MAUDE Adverse Event Report: GYRUS ACMI, INC MINI MCGEE ALLIG FORC STR, SERRD

Model Number 131040

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/04/2019

Event Type  malfunction  

Manufacturer Narrative

The device was returned to the service center and is pending evaluation.The cause of the reported event cannot be determined at this time.

Event Description

The user facility reported that during the middle of a therapeutic canaloplasty procedure, the instrument would not close during use and one of the points was bent and broke off upon removal from the patient¿s ear.The doctor was removing tissue during the procedure when the event occurred.The intended procedure was completed with a different less preferred instrument.No additional treatment was required.There was no patient injury reported.

Manufacturer Narrative

This supplemental report is being submitted to report the device evaluation results, and provide additional information.The device was returned to the service center for evaluation.The instrument was visually evaluated and the reported broken off point was consistent with customer complaint.However, could not duplicate the reported complaint of the instrument not closing.The device was mechanically tested and the instrument was able to open/close with no restriction observed.Based on the evaluation findings, the instrument mechanically operates as intended.As a part of remediation action, a dhr review was performed for the finished device and found 1 reject detected during production.

• Brand Name: MINI MCGEE ALLIG FORC STR, SERRD
• Type of Device: MINI MCGEE ALLIG FORC STR
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 8955150
• MDR Text Key: 160132003
• Report Number: 2951238-2019-01092
• Device Sequence Number: 1
• Product Code: LRC
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 10/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 131040
• Device Lot Number: SD691048
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1