MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER HANDPIECE, ANGLED

Model Number	MDHP100A
Medical Device Problem Code	No Device Output (1435)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The service team received a mdhp100a for the reported issue of "not recognized by the customer's console".As a part of the estimation process, the handpiece underwent a visual inspection.There were no abnormalities discovered aside from minor scratches on the housing.Furthermore, the handpiece also underwent functional testing to assess the device status.The user request could not be confirmed, the handpiece passed all functional tests and was able to be recognized by the test console.The definitive root cause of the handpiece not being recognized by console could not be determined.Though no damages were found, the handpiece was connected to a test console for activation in sequence 10.As a result, it was unlikely that any internal damage occurred in transport that have contributed to the handpiece recognition issue reported by the customer.The minor damages noted on the handpiece were likely as a result of transportation or use.Olympus will continue to monitor complaints for this device through regular trending activities.
Event or Problem Description
The user facility reported that the handpiece was not recognized by either console.There was no patient involvement reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the legal manufacturer investigation and additional information from the customer.Additional information from customer states the event occurred during a diagnostic fess procedure.Midway through case, console said blade was disconnected and stopped working.Turned off and turned back on, the console didn¿t recognize the handpiece or footpedal.Blade model sb4000sc.There was no damage noted with the burr or blade.There were no alarm, alerts or error codes noted.The hand-piece become hot.Another console and hand pieces was used to complete the procedure.There was no tissue trauma or additional bleeding because of the event.There was no injury or additional treatment required.In addition, the legal manufacturer reported dhrs for this product have been reviewed.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.A total of 5 units were produced under this job number with no associated ncrs, reported scrap, or recorded process deviations relating to the reported failure.

• Brand Name: MULTIDEBRIDER HANDPIECE, ANGLED
• Common Device Name: MULTIDEBRIDER HANDPIECE, ANGLED
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11612795
• Report Number: 1037007-2021-00026
• Device Sequence Number: 16918874
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 0100821925027749
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K123429
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2021

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: MDHP100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/11/2021
• Supplement Date Received by Manufacturer: 04/05/2021
• Initial Report FDA Received Date: 04/05/2021
• Supplement Report FDA Received Date: 04/28/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1