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	Insufficient Information (4580)
Date of Event	08/01/2022
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 most likely cause for the reported failure can be attributed to misuse/mishandling due to damage to the device.
Event or Problem Description
It was reported that the tip of the optics is very sharp.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: 19472637
• Report Number: 1220246-2024-04998
• Device Sequence Number: 12606564
• 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,Company Representative
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 06/05/2024

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
• Device Lot Number: 11895951
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/01/2022
• Initial Report FDA Received Date: 06/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/02/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown