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	08/29/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the device is sharp-edged at the distal end.The problem was noticed by reprocessing.There was no harm for patient, operator or third party reported.
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 device is sharp-edged at the distal end.The reported event was confirmed as the evaluation revealed that the wedge on the distal end protrudes slightly.This is typically caused by a large number of heating and cooling cycles, the wedge can move slightly at the distal end and thus protrude, causing the mentioned "sharp-edgedness".The most likely cause for the reported failure can be attributed to misuse/mishandling due to the damage to the device.

• 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: 19574888
• Report Number: 1220246-2024-06272
• Device Sequence Number: 20949985
• 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: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 06/20/2024

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: 11756763
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/12/2022
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/29/2022
• Initial Report FDA Received Date: 06/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2020
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: A
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown