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

Model Number	M3-12A
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.
Event or Problem Description
As reported, the device was found with sharp edge at distal tip.The issue found during an unknown event.There was no patient involvement associated on this reported event.No user injury was reported.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's investigation.The following sections were updated: b5, d4, d9, e2, e3,g3, g6, h2, h3, h4,h6 and h10.The subject device was received and evaluated.Upon inspection of the returned device, the complaint was confirmed.The outer tube at the distal end was dented and damaged, causing loss of image.The objective cover glass was also broken.Device history records were reviewed and showed the product met all specifications upon release.Based on the device inspection result, damage that occurred to the device was most likely due to user mishandling.The device ifu (instructions for use) advises "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 through regular trending activities and take.
Event or Problem Description
Updates: further communication with the customer did not provide additional information other than confirming that there was no patient involvement when the event occurred and provided her job tile and occupation.No further details provided.

• Brand Name: M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG
• Common Device Name: M3-GOLD AUTOCLAVABLE OPERATIVE TELESCOPE 12 DEG
• Manufacturer (Section D): GYRUS ACMI, INC; 136 turnpike road; southborough MA 01772
• MDR Report Key: 12693737
• Report Number: 1519132-2021-00019
• Device Sequence Number: 1363665
• Product Code: FAS
• UDI-Device Identifier: 00821925005662
• UDI-Public: 00821925005662
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/03/2021

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
• Operator of Device: Health Professional
• Device Model Number: M3-12A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2021
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 10/05/2021
• Supplement Date Received by Manufacturer: 11/03/2021
• Initial Report FDA Received Date: 10/25/2021
• Supplement Report FDA Received Date: 11/03/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1