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

Catalog Number ASHA4730-01

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/22/2019

Event Type  malfunction  

Manufacturer Narrative

Foreign zip code (b)(6).

Event Description

It was reported that during a hip arthroscopy the electrode head detached during ablation, the pieces were removed with ask forceps.A backup device was available to complete the procedure with no significant delay or patient injuries.

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 returned for investigation.There are no manufacturing abnormalities visually observed with the returned device.The device had no functionality and registered an error e-7 when plugged into a known good quantum2 controller.The suction line was tested and performed as intended.After bypassing the error e-7 the remaining part of the distal end of the device responded 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
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• MDR Report Key: 8319734
• MDR Text Key: 135947150
• Report Number: 3006524618-2019-00082
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 00817470000436
• UDI-Public: 00817470000436
• Combination Product (y/n): N
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/11/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASHA4730-01
• Device Lot Number: 2019198
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/07/2019
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 45 YR