MAUDE Adverse Event Report: ARTHROCARE CORP. SUPER MULTIVAC 50 ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number ASC4830-01

Device Problem Break (1069)

Patient Problem No Information (3190)

Event Date 09/07/2020

Event Type  Injury  

Event Description

It was reported that during a hip arthroscopy, the electrode of the wand's tip fell into the patient when ablation was performed.All pieces were removed using gripping forceps.The procedure was completed without delay using a back-up device.No patient injury or other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.

Manufacturer Narrative

H10 h3, h6 the device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.Visual inspection of the device showed a complete detachment of the electrodes and some contamination around the tip.The device was connected to a known good controller, which revealed that while the device's tip was detached, the wand was able to electrically activate with no issues.The suction line performed as intended.The image provided by the customer showed the device, but did not reveal any information regarding the functionality.The complaint was verified as the device's screen was detached.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: SUPER MULTIVAC 50 ICW
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10605886
• MDR Text Key: 209148570
• Report Number: 3006524618-2020-00835
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470003550
• UDI-Public: 00817470003550
• Combination Product (y/n): N
• PMA/PMN Number: K033584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 10/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/10/2022
• Device Model Number: ASC4830-01
• Device Catalogue Number: ASC4830-01
• Device Lot Number: 2037954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/28/2020
• Date Manufacturer Received: 10/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 56 YR
• Patient Weight: 60