MAUDE Adverse Event Report: ARTHROCARE CORP SUPER TURBOVAC 90IFS; ARTHROCARE WAND

Model Number ASH 4250-01

Device Problems Break (1069); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/02/2014

Event Type  malfunction  

Event Description

Midway intraoperatively, while the surgeon - dr (b)(6) was using the arthrocare super turbovac 90 on a left shoulder arthroscopy case, he noted a tiny piece of a port of the clear plastic coating on the tip of the disposable instrument - has broken off.Surgeon attempted to locate broken piece to no avail.We are a surgery center, this was disposable arthroscopy wand.The plastic was noticed as broken during the case.Switched out for a new wand.The broken device returned to the company.No harm to the pt, the surgery proceeded as planned.

• Brand Name: SUPER TURBOVAC 90IFS
• Type of Device: ARTHROCARE WAND
• Manufacturer (Section D): ARTHROCARE CORP; austin TX
• MDR Report Key: 4014027
• MDR Text Key: 19090869
• Report Number: 4014027
• Device Sequence Number: 1
• Product Code: GEI
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/02/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/01/2017
• Device Model Number: ASH 4250-01
• Device Lot Number: 1061698
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/02/2014
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/02/2014
• Device Age: 1 YR
• Event Location: Ambulatory Surgical Facility
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 73