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

Catalog Number	FT0021S
Medical Device Problem Code	Arcing (2583)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2016
Type of Reportable Event	Malfunction
Additional 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 or Problem Description
The customer reported that when the product was activated, a spark was activated out of the cable.The product was reviewed and was found damaged, the surgeon continued the surgery in monopolar mode.The patient was not injured.This cable was used 8 times.Initial evaluation of the incident device found a small hole on the side of the connector at resectoscope end and the device failed hipot testing.
Additional Manufacturer Narrative
Covidien reference # : (b)(4).Date of initial report : 7/5/2016.Date of follow-up report : 8/5/2016.The complaint of a spark observed out of the cable (wolf #(b)(4)) when the product was activated, was confirmed.The supplier investigation found a cut or tear in the cable jacket at the proximal end of the small connector adjacent to the strain relief boot.It is not known how the cut occurred but it is located in an area that would likely be flexed and stressed repeated during a typical procedure.The cable inside the cut revealed worn and damaged primary wires and additional damage such as discoloration and bare wires that could have been caused by over use and/or an electrical short.The root cause of the spark could not be confirmed.Dhr review indicated that lot q800 was manufactured to specifications and all required testing was successfully completed prior to shipment of this lot.

• Brand Name: FT BIPOLAR RESECTION CORD STORZ
• Common Device Name: STORZ CORD
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• MDR Report Key: 5705041
• Report Number: 1717344-2016-00488
• Device Sequence Number: 16220812
• Product Code: GEI
• UDI-Device Identifier: 20884521062082
• UDI-Public: 01208845210620821113013010Q800X
• Combination Product (Y/N): N
• Initial Reporter Country: CI
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 05/12/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: FT0021S
• Device Lot Number: Q800X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/12/2016
• Type of Report(Section G): FDA Requested
• Initial Date Received by Manufacturer: 05/12/2016
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/07/2016
• Supplement Report FDA Received Date: 08/05/2016
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1