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

Model Number	MDHP100A
Medical Device Problem Code	Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection found the device failed the gnd-a, gnd-b, and gnd-c breakout box test, the handpiece was found faulty.The reported issue was confirmed.The definitive root cause was confirmed to be as a result of the failed gnd-phase breakout box test.The result of this damage is the handpiece working intermittently.The device history records (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.Per the device functional checklist, the handpiece must undergo an activation test with the appropriate console and accessories prior to being shipped out.Therefore, it is improbable for the handpiece to be shipped out to the customer with a known activation/recognition issue.The damages incurred were likely as a result of transportation or customer use.Olympus will continue to monitor complaints for this device through regular trending activities.
Event or Problem Description
Communication error with hand piece was reported.The issue occurred during preparation for use.There was no patient involvement, no user injury reported.

• 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: 11689371
• Report Number: 1037007-2021-00027
• Device Sequence Number: 11545229
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 0100821925027749
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/19/2021

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: 03/24/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/24/2021
• Initial Report FDA Received Date: 04/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1