MAUDE Adverse Event Report: GYRUS ACMI, INC. REPAIR SCOPE AUTOCLAVABLE

Model Number	REXM3-30A
Medical Device Problem Codes	Thermal Decomposition of Device (1071); Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Based on the results of the investigation, it is likely that the damage observed on the distal end resulted from improper handling of the device.However, the root cause could not be conclusively determined.The device was manufactured in october 2016, but the specific date is unknown.A review of device history record and historical complaints analysis was conducted and no deviations that could have caused or contributed to the reported issue was identified.The event can be prevented by following the instructions for use (ifu): the device ifu (instructions for use_ 99-1080_bg) 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;" "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) should additional relevant information become available, a supplemental report will be submitted.Olympus will continue to monitor the field performance of this device.
Event or Problem Description
It was observed during the device inspection, the distal tip of the repair scope was burned and had a peeling metal piece.There were no reports of patient involvement.

• Brand Name: REPAIR SCOPE AUTOCLAVABLE
• Common Device Name: 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: 20493280
• Report Number: 3011050570-2024-00445
• Device Sequence Number: 19860042
• 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,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 10/21/2024

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: Other
• Device Model Number: REXM3-30A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/02/2024
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/02/2024
• Initial Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2016
• 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