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

Model Number M3-30A

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Device was received and evaluated.Evaluation determined that the device was found with chipped meniscus causing debris.Fractured lens were observed causing cloudy image.Minor debris underneath the cover glass on eye cup was observed.The identified parts needs to be replaced.The device was placed for repair.

Event Description

It was reported that during preparation for use, the device was found with cracked distal tip.There was no patient involvement.No user harm, or injury reported.

Manufacturer Narrative

This supplemental report is being submitted to provide review of the device history records (dhr).Please see updated sections: g4, g7, h2, h3,h4, h6 and h10.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 physical damage found to meniscus of the device is a known failure mode, and was most likely due to user mishandling.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 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: 10649140
• MDR Text Key: 210415399
• Report Number: 1519132-2020-00088
• 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: 11/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2020
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2020
• 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