MAUDE Adverse Event Report: GYRUS ACMI, INC MULTIDEBRIDER HANDPIECE, ANGLED; OLYMPUS ENERGY POWER SYSTEM (EPS)

Model Number MDHP100A

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

Patient Problem No Patient Involvement (2645)

Event Date 06/17/2020

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 during preparation for use the device handpiece mdhp100a found no activation.According to the reporter, the burr unit was removed and was reattached however, the issue was not resolved.The device was replaced with another handpiece and no other further details regarding the event was provided.No patient involvement on this event, no user harm or injury was reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the device return evaluation, review of the device history records (dhr) and device evaluation.The device history records for this device were reviewed and all records indicated that the product was manufactured according to all applicable procedures and met final product release criteria.No abnormalities were found.It was reported that during preparation for use the device handpiece mdhp100a found no activation.The mdhp100a was received for the reported issue of not activating.The handpiece was visually inspected.There were no discernible abnormalities found.In addition, functional testing was performed.The handpiece passed all functional tests, the service team was unable to duplicate the user reported failure.Due to no damages confirmed, a root cause could not be identified.Olympus will continue to monitor complaints for this device.

• Brand Name: MULTIDEBRIDER HANDPIECE, ANGLED
• Type of Device: OLYMPUS ENERGY POWER SYSTEM (EPS)
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10267934
• MDR Text Key: 201544589
• Report Number: 1037007-2020-00020
• Device Sequence Number: 1
• Product Code: GIE
• 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,health
• Type of Report: Initial,Followup
• Report Date: 08/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/13/2020
• 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: 07/12/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1