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

Catalog Number	AC1336-01
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/30/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during surgery when the product was used for the first time, it worked at first but then suddenly did not work.There was no backup device available.No significant delay or patient injury reported.
Additional Manufacturer Narrative
The returned device, used in treatment, was returned for evaluation.There was a relationship between the returned device and the reported event.Visual inspection under magnification of the wand shows moderate electrode wear.The insulation on the shaft is in its original condition.There are no manufacturing abnormalities visually observed with the returned wand.The device was tested with a known good controller and does not generate any output.The complaint was verified and the root cause could not be determined with confidence.Due to moderate electrode wear, most likely the failure is related to the end of useful life for the device.Factors that could cause this type of failure includes: using set points higher than the default settings or using the wand for an extended period of time.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: LOPRO ICW
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8759631
• Report Number: 3006524618-2019-00318
• Device Sequence Number: 1342184
• Product Code: GEI
• UDI-Device Identifier: 00817470004533
• UDI-Public: 00817470004533
• Combination Product (Y/N): N
• Initial Reporter Country: KS
• PMA/510(K) Number: K033584
• 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): 08/10/2019

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: AC1336-01
• Device Lot Number: 2017873
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2019
• Initial Date Received by Manufacturer: 06/10/2019
• Supplement Date Received by Manufacturer: 08/09/2019
• Initial Report FDA Received Date: 07/03/2019
• Supplement Report FDA Received Date: 08/10/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1