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

Model Number	ASHA4730-01
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	09/07/2020
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during set up of an arthroscopy procedure, the insulation of the ambient hipvac 50 was defective.No delay and a back up was available to complete the procedure.No other complications were reported.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The device intended to be used in treatment, was not returned for evaluation.Thus visual inspection and functional testing could not be performed.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 concluded this was an isolated event.A relationship, if any, between the subject device and the reported event could not be determined.Please refer to the instructions for use for recommendations on proper use of the device and potential troubleshooting methods to prevent future reoccurrence of the reported event.No containment or corrective actions are recommended at this time.If the product associated with this event is returned at a future date, this evaluation will be reopened for investigation.There were no indications that would suggest that the device did not meet product specifications upon release into distribution.
Additional Manufacturer Narrative
The device, intended for use in treatment, was returned for evaluation.There was a relationship found between the returned device and the reported incident.A review of the device history records for the device 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 concluded this was an isolated event.A visual inspection of the returned instrument shows the insulation for the shaft has a tear.A functional evaluation revealed the controller generated an e7 error when the wand was connected.When used with a bypass box the device generated plasma as intended.The resistance measured at 1.04 kilo ohms.The complaint is confirmed.Potential factors unrelated to the manufacture or design of the device that could have contributed to the reported event includes: the wand may have made contact with a hard and/or sharp object(s) that may have caused a tear of the insulation.No containment or corrective actions are recommended at this time.There are no indications to suggest the device did not meet product specifications upon release into distribution.

• Brand Name: AMBIENT HIPVAC 50 IFS
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 10623763
• Report Number: 3006524618-2020-00848
• Device Sequence Number: 19558571
• Product Code: GEI
• UDI-Device Identifier: 00817470000436
• UDI-Public: 00817470000436
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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,Followup
• Report Date (Section B): 04/05/2021

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: 03/15/2021
• Device Model Number: ASHA4730-01
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 2012136
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 09/10/2020
• Supplement Date Received by Manufacturer: 10/26/2020; 03/12/2021
• Initial Report FDA Received Date: 10/02/2020
• Supplement Report FDA Received Date: 11/02/2020; 04/05/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1