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

Model Number	FORCETRIADZE
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during a procedure, the device did not give a proper seal.There was no patient injury.
Additional Manufacturer Narrative
Evaluation summary: one force triad generator was returned for evaluation.This device has been used in the treatment or diagnosis of a patient.The returned sample did not meet specification as received by medtronic.Exterior inspection found multiple scratch marks and stickers on unit.The reported condition was not confirmed.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.A failure was found during the investigation that did not cause or contribute to the reported condition of inadequate seal.The low voltage power supply cable was found to be discolored.The investigation found the root cause to be a connectivity issue with the low voltage power supply cable.The low voltage power supply cable was replaced to address the condition.Corrective action has been initiated.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORCE TRIAD
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder,co IN 80301 3299
• MDR Report Key: 7378704
• Report Number: 3008361498-2018-00155
• Device Sequence Number: 13959046
• Product Code: GEI
• UDI-Device Identifier: 10884521133310
• UDI-Public: 10884521133310
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K110268
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2018

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
• Operator of Device: Health Professional
• Device Model Number: FORCETRIADZE
• Device Catalogue Number: FORCETRIADZE
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/27/2018
• Initial Date Received by Manufacturer: 03/13/2018
• Supplement Date Received by Manufacturer: 04/13/2018
• Initial Report FDA Received Date: 03/28/2018
• Supplement Report FDA Received Date: 05/09/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1