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

Model Number MDHP100A

Device Problems No Device Output (1435); Defective Device (2588)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the handpiece is not functioning as intended.The device showed error message ¿e12 error¿.The issue occurred during an unspecified procedure.There was no patient harm or injury reported.No user injury reported.

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 device history record review and no abnormalities were noted.The device was not returned for physical evaluation, however an investigation was completed by the oem and determine that the root cause of the failure reported can be attributed to a short circuit in the handpiece cable.Olympus will continue to monitor the field performance of this device.

• Brand Name: MULTIDEBRIDER HANDPIECE, ANGLED
• Type of Device: MULTIDEBRIDER HANDPIECE, ANGLED
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 11440219
• MDR Text Key: 238922176
• Report Number: 1037007-2021-00024
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 00821925027749
• Combination Product (y/n): N
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDHP100A
• Device Catalogue Number: MDHP100A
• Device Lot Number: AV864322
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1