MAUDE Adverse Event Report: RICHARD WOLF MEDICAL INSTRUMENTSRICHARD WOLF BIPOLAR CAUTERY CORD

Model Number 8108.033

Event Date 03/15/2011

Event Type  Injury  

Event Description

The bipolar cord was used to connect the megadyne electrocautery to the surgical instrument. The cautery did not work. The electrocautery and cord were removed from service. The next morning, the cord and cautery were connected to "test" the equipment. It was determined that the bipolar cord worked intermittently with manipulation.

• Brand Name: RICHARD WOLF BIPOLAR CAUTERY CORD
• Type of Device: BIPOLAR CAUTERY CORD
• Manufacturer (Section F): RICHARD WOLF MEDICAL INSTRUMENTS; 353 corporate woods pkwy; vernon hill IL 60061
• Manufacturer (Section D): RICHARD WOLF MEDICAL INSTRUMENTS; 353 corporate woods pkwy; vernon hill IL 60061
• Device Event Key: 2064780
• MDR Report Key: 2030582
• Event Key: 1929982
• Report Number: MW5019914
• Device Sequence Number: 1
• Product Code: GEI
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/17/2011

1 Device Was Involved in the Event

1 Patient Was Involved in the Event

• Date FDA Received: 03/24/2011
• Is This An Adverse Event Report?: Yes
• Is This A Product Problem Report?: Yes
• Device Operator: Service Personnel
• Device MODEL Number: 8108.033
• Was Device Available For Evaluation?: Device Returned To Manufacturer
• Date Returned to Manufacturer: 03/16/2011
• Is The Reporter A Health Professional?: Yes
• Was The Report Sent To Manufacturer?: Yes
• Is this a Reprocessed and Reused Single-Use Device?: No
• Is the Device an Implant?: No

Is this an Explanted Device?