MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 30, 5.5X300MM, HI-MAG; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	4K LAPAROSCOPE, 30¿, 5.5X300MM, HI-MAG
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/10/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.If the device becomes available for evaluation, a follow-up report will be submitted.
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy (gallbladder removal), the distal end of the laparoscope outer casing broke off into the patient.The broken part was retrieved from the patient; x-rays were done to confirm all parts removed.The case was completed.
Additional Manufacturer Narrative
Complaint confirmed.Visual evaluation confirmed the condition of the distal tip fibers are broken.The root cause is undetermined, however most likely cause is mechanical shock on the distal end by mishandling.

• Brand Name: 4K LAPAROSCOPE, 30, 5.5X300MM, HI-MAG
• Common Device Name: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 11912159
• Report Number: 1220246-2021-03194
• Device Sequence Number: 3059828
• Product Code: GCJ
• UDI-Device Identifier: 00888867216761
• UDI-Public: 00888867216761
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: K941541
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date (Section B): 08/04/2021

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¿, 5.5X300MM, HI-MAG
• Device Catalogue Number: AR-3352-5530
• Device Lot Number: 10225242
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 05/10/2021
• Supplement Date Received by Manufacturer: 05/10/2021
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 08/04/2021
• Patient Sequence Number: 1