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

Model Number MDHP100A

Device Problems Defective Device (2588); Output Problem (3005)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The device was returned and evaluated.Evaluation of the device was found to be functional and the customer reported issue could not be duplicated, the complaint was not confirmed.The original equipment manufacturer (oem) performed a device history record review and no abnormalities were noted.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.The root cause has been determined to be customer usage.Due to device having passed all functional tests and having no visual abnormalities, evidence of device being inspected by manufacturing prior to being shipped to the customer confirmed by dhr evaluation, it is unlikely the unit left the facility damaged.Therefore, the malfunction incurred may have been a result of the use of the device.Olympus will continue to monitor complaints for this device.

Event Description

It was reported that during preparation for use the device was found not recognizing the handpiece.There was no patient involvement on this event reported.No user injury reported.

• Brand Name: MULTIDEBRIDER HANDPIECE, ANGLED
• Type of Device: MULTIDEBRIDER HANDPIECE, ANGLED
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• Manufacturer Contact: kenneth pittman ; 2925 appling rd; bartlett, TN 38133 ; 9013785969
• MDR Report Key: 11149064
• MDR Text Key: 228350148
• Report Number: 1037007-2021-00005
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00821925027749
• UDI-Public: 00821925027749
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K123429
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/11/2021

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
• Device Operator: Health Professional
• Device Model Number: MDHP100A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/14/2020
• Initial Date FDA Received: 01/11/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2018
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1