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

Catalog Number	ASH4830-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	07/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during an arthroscopy of the right hip, the metal part of the tip of the wand came off as the wand was in the patient.The surgeon researched the piece but the piece has not been found back.No further action has been undertaken for the moment.A backup device was available to complete the procedure with no significant delay or patient injuries.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned for evaluation.There was a relationship found between the device and the reported incident.During functional evaluation the suction line was tested with a syringe and performed as intended.The rest of the functional investigation could not be performed due to the cut junction cable.The complaint was verified and the root cause was undetermined after investigation.Factors unrelated to the design and manufacture of the device which could have contributed to the complaint event includes: (1) the devices may have come into contact with a hard surface such as bone or another piece of equipment which could have caused damaged to the tip, (2) using a set point higher than default settings may increase the wear of the screen / electrodes factored with technique such as amount of pressure and speed in which the wands are passed over tissue.The instruction for use contains precautionary statements associated with the use of the device.There were no indications that would suggest that the device did not meet product specification upon release into distribution.

• 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: 8866493
• Report Number: 3006524618-2019-00371
• Device Sequence Number: 14206274
• Product Code: GEI
• UDI-Device Identifier: 00817470004908
• UDI-Public: 00817470004908
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K083306
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/10/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: ASH4830-01
• Device Lot Number: 2024512
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/15/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 09/09/2019
• Initial Report FDA Received Date: 08/06/2019
• Supplement Report FDA Received Date: 09/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR
• Patient Weight: 55