MAUDE Adverse Event Report: COVIDIEN LP FT BIPOLAR RESECTION CORD WOLF; WOLF CORD

Catalog Number FT0022W

Device Problems Fire (1245); Melted (1385); Sparking (2595)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/17/2015

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.

Event Description

The customer reported that during a turp procedure the cable, connected to the force triad and the wolf resectoscope, the resectoscope was not working well unless they wiggled the cables.They saw a spark where the cable connects to the instrument at the distal end of the cable.They opened another cable and that one caused a fire at the proximal end closest to the generator.The cable melted immediately where the cable comes out of the black connector that plugs into the unit.They immediately stopped using it and connected a third cable.The procedure was extended by more than 30 minutes.They were able to finish the procedure and the patient is fine.

Manufacturer Narrative

(b)(4).The investigation found during visual inspection the returned cable was missing the female connector.The connector was broken at the point where it attaches to the molded connector.There were no signs of burning or melting of the wire jacket or surrounding area.There were no other obvious signs of damage to the remaining cable.Functional testing showed that the ligasure and male connector met specifications.Due to the inadequate sample, the reported condition of sparking during the procedure could not be confirmed.A review of the appropriate device history record indicates this lot number was released meeting all specification.

• Brand Name: FT BIPOLAR RESECTION CORD WOLF
• Type of Device: WOLF CORD
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5163170
• MDR Text Key: 28958430
• Report Number: 1717344-2015-00728
• Device Sequence Number: 1
• Product Code: JOS
• 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,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/21/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/20/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: FT0022W
• Device Lot Number: T154X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/08/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/09/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/22/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1