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

Model Number	MDHP100S
Medical Device Problem Codes	Defective Device (2588); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been returned for evaluation/investigation.Therefore, the root cause of the reported phenomenon could not be determined at this time.This report will be supplemented accordingly following investigations.This mdr is being submitted retrospectively as part of a remediation effort related to the recent system and process changes.A capa has been opened to manage the actions related to remediation of this issue and any required reporting.
Event or Problem Description
A report of device stopped working, fault with handpiece during preparation for use was reported.There was no patient involvement, no user injury reported due to the event.This report is related to report patient identifier (b)(6).
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on device return evaluation and the legal manufacturer's investigation.The device was returned and evaluated at oekg olympus united kingdom.Upon evaluation, the device was confirmed for not functioning as expected.Visible inspection noted that the cable was twisted and kinked the whole length, this coincides with the internal resistance of the handpieces being lower than specification allows.It was assumed that the malfunction is caused by broken signal line.The cable consists of multiple signal wires, therefore excessive stress such as twisting and bend causes break of cable.The internal resistance measured 2.884 kohm, below specification for the 5v and ground lines in the mdu cable.There were no other abnormalities noted in the inspection.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product with serial number (b)(6) was manufactured within specification.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 to compress the braiding shield of the wires in the handpiece, which causes shortages in the handpieces.The shortages cause the mdu not to function and or intermittently not to function.This failure has been addressed.Olympus will continue to monitor complaints for 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: 11778430
• Report Number: 1037007-2021-00036
• Device Sequence Number: 3831054
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 00821925027749
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2021

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: MDHP100S
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/15/2021
• Supplement Date Received by Manufacturer: 09/08/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 09/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1