MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 30 DEG, 10 X 330MM

Model Number	4K LAPAROSCOPE, 30 DEG, 10 X 330MM
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
This 3500a record is submitted to comply with an fda 483 inspectional observation issued to arthrex inc on may 5, 2023.Arthrex has reassessed the reportability decisions made on historical complaint records using revised criterion.This 3500a document is a result of the reassessment.Event description: it was reported that the optics is sharp-edged.The reported event was confirmed as the visual evaluation revealed the distal end is sharp-edged due to the fact that the keel is protruding out of the distal ends.Complainant¿s event is typically caused if the changing temperatures built up stress on the entire endoscopes during usage time the heating and cooling during reprocessing leads to extension and contraction of the different materials.This stress can be the reason for the keel to protrude out of the distal end.Further the shaft is slightly bend, the distal end has scratches and the attachment for the light guide cable has signs of burns caused by excessive heat.The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.
Event or Problem Description
It was reported that the optics is sharp-edged.There was no harm for the patient, operator or third party reported.No further information received.

• Brand Name: 4K LAPAROSCOPE, 30 DEG, 10 X 330MM
• Common Device Name: LAPAROSCOPE
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: jared engle ; 8009337001
• MDR Report Key: 19483762
• Report Number: 1220246-2024-05190
• Device Sequence Number: 20814322
• Product Code: GCJ
• UDI-Device Identifier: 00888867029729
• UDI-Public: 00888867029729
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K941541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/07/2024

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: 4K LAPAROSCOPE, 30 DEG, 10 X 330MM
• Device Catalogue Number: AR-3351-1030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/18/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2022
• Initial Report FDA Received Date: 06/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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