MAUDE Adverse Event Report: ARTHREX, INC. SALES LEVEL,CCU,SYNERGY HD3,TURRET; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number SALES LEVEL,CCU,SYNERGY HD3,TURRET

Device Problems Failure to Power Up (1476); Sparking (2595)

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

Event Date 09/08/2022

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.If the device becomes available for evaluation, a follow-up report will be submitted.

Event Description

On (b)(6) 2022, it was reported by a sales representative via sems that an ar-3200-0001t ccu produced sparks from the back and was unable to power on after the incident.No case involvement.

Manufacturer Narrative

The reported event of "unable to power on after the incident" was confirmed and attributed to a failing power supply.The reported event of "an ar-3200-0001t ccu produced sparks from the back" was not confirmed.

• Brand Name: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• 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: 15484387
• MDR Text Key: 301020128
• Report Number: 1220246-2022-05548
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867029163
• UDI-Public: 00888867029163
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K071756
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• Device Catalogue Number: AR-3200-0001T
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/08/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1