MAUDE Adverse Event Report: COVIDIEN LP FORCETRIAD ENERGY PLATFORM; ELECTROSURGICAL GENERATOR

Catalog Number FORCETRIAD

Device Problem Failure to Obtain Sample (2533)

Patient Problem Partial thickness (Second Degree) Burn (2694)

Event Date 05/04/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: 06/08/2016.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 a 2nd degree patient burn during a whipple procedure.Burn treated by bandage.Customer would not disclose any further information.

• Brand Name: FORCETRIAD ENERGY PLATFORM
• Type of Device: ELECTROSURGICAL GENERATOR
• Manufacturer (Section D): COVIDIEN LP; 5920 longbow drive; boulder CO 80301
• Manufacturer Contact: sharon ; 5920 longbow drive; boulder, CO 80301 ; 2034925267
• MDR Report Key: 5705818
• MDR Text Key: 46777413
• Report Number: 1717344-2016-00401
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: IN
• PMA/PMN Number: K110268
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 05/10/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: FORCETRIAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/10/2016
• Initial Date FDA Received: 06/08/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2011
• 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
• Treatment: UNKNOWN VALLEYLAB DEVICE.