MAUDE Adverse Event Report: GYRUS ACMI, INC. M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG; REPAIR SCOPE AUTOCLAVABLE

Model Number REXM3-70A

Device Problem Sharp Edges (4013)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/03/2023

Event Type  malfunction  

Event Description

The customer reported to olympus that the m3-gold autoclavable lateral telescope 70 deg distal tip had a sharp edge.The event occurred during reprocessing.There was no patient harm associated with the event.

Manufacturer Narrative

The device was returned and evaluated, and the customer¿s allegation was confirmed.Additional findings were as follows: minor dents on outer tube; broken distal edge; debris under eyepiece window; and debris in optical system.The investigation is ongoing, and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the likely cause of the reported event is due to physical stress.However, the root cause of the reported event is unable to be determined.The event can be prevented by following the instructions for use (ifu) which state: " 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;" and "do not use an instrument that fails to meet the criteria stated in the labeling or that has been damaged." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide a correction to model number, unique identifier (udi) number of the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: M3-GOLD AUTOCLAVABLE LATERAL TELESCOPE 70 DEG
• Type of Device: REPAIR SCOPE AUTOCLAVABLE
• Manufacturer (Section D): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer (Section G): GYRUS ACMI, INC.; 9600 louisiana avenue north; brooklyn park MN 55445
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 17994462
• MDR Text Key: 326360540
• Report Number: 3011050570-2023-00162
• 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: Health Professional,User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup,Followup
• Report Date: 12/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/24/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: REXM3-70A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/06/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/21/2022
• 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