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

Model Number	FB-240U
Medical Device Problem Codes	Device Damaged Prior to Receipt by User (1570); Device Damaged Prior to Use (2284)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/16/2021
Type of Reportable Event	Malfunction
Event or Problem Description
As reported, handpieces smashed during shipping.Outer box damaged.Something fell on top of the box containing the fb-240u units and damaged three pieces where they were sticking out of the sterile packaging.There is no patient involvement on this reported event.Device return evaluation found 3 devices had holes on the front of the packaging exposing the instrument.This report is related to reports with patient identifier (b)(6).
Additional Manufacturer Narrative
The customer returned a total of 20 disposable forceps.Three open and seventeen unopened disposable biopsy forceps model number fb-240u lot number 13v 26 in for evaluation for ¿out of box failure¿.Device inspection found the reported issue of "out of box" failure was confirmed.Visual inspection on the ¿as received¿ condition performed.All forceps were received in the original packaging, however the original shipping box was not returned.Three out of the twenty devices had holes on the front of the packing exposing the instrument.The content (disposable forceps) inside was removed and evaluated.The jaws had the brown protector boot still attached and under the microscope did not appear to have any foreign material, which would indicate the device has not been used.A functional check was also performed and there were no abnormalities detected.The dhr (device history record) with the lot number of the subject device was confirmed and reviewed.No abnormalities detected in the dhr for the following items which related to the reported phenomenon.-process inspection sheet -quality inspection sheet -nonconforming product report investigation is still ongoing.This report will be supplemented accordingly following investigation.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to g3.Correction to g3 of the initial medwatch.The aware date should be (b)(6) 2021.Based on the results of the investigation, the specific root cause of the damaged devices from shipping could not be determined at this time.Olympus will continue to monitor field performance for this device.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 12817193
• Report Number: 8010047-2021-14564
• Device Sequence Number: 5696237
• Product Code: FCL
• UDI-Device Identifier: 04953170354144
• UDI-Public: 04953170354144
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K955065
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/26/2022

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-240U
• Device Lot Number: 13V 26
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2021
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 03/28/2022
• Initial Report FDA Received Date: 11/15/2021
• Supplement Report FDA Received Date: 04/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/25/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown