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

Model Number	FT3000
Medical Device Problem Codes	Inappropriate/Inadequate Shock/Stimulation (1574); Connection Problem (2900)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/12/2018
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, prior the procedure, the device was connected to a generator but the generator display was non responsive indicating the device was not recognized.The device was disconnected from the generator and connected repeatedly for a few times, but the issue was not solved.While disconnecting and connecting the device to the generator, the clinical engineer's hand was in contact with the connection terminal of the handpiece and the hand got burnt because of an electric shock.
Additional Manufacturer Narrative
Evaluation summary: two devices were received for evaluation.This devices had been used in the treatment or diagnosis of a patient.Without the original packaging or a reported lot number, the investigator cannot determine if the product was within the assigned expiration date at the time of reported incident.The returned products met specification as received.Visual inspection found no defects.The reported condition was not confirmed.The investigation found the devices to function normally and within specifications.The devices were recognized when plugged into a generator.The devices were activated five times in all three modes and all five slider positions with no anomalies noted.Manufacturing non-conformance review is not required since the lot number is unknown.If information is provided in the future, a supplemental report will be issued.

• Brand Name: FORCE TRIVERSE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 7645422
• Report Number: 1717344-2018-00868
• Device Sequence Number: 125831
• Product Code: GEI
• UDI-Device Identifier: 10884524000084
• UDI-Public: 10884524000084
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K051627
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,u
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2018

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: FT3000
• Device Catalogue Number: FT3000
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2018
• Initial Date Received by Manufacturer: 06/13/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 08/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: FORCETRIAD