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

Catalog Number FORCETRIAD

Device Problem Failure to Obtain Sample (2533)

Patient Problem Burn(s) (1757)

Event Date 05/19/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: 07/07/2016.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 an alternate site burn during a shoulder procedure while using a forcetriad generator.The customer stated they had completely padded the mayo stand and used it to set the shoulder on during the procedure with the arm draped.Following the procedure they removed the drapes and the patient had a red area proximal from the elbow.

• Brand Name: FORCETRIAD ENERGY PLATFORM
• 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: 5776951
• MDR Text Key: 49023204
• Report Number: 1717344-2016-00598
• Device Sequence Number: 1
• Product Code: GEI
• 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: Other
• Type of Report: Initial
• Report Date: 06/09/2016

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?: No
• Initial Date Manufacturer Received: 06/09/2016
• Initial Date FDA Received: 07/07/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/31/2013
• 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