MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG

Model Number M3-30A

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

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 device distal tip was observed to be burned with loops when performing a bladder tumor removal and transurethral resection of the prostate were performed.The reported issue was found during reprocessing of the device.There was no patient involvement on this report.No known patient injury reported.No user harm reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr).The root cause of the reported issue was not identified.The device was not returned for evaluation.Device history records were reviewed and showed the product met all specifications upon release.Due to no device return, a definitive root cause of the reported complaint cannot be determined at this time.As stated on the ifu (instruction for use) and as a preventive measure, the user manual states: keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active olympus will continue to monitor complaints for this device.

• Brand Name: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Type of Device: M3-GOLD AUTOCLAVABLE FOROBLIQUE TELESCOPE 30 DEG
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10708434
• MDR Text Key: 244129116
• Report Number: 1519132-2020-00091
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• PMA/PMN Number: K890328
• 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: 11/24/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/09/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1