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

Catalog Number ASHA4830-01

Device Problems Difficult to Remove (1528); Device Or Device Fragments Location Unknown (2590); Detachment of Device or Device Component (2907)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 03/31/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(6).

Event Description

It was reported the ambient super multivac 50 wand the distal tip of the wand detached and fell into patient's joint.The surgeon was unable to retrieve the detached tip and it was abandoned inside the surgical site.There have been no patient complications reported as a result of this event.

Manufacturer Narrative

The complaint was visually verified upon evaluation of the device.The root cause was more than likely associated with the device potentially coming into contact with a metal object such as a cannula.It is also possible that mechanical displacement of tissue through applied force or using the device as a lever to enlarge a surgical site or gain access to tissue can also cause this type of failure.The instruction for use (¿ifu¿) outlines warnings and precautionary measures to adhere to during activation of the device.There were no indications during manufacturing record review that would suggest that the device did not meet product specifications upon release into distribution.

• Brand Name: AMBIENT SUPER MULTIVAC 50 IFS
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer (Section G): ARTHROCARE CORP.; 7000 w. william cannon; austin TX 78735
• Manufacturer Contact: jim gonzales ; 7000 w. william cannon dr.; austin, TX 78735 ; 5123585706
• MDR Report Key: 5544698
• MDR Text Key: 42455094
• Report Number: 3006524618-2016-00075
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K083306
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/02/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/04/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASHA4830-01
• Device Lot Number: 1128034
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/17/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/31/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1