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

Catalog Number 72290004

Device Problem Display or Visual Feedback Problem (1184)

Patient Problem No Patient Involvement (2645)

Event Date 05/12/2020

Event Type  malfunction  

Event Description

It was reported that there was a presumption that three (3) "ambient hipvac 50° ifs wands" were part of faulty lots.As a result, the first two wands were tested on the same control unit that has been previously involved in an already reported hip surgery, and showed an ¿e6 error¿.In consequence, the third wand was tested on a different control unit and it worked.The incident occurred during inspection of these three (3) wands.Therefore, there was no patient involvement.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 no relationship found between the returned device and the reported incident.A review of the device history records 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 found no related failures.Visual inspection of the device showed minimal erosion of the screen/electrodes and some discoloration of the spacer.The device's resistance was measure to be 1.7kohms.The device was connected to a known good controller which displayed an "e7 error".The device was then connected to the known good controller using a bypass box, which revealed the device performed as intended.The suction line performed as intended.The complaint was not verified as the device exhibited an error code.The root cause could not be determined.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: (1) previous use (2) disconnecting the wand from the controller after power has been turned on.(3) an issue with one of the concomitant devices in use at the time of this complaint event.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: AMBIENT HIPVAC 50 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10151453
• MDR Text Key: 195272935
• Report Number: 3006524618-2020-00374
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00885556614686
• UDI-Public: 885556614686
• Combination Product (y/n): N
• PMA/PMN Number: K161481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/20/2023
• Device Catalogue Number: 72290004
• Device Lot Number: 2049154
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2020
• Distributor Facility Aware Date: 05/26/2020
• Date Manufacturer Received: 07/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1