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

Model Number SALES LEVEL,CCU,SYNERGY HD3,TURRET

Device Problems No Display/Image (1183); Image Display Error/Artifact (1304)

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

Event Date 07/20/2023

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 07/20/2023, it was reported by a sales representative via sems that an ar-3200-0001t ccu is not showing an image.This was discovered during a case with no patient effect.

Manufacturer Narrative

(isolation board) the reported event of "an ar-3200-0001t ccu is not showing an image" was confirmed.This evaluation determined that the reported event occurred due to an isolation board failing as a result of normal wear and tear.

• Brand Name: SALES LEVEL,CCU,SYNERGY HD3,TURRET
• Type of Device: 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: emily shafer ; 8009337001
• MDR Report Key: 17576985
• MDR Text Key: 321953083
• Report Number: 1220246-2023-07568
• 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: 10/25/2023

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
• 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
• Initial Date Manufacturer Received: 07/20/2023
• Initial Date FDA Received: 08/18/2023
• Supplement Dates Manufacturer Received: 07/20/2023
• Supplement Dates FDA Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/20/2020
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1