MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER FORCE EZ; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number FORCEEZ-8C

Device Problems Device Alarm System (1012); Inaccurate Delivery (2339); Failure to Align (2522)

Patient Problem No Patient Involvement (2645)

Event Date 05/27/2020

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found that the unit had a failure due to calibration.It was reported that the device had an unknown rem issue, and the device activated an alarm.The reported issues were confirmed.The most likely cause was traced to a component failure.The manufacturing records for each device are also thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during setup, the unit's rem signal remained red when it should have turned to green.They used a new generator with the same rem pad and it worked successfully.There was no patient involvement.Medtronic initial investigation found that rem needed calibration.

• Brand Name: FORCE EZ
• Type of Device: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 10431808
• MDR Text Key: 203690182
• Report Number: 1717344-2020-00902
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521512085
• UDI-Public: 10884521512085
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K944602
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: FORCEEZ-8C
• Device Catalogue Number: FORCEEZ-8C
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2020
• Date Manufacturer Received: 07/30/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/03/2016
• 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