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

Model Number M3-30A

Device Problem Material Twisted/Bent (2981)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The reported device was returned to olympus for evaluation, and the customer's complaint was confirmed.The device evaluation determined that the outer tube was dented.In addition, the system lens was found to be broken, causing image loss.The investigation is still ongoing and the exact cause of the reported event could not be determined at this time.However, when additional significant information becomes available, this report will be updated accordingly.

Event Description

Olympus was informed that during preparation for use, the autoclavable foroblique 30 degree telescope's outer tube was found bent.There was no patient involvement, and no user injury reported.

Manufacturer Narrative

This supplemental report was submitted to provide additional information from the original equipment manufacturer for mdr# 1519132-2020-00097 the oem performed a device history record review; no abnormalities were found.An investigation was completed by the oem and determined that there is no manufacturing, material or processing related cause for this failure mode.Based on device the inspection results, it was likely that the damage to the outer tube led to lens fracture, causing image loss.The potential root cause of these damages can be attributed to user mishandling.To minimize device damages, the instructions for use (ifu) provides warnings and cautions to alert that the device may be damaged by improper handling.The ifu 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." (warnings, page 4).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: 10825715
• MDR Text Key: 216701146
• Report Number: 1519132-2020-00097
• Device Sequence Number: 1
• Product Code: FAS
• UDI-Device Identifier: 00821925005679
• UDI-Public: 00821925005679
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 12/11/2020

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: Other
• Device Model Number: M3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/16/2020
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/16/2020
• Initial Date FDA Received: 11/11/2020
• Supplement Dates Manufacturer Received: 11/15/2020
• Supplement Dates FDA Received: 12/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1