MAUDE Adverse Event Report: ARTHROCARE CORP. AMBIENT HIPVAC 50 IFS; PUMP, INFUSION, ENTERAL

Catalog Number	ASHA4730-01
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter: (b)(6).
Event or Problem Description
It was reported that the protective ring of head was detached from shaft during ablation.It was removed.The procedure was successfully completed using a back-up device.No patient injury or other complications were reported.
Event or Problem Description
It was reported that the protective ring of head was detached from shaft during ablation.It was removed.The procedure was successfully completed with no significant delay using a back-up device.No patient injury or other complications were 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 wear at distal end.The spacer with the screen/electrodes is completely detached.The part was not returned for investigation.The insulation around the shaft is scratched.There are no manufacturing abnormalities visually observed with the returned device.The wand had no functionality and registered an error e-7 when plugged into a known good quantum2 controller; the suction line was tested and was clogged by dried parts of tissue.A back flush could not clean the line and the suction is still clogged.After bypassing the error e-7 the remaining part of the distal end of the device responded very low when ablate / coag was activated.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 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: PUMP, INFUSION, ENTERAL
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8341378
• Report Number: 3006524618-2019-00095
• Device Sequence Number: 16715423
• Product Code: LZH
• UDI-Device Identifier: 00817470000436
• UDI-Public: 00817470000436
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K040196
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/25/2019

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: ASHA4730-01
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/20/2019
• Initial Date Received by Manufacturer: 01/30/2019
• Supplement Date Received by Manufacturer: 03/22/2019
• Initial Report FDA Received Date: 02/14/2019
• Supplement Report FDA Received Date: 03/25/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 21 YR