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

Model Number	FT3000DB
Medical Device Problem Codes	Peeled/Delaminated (1454); Material Integrity Problem (2978)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	11/01/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Evaluation summary: to date, the incident sample has not been received for evaluation.If the sample is received, or if additional information pertinent to the incident is obtained, a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, the device had an insulation issue that was identified prior to use.The insulation on the handpiece appeared damaged/torn and the cord also seemed melted.There was no patient involvement.
Additional Manufacturer Narrative
Evaluation summary one device was received for evaluation.This device had not been used in the treatment or diagnosis of the patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the cord outer insulation is damaged, exposing the inner primary wires.The reported condition was confirmed.The device was forwarded to engineering for further evaluation.Engineering determined that the device was caught in the seal plate of the sealing machine.Manufacturing was operating the machine at speeds too fast for the operators to carefully load the product into the package and prevent the cord from entering the seal area.This product was misloaded with the wire inside the seal area and was pinched in the tooling.The cored passed hipot testing.Manufacturing performs a 100% visual inspection in addition to a statistical sampling of finished product as verification.The damage device should have been rejected by manufacturing.The investigation identified the root cause of the reported event to be manufacturing operating machine to fast for the product to be carefully loaded into the packages.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: 7060198
• Report Number: 1717344-2017-06280
• Device Sequence Number: 2037290
• Product Code: GEI
• UDI-Device Identifier: 20884524001934
• UDI-Public: 20884524001934
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• 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: Health Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/15/2018

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 Expiration Date: 04/05/2022
• Device Model Number: FT3000DB
• Device Catalogue Number: FT3000DB
• Device Lot Number: 70950220X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/17/2017
• Initial Date Received by Manufacturer: 11/01/2017
• Supplement Date Received by Manufacturer: 01/19/2018
• Initial Report FDA Received Date: 11/27/2017
• Supplement Report FDA Received Date: 02/15/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1