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

Model Number	FB-231D
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/07/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device was returned to olympus medical systems corp.(omsc) for evaluation.In the evaluation of omsc the following was confirmed, the lot number was 19k with supplementary information number of "29".The cup could not be opened or closed.Two control wires had come loose from the control wire fixing holes in the cup.The two control wires were broken and there were missing parts.The fixing hole of the control wire on the cup was scratched by the excessive force of the control wire.There were no abnormalities such as buckling of the insertion part.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.
Event or Problem Description
Olympus medical systems corp.(omsc) was informed from user facility that the cup was opened.And the subject device was pointed out that the joint (hinge part) of the cup was broken and one of the cups opened too much.The intended procedure was completed with another device.The subject device was returned to omsc for evaluation.Omsc confirmed the following event on (b)(6) 2022 and determined that it was an medical device report (mdr) reportable event.The two control wires were broken and there were missing parts.There was no report of patient injury associated with the event.
Additional Manufacturer Narrative
Correction to g3 of the initial medwatch.The aware date should be 07-jan-2022.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: 13486922
• Report Number: 8010047-2022-02616
• Device Sequence Number: 5247610
• Product Code: EOQ
• UDI-Device Identifier: 04953170158209
• UDI-Public: 04953170158209
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K950636
• 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,Distributor
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 12/12/2022

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-231D
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• 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: 01/18/2022
• Supplement Date Received by Manufacturer: 11/08/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 12/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown