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

Catalog Number	ASHA4730-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/25/2019
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that during an ask hip surgery, the electrode head detached from the electrode during ablation inside the patient, using forceps, the piece was removed.A backup was available to complete the procedure successfully, with no significant delay and no patient injuries reported.
Additional Manufacturer Narrative
The returned device, intended for use in treatment, was returned as an mdr for evaluation.There was a relationship between the returned device and the reported event.Visual inspection under magnification shows extensive screen/electrodes wear with scratch/scuff marks and discoloration on the spacer and cap.The insulation on the shaft is damaged and compromised.The spacer with electrodes is completely detached and was returned with the device.There are no manufacturing abnormalities visually observed with the returned device.During functional evaluation the detached spacer/electrodes from distal end shows strong contamination/discoloration; the part was returned for further investigation with the device; after bypassing the error e-7 the device shows minimal reaction on the end of the wires on ablate/coag min./max.Settings; cause of the detached spacer/electrodes the device produced no longer plasma as specified."hence" any further functional test is impossible.The complaint was verified, however the root cause could not be determined with certainty since the device was comprehensively used.Excessive wear of the distal end including the insulation on the shaft results from vigorous use against bony surfaces; the wand is supplied sterile, and is for single use only.Do not clean, resterilize, or reuse the wand, as this may damage or compromise the performance resulting in product malfunction, failure, or patient injury.Cleaning, resterilization, or reuse of the wand may also expose the patient to the risk of transmitting infectious diseases or results in irregular wear leading to malfunction.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: 8476693
• Report Number: 3006524618-2019-00162
• Device Sequence Number: 1846976
• 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
• Report Date (Section B): 05/22/2019

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: 10/02/2021
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 2021127
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2019
• Initial Date Received by Manufacturer: 03/25/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/03/2019
• Supplement Report FDA Received Date: 05/22/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1