MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG

Model Number M3-0A

Device Problems Break (1069); Dent in Material (2526)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Event Description

As reported, during reprocessing of the device, sharp distal tip was observed.There is no patient involvement on this reported event.No user injury reported.

Manufacturer Narrative

The subject device was received and evaluated.Inspection found fiber breakage and dent on edge.The reported issue of sharp distal tip was confirmed.Furthermore, the optical fiber image was observed to be out of field of view and severe debris was observed.The e/p cup was found dented.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's investigation.Device history records were reviewed and showed the product met all specifications upon release.Based on the device inspection results, physical damage which occurred to the device was most likely due to user mishandling.The device ifu (instruction for use) states : study this manual and other labeling thoroughly for safe handling and storage.Misuse of instruments can cause injury to the patient and could have an adverse effect on the procedure being performed.Do not drop instruments or allow them to be struck by other objects.Olympus will continue to monitor the field performance of this device.

• Brand Name: M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG
• Type of Device: M3-GOLD AUTOCLAVABLE DIRECT TELESCOPE 0 DEG
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12492791
• MDR Text Key: 283506725
• Report Number: 1519132-2021-00017
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925005648
• UDI-Public: 00821925005648
• 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: 10/04/2021

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: M3-0A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2021
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 08/30/2021
• Initial Date FDA Received: 09/17/2021
• Supplement Dates Manufacturer Received: 09/28/2021
• Supplement Dates FDA Received: 10/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1