MAUDE Adverse Event Report: COVIDIEN LP FT SERIES VESSEL SEALING GENERATOR; ELECRTOSURGICAL GENERATOR

Catalog Number VLFT10GEN

Device Problem Failure to Obtain Sample (2533)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 08/09/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).To date the unit has not been received for evaluation.If the sample is received or if additional information pertinent to the incident is obtained a follow-up report will be submitted.A review of the device history records indicated that this serial number was released meeting all specifications as manufactured.

Event Description

The customer reported that during a mastectomy an arc was made between the handpiece being used with a ft10 generator and the port guide wire of a left subclavian bard port catheter resulting in a sponge and drapes adjacent to the field to ignite.The fire was stamped out in seconds and the field was covered with a wet sponge.Patient received a small 2x1 first degree burn to the skin.The area was dressed with polysporin and gauze.The customer has reported this incident under mw5064092.

Manufacturer Narrative

(b)(4).The unit was returned and the investigation did not identify anything that would have caused or contributed to the reported event.The unit was found to function normally and within specification.

• Brand Name: FT SERIES VESSEL SEALING GENERATOR
• Type of Device: ELECRTOSURGICAL GENERATOR
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon murphy ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5936738
• MDR Text Key: 54276177
• Report Number: 1717344-2016-00785
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 08/11/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/08/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/23/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/15/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/30/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1