MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENT; BIVAP ELECTRODE

Model Number 46300223

Device Problem Sparking (2595)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/15/2014

Event Type  malfunction  

Event Description

Cysto resecting sheath started to spark at distal end during surgery.The procedure was discontinued and patient was assessed with no harm.Equipment removed from service.

• Type of Device: BIVAP ELECTRODE
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENT; vernon hills 60061
• MDR Report Key: 4198994
• MDR Text Key: 21972674
• Report Number: MW5038760
• Device Sequence Number: 1
• Product Code: FDC
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/31/2016
• Device Model Number: 46300223
• Device Lot Number: 453111
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 86 YR