MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER HANDPIECE, ANGLED; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	MDHP100A
Medical Device Problem Code	Communication or Transmission Problem (2896)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Additional information is not yet available for this event.Event date is not known.The device is returned but the device evaluation is not yet completed.As such a definitive root cause of the reported complaint cannot be determined at this time.Supplemental report(s) will be filed as the information becomes available.
Event or Problem Description
As reported for this event, during preparation for use the console did not identify the device.There is no patient involvement and no harm reported to any patient.
Additional Manufacturer Narrative
Evaluation is now completed for the device.This supplemental report is being submitted to provide this information.Upon evaluation of the returned device, the device was noted to have normal wear and tear from usage.There were no other abnormalities noted in the inspection.The device failed the breakout box test for ground phase a, b, and c.This caused the user issue of the hand piece not being identified on the console.The original equipment manufacturer (oem) performed a service history record review and no abnormalities were noted.This product with serial (b)(6) passed all testing and the customer phenomenon was not confirmed in the review.An investigation was completed by the oem and determined that there is no manufacturing nor processing related cause for this failure mode.The root cause has been determined to be material used in the cable production of the handpiece.Motor phase wires in the cable are compressed with braided shield resulting in insulation damage and shorting of the conductors to ground.The corrective action for the motor phase wire short was to redesign the cable of the handpiece, which has passed the verification of effectiveness.Olympus will continue to monitor the field performance of this device.This device is non-repairable.

• Brand Name: MULTIDEBRIDER HANDPIECE, ANGLED
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11706302
• Report Number: 1037007-2021-00028
• Device Sequence Number: 17117305
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/18/2021

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: No Information
• 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
• Initial Date Received by Manufacturer: 03/30/2021
• Supplement Date Received by Manufacturer: 04/29/2021
• Initial Report FDA Received Date: 04/22/2021
• Supplement Report FDA Received Date: 05/18/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1