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

Device evaluation confirmed the reported issue.The meniscus at distal tip was touching the cover glass and was damaged.The light fibers were found broken.The damages observed caused debris on the undercover glass and resulted in poor image.The damages found on the device were most likely caused by user mishandling.Device history records were reviewed and showed the product met all specifications upon release.As stated on the ifu (instruction for use) and as a preventive measure, 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 complaints for this device.

Event Description

It was reported that the device was found with bent tip and sharp edges, sharp burr on the distal tip.There were no further details provided regarding the event.No patient involvement on this event.No user injury reported.

• 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
• Manufacturer Contact: kenneth pittman ; 93 north pleasant st.; norwalk, OH 44857 ; 9013785969
• MDR Report Key: 10924697
• MDR Text Key: 222023690
• Report Number: 1519132-2020-00101
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K890328
• 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: 11/30/2020

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: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/03/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/03/2020
• Initial Date FDA Received: 12/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/12/2019
• 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