MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE,0¿, 10X330MM, NIR

Model Number	4K LAPAROSCOPE,0¿, 10X330MM, NIR
Medical Device Problem Code	Fogging (1253)
Health Effect - Clinical Code	Liver Laceration(s) (1955)
Date of Event	12/12/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during a laparoscopic cholecystectomy excessive fogging was noticed on the scope.The surgeon decided to continue to the surgery with the device.During the surgery however due to obstructed view the surgeon caused a laceration to the liver due to the fogging.The patient was kept overnight to be monitored but no further treatment was reported.
Additional Manufacturer Narrative
The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.Investigation is in process.A follow-up report will be provided upon availability of additional information.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 since the device was not received, an evaluation on the product could not be performed and the reported event cannot be verified.Obstructed views are most likely resulting from damages at the distal end and fiber optics caused by improper device handling.

• Brand Name: 4K LAPAROSCOPE,0¿, 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: jared engle ; 8009337001
• MDR Report Key: 18877363
• Report Number: 1220246-2024-01411
• Device Sequence Number: 12731792
• Product Code: GCJ
• UDI-Device Identifier: 00888867161115
• UDI-Public: 00888867161115
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/10/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 4K LAPAROSCOPE,0¿, 10X330MM, NIR
• Device Catalogue Number: AR-3351-1001
• Device Lot Number: 12235133
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/12/2023
• Supplement Date Received by Manufacturer: 12/13/2024
• Initial Report FDA Received Date: 03/11/2024
• Supplement Report FDA Received Date: 01/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2020
• 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: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Sex: Unknown