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

Catalog Number VLFT10GEN

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/07/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: 09/01/2016.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 colorectal case while using a ft10 generator, mill precision rp2 foot pedal and a non medtronic laparoscopic hook that the ft10 continued to deliver energy after the pedal was released.No patient injury occurred.

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: ELECTROSURGICAL 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: 5922327
• MDR Text Key: 53734399
• Report Number: 1717344-2016-00823
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2016
• 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: 10/04/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/16/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/31/2015
• 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