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	Foreign Body In Patient (2687)
Date of Event	10/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).
Event or Problem Description
It was reported that during the surgery after a few minutes of use, the electrode of the hipvac 50 broke off and fell off inside the patient's joint.The surgeon removed the electrode using a grasper.No patient injuries or significant delay reported.Back-up device was available to complete the surgery.All available information has been disclosed.If additional information should become available, a supplemental report will be submitted accordingly.
Additional Manufacturer Narrative
The returned device, used in treatment, was returned as an mdr for evaluation.There was a relationship between the returned devices and the reported event.Review of complaint history of the reported lot number 2031558 for the past 3 years found no other similar complaints.A review of manufacturing records for the reported lot number 2031558 found no non-conformances or anomalies during manufacturing process related to the reported event.Visual inspection under magnification of the wand shows a detached tip of the wand.This includes the spacer with the electrodes.The part was separately returned with the device and shows contamination/ discoloration and scuff/scratch marks.There are no manufacturing abnormalities visually observed with the returned wand.The device was plugged into a known good controller and tried to excite plasma on the remaining stubs of the wires at the tip of the device.Despite the damage the suction line was tested and performed as intended.The complaint was verified and the root cause was determined to be associated with the device potentially coming into contact with the boundaries of a metal object such as the slotted cannula.Other possible factors that could contribute to the reported event include using the device as a leverage to enlarge surgical site or mechanical displacement of tissue.There were no indications that would suggest that 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: 9281872
• Report Number: 3006524618-2019-00539
• Device Sequence Number: 14162290
• Product Code: GEI
• UDI-Device Identifier: 00817470000436
• UDI-Public: 00817470000436
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• 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): 02/14/2020

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: 04/05/2022
• Device Model Number: ASHA4730-01
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 2031558
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/30/2019
• Initial Date Received by Manufacturer: 10/11/2019
• Supplement Date Received by Manufacturer: 02/13/2020
• Initial Report FDA Received Date: 11/05/2019
• Supplement Report FDA Received Date: 02/14/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1