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	01/21/2022
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
On (b)(6) 2022, it was reported by a sales representative via phone that during an laparoscopic procedure on (b)(6) 2022, the distal tip of the ar-3352-5530 laparoscope became hot and burned a hole in the drape.The surgeon used a blue cloth to cover the burned drape.The patient was not harmed and the case was completed by turning off the scope and after a few minutes they were able to complete the case using the same scope.The sales representative was not present during this case and upon arrival the (b)(6) 2022, was able to collect the device(s) used in the case or evaluation.Additional information provided 1/24/2022: all part and serial numbers were provided.
Additional Manufacturer Narrative
Not confirmed.The evaluation shows that the device performed as intended.

• 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
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 13471643
• Report Number: 1220246-2022-04412
• Device Sequence Number: 1713614
• Product Code: GCJ
• UDI-Device Identifier: 00888867216761
• UDI-Public: 00888867216761
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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): 06/29/2022

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
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/21/2022
• Supplement Date Received by Manufacturer: 01/21/2022
• Initial Report FDA Received Date: 02/07/2022
• Supplement Report FDA Received Date: 06/29/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown