MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 0, 5.5MM X 300MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number 4K LAPAROSCOPE, 0°, 5.5MM X 300MM

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Burn, Thermal (2530)

Event Date 10/08/2019

Event Type  malfunction  

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.

Event Description

It was reported that during a diagnostic laparoscopy procedure, the patient got burned.The burn was discovered by the patient after the surgery.The following devices were used during the procedure: ss9-gyw50w108 / batch wo155094, ar-3210-0030, s/n (b)(4), ar-3210-0006, s/n (b)(4), ar-3351-5500, s/n (b)(4).No further information has been made available.

Manufacturer Narrative

No problem found.The evaluation did not identify any issues relevant to the reported event for ar-3351-5500/1279082.

• Brand Name: 4K LAPAROSCOPE, 0, 5.5MM X 300MM
• Type of Device: LAPAROSCOPE, GENERAL & PLASTIC SURGERY
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• MDR Report Key: 10422432
• MDR Text Key: 203454485
• Report Number: 1220246-2020-02062
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867029774
• UDI-Public: 00888867029774
• Combination Product (y/n): N
• PMA/PMN Number: K941541
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 08/10/2021

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?: No
• Device Operator: Health Professional
• Device Model Number: 4K LAPAROSCOPE, 0°, 5.5MM X 300MM
• Device Catalogue Number: AR-3351-5500
• Device Lot Number: 10205539
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 07/27/2020
• Initial Date FDA Received: 08/18/2020
• Supplement Dates Manufacturer Received: 07/27/2020
• Supplement Dates FDA Received: 08/10/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other