MAUDE Adverse Event Report: ARTHREX, INC. HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE; LAPAROSCOPE, GENERAL & PLASTIC SURGERY

Model Number HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE

Device Problems Material Discolored (1170); Failure to Power Up (1476); Smoking (1585)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/06/2019

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was requested/is expected but has not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported that there was a smoke development at the synergy console, at the connector of the camera head during surgery.The device smelled charred and it was not able to turn on the device.Both affected items will be sent in ar-3200-0021, sn: (b)(4) and ar-3210-0018 sn: (b)(4).They also reported that the amount of smoke was so much that they had to remove the patient in the meantime from the operation room.Update 12-march-2019.They stopped the surgery, removed the patient and then brought back the patient later.

Manufacturer Narrative

Additional information has been added to the event description.Complaint was not confirmed.The device was tested and functional requirements were met.The device was burned in for four hours.After burn-in, three temperature readings were taken and they all met specifications.The device was also tested with ar-3200-0021, sn: (b)(4) (refer to mdr case-2019-18635-1).The evaluation found that the root cause of the issue associated with the reported event was not related to camera head (b)(4).The reported event of 'it was reported that there was a smoke development at the synergy console, at the connector of the camera head during surgery.The device smelled charred and it was not able to turn on the device.

Event Description

It was reported that there was a smoke development at the synergy console, at the connector of the camera head during surgery.The device smelled charred and it was not able to turn on the device.Both affected items will be sent in ar-3200-0021 sn: (b)(4) and ar-3210-0018 sn: (b)(4).They also reported that the amount of smoke was so much that they had to remove the patient in the meantime from the operation room.Update 12-march-2019: they stopped the surgery, removed the patient and then brought back the patient later.Update 04-april-2019: the surgery didn't last any longer, there was no harm for anybody.Nothing remain inside the patient.No new anaesthesia had to be given and the patient did not have to be taken out of the anaesthesia.Update 24-april-2019: the performed surgery was an shoulder arthroscopy.The surgery was completed successfully with a different device.It was not necessary to change the surgical technique or perform a second surgery.No adverse event reported by the customer.

• Brand Name: HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE
• 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: 8457834
• MDR Text Key: 140118868
• Report Number: 1220246-2019-00983
• Device Sequence Number: 1
• Product Code: GCJ
• UDI-Device Identifier: 00888867224056
• UDI-Public: 00888867224056
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K153218
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: HD,SYNERGYUHD4 CAMERA HEAD,AUTOCLAVABLE
• Device Catalogue Number: AR-3210-0018
• Device Lot Number: NB
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2016
• Is the Device Single Use?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other