MAUDE Adverse Event Report: ARTHREX, INC. 4K LAPAROSCOPE, 0 DEG, 10 X 330MM; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number	4K LAPAROSCOPE, 0 DEG, 10 X 330MM
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/14/2022
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 (b)(6) that during a procedure an ar-3351-1000 arthroscope was connected and light engine on while sitting on a drape.The arthroscope while sitting on the drape caused a fire.No additional information provided.Additional information requested.Additional information provided 1/18/2022 by a sales representative via phone that no patient was harmed and the case was completed by using the same device.The sales representative was not present during this case and upon arrival on the (b)(6) 2022, was advised by the facility that the device was sterilized and placed back into circulation.The serial number was not captured and will not be returning.
Additional Manufacturer Narrative
The event was confirmed via picture of the burnt drape.The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The probable cause of the event could not be determined from the information available and without device evaluation.As no further investigation was able to be performed no change in harm was identified.This complaint will be included in trending per (b)(4).

• Brand Name: 4K LAPAROSCOPE, 0 DEG, 10 X 330MM
• 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: 13397283
• Report Number: 1220246-2022-04364
• Device Sequence Number: 4710664
• Product Code: GCJ
• UDI-Device Identifier: 00888867029705
• UDI-Public: 00888867029705
• 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): 02/10/2022

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, 0 DEG, 10 X 330MM
• Device Catalogue Number: AR-3351-1000
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/14/2022
• Supplement Date Received by Manufacturer: 01/14/2022
• Initial Report FDA Received Date: 01/31/2022
• Supplement Report FDA Received Date: 02/10/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown