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

Catalog Number FORCETRIAD

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report : (b)(6) 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.

Event Description

The customer reported that prior to a procured and during testing an unknown type of monopolar pencil could be activated without a rem plate while used with a forcetriad generator.

Manufacturer Narrative

(b)(4).Date of follow-up report: 10/25/2016.The reported condition was confirmed.The investigation found the generator powered up with the rem icon illuminating green indicating that the generator is capable of delivering energy output.The investigation isolated the failure to the rem calibration, but a root cause was not identified.The probable root cause could not be determined based on the information provided.A complete calibration was performed on the generator to address the condition.No trend has been identified.No corrective action is required, because no trend has been identified.A review of the appropriate device history records indicates that this unit was upgraded and was released meeting all specifications.The appropriate upgrades were implemented.The returned product was calibrated and testing found the generator functions normally.

• 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: 5945504
• MDR Text Key: 54525117
• Report Number: 1717344-2016-00843
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110268
• 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: 08/17/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2016
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/24/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2009
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: UNKNOWN MONOPOLAR PENCIL