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

Device Problems Break (1069); Device Dislodged or Dislocated (2923)

Patient Problem No Information (3190)

Event Date 04/01/2009

Event Type  Injury  

Manufacturer Narrative

This event was identified during literature review of a case occurring in 2009.The part and lot number of the device were not provided and the product will not be returned for evaluation.There are no indications that would suggest that the device did not meet product specifications upon release into distribution.

Event Description

It was reported that the tip of the super multivac wand broke off in the surgical site and was retrieved during an arthroscopy procedure.The patient experienced a post-operative hip dislocation that required surgical intervention for successful repair.

• Brand Name: SUPER MULTIVAC WAND
• 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; austin, TX 78735 ; 5123585706
• MDR Report Key: 5685253
• MDR Text Key: 46096365
• Report Number: 3006524618-2016-00129
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 05/27/2016
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Outcome(s): Required Intervention