MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGY UHD4; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CCU, ARTHREX SYNERGY UHD4

Device Problems Thermal Decomposition of Device (1071); Overheating of Device (1437)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/10/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022 it was reported by a sales representative via (b)(6) that an ar-3200-0021 synergy console was involved in a case when the drape was burnt.Additional information has been requested.Additional information provided (b)(6) "2002": during a shoulder repair the light switch auto was switched to on and the camera was sitting on a mayo stand prior to the case.The drape on the stand heated up and a burn was visible.The camera head involved was an ar-3210-0031.There was no patient injury.The equipment was traded out and replaced then the case was completed successfully with no further issues.There was no arthrex rep present at this case.The information was provided when a rep went to the facility to investigate.

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.

• Brand Name: CCU, ARTHREX SYNERGY UHD4
• 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: 13620590
• MDR Text Key: 289070293
• Report Number: 1220246-2022-04519
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867197022
• UDI-Public: 00888867197022
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/28/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CCU, ARTHREX SYNERGY UHD4
• Device Catalogue Number: AR-3200-0021
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 02/10/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1