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

Catalog Number	ASH4830-01
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2018
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that during knee scope, the face/electrode of the wand came off in the joint.All pieces were removed.There was not delay in the case and back up device was available.Not patient injury was reported.
Additional Manufacturer Narrative
Adverse event or product problem, outcomes attributed to adverse event: information added.Type of reportable event corrected.
Additional Manufacturer Narrative
The device, used in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.Visual inspection under magnification shows the electrodes have been detached with jagged edges on the remaining electrode legs.There is also discoloration on the adhesive and scuff marks on the spacer.There is a significant amount of scratch marks on the exposed shaft and black shrink tube near the tip of the wand.The cable has been severed prior to being received for evaluation; therefore, a functional test could not be conducted.There are no manufacturing abnormalities visually observed with the returned device.The complaint has been visually verified and the root cause was more than likely associated with the device potentially coming into contact with a metal object such as a cannula.Other factors that could have led to tip detachment includes: mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The device, used in treatment, was not returned for evaluation.A relationship, if any, between the subject device and the reported event could not be determined since the product was not returned for evaluation.Visual inspection and functional testing could not be performed because the device in question was not returned for evaluation.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.
Event or Problem Description
It was reported that during knee arthroscopy/meniscectomy, the face/electrode of the wand came off in the joint.X-rays were performed confirming that all parts were found and retrieved.A final lavage was performed looking at all compartments and the gutters.There was a significant delay in the case and back up device was available.Not patient injury was reported.

• Brand Name: SUPER MULTIVAC 50 IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8151375
• Report Number: 3006524618-2018-00638
• Device Sequence Number: 2010004
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: 00817470004908
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 03/28/2019

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
• Operator of Device: Health Professional
• Device Expiration Date: 11/17/2020
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2008296
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/05/2019
• Initial Date Received by Manufacturer: 12/04/2018
• Supplement Date Received by Manufacturer: 01/22/2019; 01/22/2019; 01/23/2019; 03/28/2019
• Initial Report FDA Received Date: 12/11/2018
• Supplement Report FDA Received Date: 01/23/2019; 01/23/2019; 02/06/2019; 03/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 46 YR
• Patient Weight: 89