MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 30¿, 10X330MM, NIR

Model Number	4K LAPAROSCOPE, 30¿, 10X330MM, NIR
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/29/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event was confirmed as the evaluation revealed that the eyepiece is damaged, a part is broken off (see evaluation pictures 1 + 2).A most likely cause is hitting the endoscope, dropping the endoscope, or improper use / handling.Further the distal tip is damaged and the shaft has scratches (see evaluation pictures 3 - 5).
Event or Problem Description
It was reported that the eyepiece of the laparoscope is broken off.It was noticed after the surgery.There was no harm for patient, operator or third party.No further information received.

• Brand Name: 4K LAPAROSCOPE, 30¿, 10X330MM, NIR
• 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: emily shafer ; 8009337001
• MDR Report Key: 18011800
• Report Number: 1220246-2023-08389
• Device Sequence Number: 7537722
• Product Code: GCJ
• UDI-Device Identifier: 00888867161122
• UDI-Public: 00888867161122
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K223759
• 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): 10/26/2023

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¿, 10X330MM, NIR
• Device Catalogue Number: AR-3351-1031
• Device Lot Number: 12463738
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/29/2023
• Initial Report FDA Received Date: 10/26/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/19/2020
• 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