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	Sharp Edges (4013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
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.The complaint device was not received for evaluation.Based off the information provided, 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 device is sharp-edged and cloudy.There was no harm or adverse event for 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: 19503383
• Report Number: 1220246-2024-05466
• Device Sequence Number: 7925984
• 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,Distributor
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/10/2024

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: 04/11/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/07/2022
• Initial Report FDA Received Date: 06/10/2024
• 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