MAUDE Adverse Event Report: ARTHROCARE CORP. TURBOVAC 90 XL ICW; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Catalog Number	ASC1336-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/22/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
International zip code: (b)(6).
Event or Problem Description
It was reported that the face plate electrode came off from the shaft during a hip arthroscopy.It is believed it was caught on the edge of the slotted cannula when exciting the joint dislodging it from the wands shaft.The electrode was unable to be recovered from the patient and there was a surgical delay greater than 30 minutes.A backup device was available to complete the procedure with no patient injuries.
Additional Manufacturer Narrative
The product, intended for use in treatment, was not returned for evaluation.Per reporter, device was disposed of at the healthcare facility.As such, visual inspection and functional testing could not be performed a relationship, if any, between the subject device and the reported event could not be determined.Thus, the complaint could not be verified, nor could a root cause be determined with confidence.If additional information is received at a future date, this evaluation will be reopened.Potential factors unrelated to the manufacturing or design of the device which could have contributed to the reported event includes: rate of ablation , power settings, and/or prolonged use against dense or bony surfaces.There are no indications to suggest the device did not meet product specifications upon release into distribution.Per our clinical assessment: based on the information provided, the root cause of the broken tip cannot be definitively concluded; however, the ifu does address detachment in the precautions.The instrument is only intended as an externally communicating device; therefore, future patient impact such as local site irritation/corrosion and/or micro-motion of a possibly retained fb could not be ruled out.No patient impact/harm was reported due to the 30-60 minute surgical extension; however, the current patient¿s status remains unknown.No further medical assessment can be rendered at this time.

• Brand Name: TURBOVAC 90 XL ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8960799
• Report Number: 3006524618-2019-00447
• Device Sequence Number: 14071290
• Product Code: GEI
• UDI-Device Identifier: 00817470006520
• UDI-Public: 00817470006520
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K033584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2019

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 Expiration Date: 04/04/2021
• Device Catalogue Number: ASC1336-01
• Device Lot Number: 2012471
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/22/2019
• Supplement Date Received by Manufacturer: 10/31/2019
• Initial Report FDA Received Date: 09/04/2019
• Supplement Report FDA Received Date: 11/01/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 55 YR