MAUDE Adverse Event Report: GYRUS ACMI, INC M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG

Model Number M3-12A

Device Problems Poor Quality Image (1408); Defective Device (2588)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received for evaluation.Evaluation determined that the reported issue of blurry image was confirmed however, there were no physical defects of the outer tube and the device was not observed to be bent.Fiber breakage and excessive debris underneath the cover glass on the eyecup were observed causing the blurry image.Based on evaluation findings, the root cause of the reported issue likely attributed to users handling and or maintenance issue of the device.

Event Description

It was reported that the device was found with damaged outer tube, bent and image was blurry.The issue occurred during reprocessing.There was no patient involvement on this report.No user injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr) and investigation conclusion.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.The event found during a reprocessing, fiber breakage causing the debris and blurry image was most likely due to user handling.As stated on the ifu (instruction for use) and as a preventive measure, the user manual 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 complaints for this device.

• Brand Name: M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG
• Type of Device: M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 10672855
• MDR Text Key: 223445838
• Report Number: 1519132-2020-00090
• 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,health
• Type of Report: Initial,Followup
• Report Date: 11/12/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: M3-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/17/2020
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1