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.Inspection found the reported issue was not able to be duplicated however, cut on the cable cord was observed.There were no other abnormalities found during inspection.The original equipment manufacturer (oem) performed a service history record review and no abnormalities were noted.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for the reported phenomenon.The root cause has been determined to be use error.As the device passed all functional checks during the evaluation and the customer phenomenon could not be duplicated, it is unlikely the unit left the facility damaged.Therefore, the damages incurred may have been a result of usage.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
A report of handpiece not functioning as intended, not identifying on console 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: 11779992
• Report Number: 1037007-2021-00038
• Device Sequence Number: 14410710
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 00821925027749
• 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): 05/05/2021

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