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

Model Number	MDHP100A
Medical Device Problem Codes	Defective Device (2588); Output Problem (3005)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/14/2021
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 the legal manufacturer's investigation.The subject device was returned, upon evaluation it was found that the cable was twisted and kinked of the whole length.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 original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.This product with serial number 051839 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.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: 11778455
• Report Number: 1037007-2021-00037
• Device Sequence Number: 17101503
• 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): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 09/02/2021

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: 08/17/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 03/14/2021
• Supplement Date Received by Manufacturer: 09/01/2021
• Initial Report FDA Received Date: 05/05/2021
• Supplement Report FDA Received Date: 09/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1