MAUDE Adverse Event Report: GYRUS ACMI, INC. REPAIR SCOPE AUTOCLAVABLE; RIGID ENDOSCOPE TELESCOPE

Model Number	REXM3-30A
Medical Device Problem Code	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was returned to olympus for inspection, and the tip of the scope was found to be burnt and deformed; however, the sharpness of the tip was not specifically noted.Based on the investigation, it is likely that the observed damage on the distal end resulted from improper handling of the device.However, the root cause of the complaint could not be conclusively determined.A device history review revealed no issues that could have caused or contributed to the reported issue.This issue is addressed in the instructions for use (ifu), instructions for use_ 99-1080_bg: "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;" "keep the distal tip of any electrode, probe, laser fiber, or other ancillary device in the field of view at all times when active" (page 4).Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was reported that the distal end of the rigid scope had burn damage and was sharp.This issue was found during reprocessing.There was no patient involved and there were no reports of patient harm.

• Brand Name: REPAIR SCOPE AUTOCLAVABLE
• Common Device Name: RIGID ENDOSCOPE TELESCOPE
• 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: 19509716
• Report Number: 3011050570-2024-00223
• Device Sequence Number: 11614191
• Product Code: HIH
• UDI-Device Identifier: 00821925007802
• UDI-Public: 00821925007802
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K890328
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/11/2024

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: REXM3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/15/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/15/2024
• Initial Report FDA Received Date: 06/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown