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

Model Number	FB-220U
Medical Device Problem Codes	Dull, Blunt (2407); Failure to Cut (2587)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/13/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has not been returned to the service center for evaluation as it has been reported to have been discarded by the user facility.Therefore, an exact cause for the reported event cannot be determined.Upon return of the device, by chance, a full evaluation will be completed and a supplemental report will be submitted.
Event or Problem Description
The service center received a report of seven separate disposable biopsy forceps (model fb-220u), lot number 97v, that did not perform as expected, not cutting well during procedures.This is for the third set of biopsy forceps that did not cut well for a physician during an unspecified procedure.The biopsy forceps were inspected upon opening of the package and no abnormalities were observed.The physician proceeded with the intended procedure and it was reported the device did tear tissue.It was reported there was no blood loss.The device was disposed of at the successful completion of the surgery.It was reported there was no patient death or injury and the patient was discharged to home as normal.This is report 3 of 7.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the device evaluation, complete lot number, manufacture date and additional information from the original equipment manufacturer (oem).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.Eighty-one sealed and unopened disposable biopsy forceps, fb-220u, all from the same lot 97v 29, were received at the service center for the evaluation for ¿not cutting as well as other lots¿.Four biopsy forceps from the lot returned were visually inspected by manipulating the slider handle, and it was verified that the cups at the distal end of the device had no problem in opening, closing, and aligning properly.It was further observed that the distal end of each device was neither bent nor damaged.The forceps were tested on a sheet of natural rubber latex and it was noted that the jaws grasped the sheet rather than tearing through it, even when excessive force was applied with the handle.This test was performed with the forceps in the coiled and uncoiled position.An observation was made that a small indentation was left on the sheet of rubber latex, however, there was no signs of tearing.Additionally, it was observed that each device¿s insertion portion had no dents or kinks, and the handle section had no cracks or other abnormalities.It was noted that the slider movement for each device was smooth with no restrictions, and the manipulation wire and needle at the distal end was neither bent nor detached.Based upon the evaluation of the returned samples of disposable biopsy forceps, fb-220u, the user¿s complaint could not be confirmed, as there were no issues noted for the cups at the distal end of the device.

• 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: 9673661
• Report Number: 8010047-2020-01157
• Device Sequence Number: 401276
• 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): 03/20/2020

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 Model Number: FB-220U
• Device Lot Number: 97V 29
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 01/13/2020
• Supplement Date Received by Manufacturer: 03/03/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 03/20/2020
• 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: OLYMPUS CLV 190; OLYMPUS CV; OLYMPUS PCF 190