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

Catalog Number FORCETRIAD

Device Problem Failure to Obtain Sample (2533)

Patient Problem No Code Available (3191)

Event Date 08/11/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Date of initial report: 09/08/2016.The customer has indicated the generators used will not be returned to medtronic for evaluation as they were tested by the facility biomed and performed satisfactorily.A review of the device history records for all 3 generators used indicated that the serial numbers were released meeting all specifications as manufactured.

Event Description

The customer reported that during a hysteroscopy with endometrial ablation a wolf scope would only activate intermittently during use with multiple forcetriad generators and a wolf cord.This issue resulted in the procedure being aborted after the patient was anesthetized.Customer verified the cord is seated in the unit correctly and the settings were at 120w in cut and coag.Testing of the instrument in between procedures found no issues.Nova plus patient return pads were in use and one was tried on both thighs.Each time the rem icon turned green.No injury to the patient.Patient is currently in good health.

• 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: 5936428
• MDR Text Key: 54200348
• Report Number: 1717344-2016-00836
• 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: Nurse
• Type of Report: Initial
• 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: FORCETRIAD
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/11/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/30/2015
• 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
• Patient Age: 31 YR
• Patient Weight: 112