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

Model Number MDHP100A

Device Problem Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Date 12/10/2020

Event Type  malfunction  

Manufacturer Narrative

Device was evaluated.Evaluation confirmed the reported issue.The device during testing failed the resistance testing (out of range) with error message.In addition, minor scratches on the housing were determined.Investigation is ongoing therefore the root cause cannot be determined at this time.If additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported that the device handpiece was not functioning as intended.The diego device was showing alarm saying reboot system with handpiece, however, when tested with another handpiece, the diego device did work with no issue.The issue occurred during preparation for use.There was no patient involvement reported.No user injury reported.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response and updates.The following sections were updated: b3, g4, g7, h2, h6 and h10.Further communication with the customer conveyed the following information: the date the issue occurred was on (b)(6) 2020.The intended procedure was able to be completed.There was no patient injury, infection or medical intervention required the model of the device used to complete the procedure was mdfp100a.The serial/lot number was unable to be provided.The device was inspected prior to use.There was no damage or abnormalities observed.The settings on the generator are unknown.The settings on the generator is assumed they were correct as surgery was completed with another handpiece.The connection between the cord and equipment was secure.The error said "reboot" there was no code that appeared.

Manufacturer Narrative

This report is being supplemented to inform that upon further review this is not a reportable malfunction.Per the legal manufacturer there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.The following sections were updated: g4, g7, h2 and h10.

• 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: 11157747
• MDR Text Key: 228350146
• Report Number: 1037007-2021-00006
• 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,Followup
• Report Date: 02/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: MDHP100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1