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)
Date of Event	02/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device was evaluated.Inspection determined that the unit failed the gnd to phase test (shorted) and found no output.The device is non repairable.The investigation is ongoing; therefore, the root cause of the reported failure cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.
Event or Problem Description
It was reported that at the beginning of an unspecified procedure, the handpiece was not functioning as intended.The system was not reading the unit.It was suspected that something maybe wrong with the electrical circuit.The intended procedure was completed using similar device.Serial number used was not provided.There was no patient harm on the reported event.No user injury reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The original equipment manufacturer (oem) performed a review of the device history record and found no deviations that could have caused or contributed to the reported issue.All records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.An investigation was completed by the oem and determined that there is no manufacturing nor processing related cause for this failure mode.Olympus will continue to monitor the field performance of this device.

• 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: 11372404
• Report Number: 1037007-2021-00023
• Device Sequence Number: 3781959
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 00821925027749
• Combination Product (Y/N): N
• Initial Reporter State: CT
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/16/2021

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
• Device Catalogue Number: MDP100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/02/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 02/02/2021
• Supplement Date Received by Manufacturer: 03/02/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 03/16/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1