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).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 procedure a wolf scope and cord would only activate intermittently during use with 3 forcetriad generators.This issue resulted in the procedure being aborted after the patient had been anesthetized.No tissue effect occurred when the loop was placed inside the patient.The loop was replaced, however when the customer tried to activate it within the patient it would not work.They tried three different forcetriad units, three different wolf cords, and two wolf loops and the issue occurred each time.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: 5936468
• MDR Text Key: 54202216
• Report Number: 1717344-2016-00835
• 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: 37 YR
• Patient Weight: 70