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

Model Number 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Excessive Heating (4030)

Patient Problems Burn(s) (1757); Superficial (First Degree) Burn (2685)

Event Date 12/22/2022

Event Type  Injury  

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 Description

On 12/22/2022, it was reported by a sales representative via email that a patient was burned after an ar-3210-0033 camera head was placed on the patient after a laparoscopic procedure on (b)(6) 2022.The light cord and scope were disconnected, then the camera was placed on the patients skin, that resulted in a burn.No additional information was provided.Additional information requested.

Manufacturer Narrative

Complaint is confirmed.Upon visual examination, it was noted that one of the lenses is cloudy and the other is discolored around it.However, the camera cannot be on the patient, per dfu-0327-4, section f- safety information-warning: risk of burns! the cause remains misuse.

Event Description

On 12/22/2022, it was reported by a sales representative via email that a patient was burned after an ar-3210-0033 camera head was placed on the patient after a laparoscopic procedure on 12/22/2022.The light cord and scope were disconnected, then the camera was placed on the patients skin, that resulted in a burn.No additional information was provided.Additional information requested.Additional information provided 12/23/22: images of the burn are not available.The camera was by itself when placed on the patient that allegedly caused the burn.The scope and light cord were disconnected.Devices will be returned.Additional information received on 1/13/2023: the patient was burn during the procedure while the scope, light cord, and camera were all attached.Then surgeon turned the rooms light on, at the end of the procedure, the burn was noticed.

• Brand Name: 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
• Type of Device: 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: 16120533
• MDR Text Key: 306887506
• Report Number: 1220246-2023-06051
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867346628
• UDI-Public: 00888867346628
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 05/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/09/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 4K LAPAROSCOPE,30¿,5.5X300MM,HI-MAG, NIR
• Device Catalogue Number: AR-3352-5531
• Device Lot Number: 13970726
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/20/2021
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other