MAUDE Adverse Event Report: ARTHREX, INC. CCU, ARTHREX SYNERGYUHD4, MATRIX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number CCU, ARTHREX SYNERGYUHD4, MATRIX

Device Problems Thermal Decomposition of Device (1071); Electrical /Electronic Property Problem (1198); Melted (1385)

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

Event Date 01/09/2023

Event Type  malfunction  

Event Description

On (b)(6) 2023, it was reported by a sales representative via sems that an ar-3200-0020 ccu had a fault on storx connector where it burnt/melted cord and metal.No case involvement.Additional information has been requested.On 1/10/2023, the sales representative provided the following additional information via phone: the plug into the ccu was burnt on the inside, and also the cable was burnt and the metal was melted where it connected.The staff did not notice any burnt smell or smoke and no one was harmed.This occurred during an unspecified time.

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.

Manufacturer Narrative

The complaint is not confirmed.Visual evaluation: the plate capacitor spring was damaged prior to device return.No other issues were observed.No external evidence of burning was observed.Functional evaluation: ccu (b)(6) was subjected to functional testing per (b)(4).No functional issues were observed.The device was rebooted several times and re-evaluated and no functional issues were observed.All video output ports were individually tested and no functional issues were observed.The light engine led temperature was also measured after 1 hour of the led being illuminated and remained under 48° c.The test light guide was inspected and no damage was detected.The other associated material, "the plug into the ccu," was not returned with the ccu and therefore could not be inspected.The reported event of "an ar-3200-0020 ccu had a fault on storx connector where it burnt/melted cord and metal" was not confirmed.

• Brand Name: CCU, ARTHREX SYNERGYUHD4, MATRIX
• 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: 16263365
• MDR Text Key: 308585476
• Report Number: 1220246-2023-06174
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867216549
• UDI-Public: 00888867216549
• 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,Followup
• Report Date: 05/03/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CCU, ARTHREX SYNERGYUHD4, MATRIX
• Device Catalogue Number: AR-3200-0020
• Device Lot Number: 14913360
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 01/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/25/2022
• Is the Device Single Use?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1