MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. FG HANDLE

Model Number	MA-479
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The root cause cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
A distributor, on behalf of a user facility, reported to olympus that during a polypectomy the fg handle failed.It was stated that the ¿endo-looping application equipment crashed.¿ initial information indicated that the procedure was altered.Additional information clarified that the procedure was converted to surgery.It was stated that there was no damage or bleeding of the patient.Additional event and outcome information has been requested.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide additional information obtained from the customer regarding the reported event.New information added to the following fields: a3, b2, b5, b7 and h6.
Event or Problem Description
Additional information from the user facility reported that the surgical conversion procedure was laparoscopic and approximately three hours in length.The polyp was successfully removed.The patient was admitted for one day, but was stated to be in perfect health post polypectomy.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, since the device could not be confirmed and details regarding the reported incident were not provided, the root cause of the event could not be determined.This supplemental report includes a correction to e3 to provide information that was inadvertently not included in the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: FG HANDLE
• Common Device Name: HANDLE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16219591
• Report Number: 9614641-2023-00097
• Device Sequence Number: 15342017
• Product Code: MND
• UDI-Device Identifier: 04953170032554
• UDI-Public: 04953170032554
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K984255
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MA-479
• Device Lot Number: 0XK
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/26/2022
• Supplement Date Received by Manufacturer: 01/31/2023; 05/18/2023
• Initial Report FDA Received Date: 01/20/2023
• Supplement Report FDA Received Date: 02/09/2023; 05/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Sex: Male