MAUDE Adverse Event Report: ARTHROCARE ARTHROCARE MULTIVAC 50XL

Model Number ARTHROCARE MULTIVAC 50XL

Device Problem Device Or Device Fragments Location Unknown (2590)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 09/09/2014

Event Type  malfunction  

Event Description

Product: arthrocare multivac 50xl mfg.By: arthrocare, lot no: 1073296, product catalog #: asc4730-01.Distributed by: arthrocare the small black portion of the tip of the wand came off inside the pt.It was able to be visualize under xray, but could not be retrieved after numberous attempts.It is a retained foreign body.Diagnosis or reason for use: arthroscopy surgery.

• Brand Name: ARTHROCARE MULTIVAC 50XL
• Type of Device: ARTHROCARE MULTIVAC 50XL
• Manufacturer (Section D): ARTHROCARE
• MDR Report Key: 4128496
• MDR Text Key: 4926058
• Report Number: MW5038363
• Device Sequence Number: 1
• Product Code: GEI
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 09/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ARTHROCARE MULTIVAC 50XL
• Device Catalogue Number: ASC4730-01
• Device Lot Number: 1073296
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 18 YR
• Patient Weight: 73