reported to have dull teeth on the jaws and that did not cut.This is for the fourth set of disposable forceps that did not cut as reported but tore tissue during the procedure.It was reported the forceps were inspected prior to the procedure and no anomalies were observed.A physician was performing a colonoscopy when it was reported the fourth set of forceps used, tore tissue.It was reported the forceps was acting abnormally prior to tearing the tissue but the actual description (i.E.Abnormal behavior) was not provided.It was also indicated it is not known which specific set of forceps tore tissue or if all caused tears during the procedure.The provided information indicated the patient did not incur any blood loss, and the device was used to complete the intended procedure.The patient was discharged as normal with no reported injury.The following devices were used concomitantly during the procedure: olympus cv, clv 190 and pcf190.This is report 4 of 4.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation and correction to the lot number and manufacture date.The user facility returned four sealed unopened boxes, 80 pieces, of fb-220u disposable biopsy forceps, lot number 97v 05, for evaluation of ¿dull teeth which required extra exertion to remove specimen.In addition four forceps were required to complete the procedure.¿ the user¿s complaint was not confirmed.Four disposable biopsy forceps were inspected and tested from the returned lot.A visual inspection on the received condition of the four forceps was unable to verify any of the issues, in regards, to opening and closing of the cups at the distal end.The slider handle was manipulated for each device, to verify the cups at the distal end opened, closed, and was properly aligned.All four forceps were observed to function as intended and confirmed that there was no damage at the distal end.Testing was continued, where the forceps were tested on a sheet of natural rubber latex, and it was noted that each device jaws grasped the sheet as intended, and did not tear through the sheet even when excessive force was applied using the handle.This test was performed with the forceps in the coiled and uncoiled positions.It was observed that a small indent was left upon the latex sheet, however, there were no observations of tearing.Additionally, the insertion portion of each device had no dents or kinks, and the handle portion had no cracks or other abnormalities noted.It was observed that the slider movement was smooth with no restrictions, and the manipulation wire and needle at the distal end of each forceps was neither detached or bent.Concurrently, a device history record (dhr) review was conducted by the original equipment manufacturer (oem) of the relevant production lot and found no problem related to the reported failure.Due to the actual device not being returned, olympus osta was unable to further investigate and determine the root cause of the complaint.

• 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: 9616052
• Report Number: 8010047-2020-00980
• Device Sequence Number: 19513347
• Product Code: FCL
• UDI-Device Identifier: 04953170354120
• UDI-Public: 04953170354120
• Combination Product (Y/N): N
• Initial Reporter State: SC
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/03/2020

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 Expiration Date: 06/30/2024
• Device Model Number: FB-220U
• Device Lot Number: 97V 05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/17/2020
• Supplement Date Received by Manufacturer: 02/05/2020
• Initial Report FDA Received Date: 01/22/2020
• Supplement Report FDA Received Date: 03/03/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: CVCLV 190PCF 190