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 10/21/2020

Event Type  Injury  

Event Description

It was reported that during arthroscopic ligament reconstruction surgery, the electrode of the wand fell inside the patient.The pieces were removed with suction.A backup device was available to complete the procedure with no significant delay or other complications.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.No delay or patient injuries are being reported.Since no harm is being alleged, no further clinical assessment is warranted.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.A complaint history review concluded this was a repeat issue.A review of the instructions for use found statements related to electrode detachment.A review of risk management files found that the reported failure was documented appropriately.Visual inspection of the device showed a detachment of the electrode screen.The device was connected to a known good controller and the wand was tested at default and maximum settings, which revealed that the device performed as intended.The suction line performed as intended.Factors, which may have contributed to the reported complaint include: 1) using the wand above default output settings.2) pressing the tip against hard or bony surfaces.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: 10833002
• MDR Text Key: 216091572
• Report Number: 3006524618-2020-00987
• 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: 12/14/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/09/2022
• Device Model Number: ASC4830-01
• Device Catalogue Number: ASC4830-01
• Device Lot Number: 2031537
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/02/2020
• Initial Date Manufacturer Received: 10/21/2020
• Initial Date FDA Received: 11/12/2020
• Supplement Dates Manufacturer Received: 12/11/2020
• Supplement Dates FDA Received: 12/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 80