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
The returned device was evaluated.The reported issue was confirmed.Functional testing found the breakout box tests failed, the unit was found to have shorted between phase-gnd, resulting in intermittent device usability.The definitive root cause of the failure mode was identified as a short between phase-gnd, which results in handpiece not recognized by console.The device history records 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.Review of manufacturing functional checklist, the handpiece was found to pass all functional tests, such as sequence 11, which requires proper motor activation for 10 seconds.It is unlikely that the handpiece left the facility with damages resulting in failure to recognize handpiece.This suggests the damages found were as a result of transportation or use.Per the instruction for use, the handpiece should be handled carefully.It should be carefully inserted and withdrawn from the patient, prolonged activation should be avoided where possible, and the handpiece should not be activated while adjacent to metallic objects.Olympus will continue to monitor complaints for this device.
Event or Problem Description
Device not functioning as intended, comes up with error code asking to reinsert the handpiece during preparation for use was reported.There was no patient involvement, no user injury reported due to the event.

• 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: 11811652
• Report Number: 1037007-2021-00039
• Device Sequence Number: 3747891
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 00821925027749
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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): 05/12/2021

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: 04/23/2021
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/16/2021
• Initial Report FDA Received Date: 05/12/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1