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

Model Number	FB-220U
Medical Device Problem Codes	Mechanical Problem (1384); Failure to Cut (2587)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Thirty-one pieces of brand new and sealed fb-220u biopsy forceps (lot#95v 25) were received for evaluation due to ¿does not cut¿ issue.Visual inspection was performed on the received condition on 5 of the 31 biopsy forceps and no issues found on the device.The jaws were manipulated and the movement is found normal.During manipulation process the wire was coiled and the movement is consistent and smooth.The insertion portion was checked and did not find any external damages.The handle was manipulated and the movement is smooth.The needle at the distal end tip was inspected and did not find any evidence of damage.Dental dam was used to test the integrity of the jaws biting down and observed the jaws grasping normal.Based on the evaluation, the reported issue was not able to be confirmed as the device operates normally with no signs of abnormalities observed.
Event or Problem Description
Eleven facility physicians state while using the fb-220u, the cut is not as smooth as expected.It was cutting but it felt more like a tear than a smooth cut.There was no patient injury or death due to this issue.No patient information provided.It was reported that no uncontrolled bleeding occurred, no injuries or no medical intervention was necessary.The procedures where the device was used were esophagogastroduodenoscopy (egd) and colonoscopy.Procedures were completed with the same biopsy forceps.Physicians are experienced using the device.Report 1 of 11.

• 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: 9612233
• Report Number: 8010047-2020-00959
• Device Sequence Number: 13584224
• Product Code: FCL
• UDI-Device Identifier: 04953170354120
• UDI-Public: 04953170354120
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 01/21/2020

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: 95V 25
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/27/2019
• Initial Report FDA Received Date: 01/21/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1