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

Model Number	E2100
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/16/2019
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, the pencil were wrinkled and stripped from their outer shell of the wires eventually tearing apart during use and autoclave which was done according to the instructions.
Additional Manufacturer Narrative
Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received because the cable showed slit damage.Visual inspection found the outer sheath of insulation of the cord was damaged.The wires inside the sheath were exposed.The primary wire insulation was not damaged.The reported condition was confirmed.A tear was noted in the outer layer of insulation on the cord.The damage allowed the outer sheath of pull back from the pencil body exposing the wires in the cord.The device was hipot-tested.The damaged area passed hipot testing.The device with plugged into a generator and activated at 60w.No arcing or sparking occurred from the cord.No other defects were found with the device.There is nothing in the manufacturing process that would have contributed to this type of failure.The damage appeared to come from interaction with a sharp tool e.G., a knife.The investigation identified the probable root cause to be from user misuse.The instructions for use (ifu) states, inspect the pencil and cable for: cuts in the rocker cover, exposed wires or cracks in the cord, bent electrode contact.Discard if the pencil cord is damaged.If information is provided in the future, a supplemental report will be issued.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 9072160
• Report Number: 1717344-2019-01174
• Device Sequence Number: 13949299
• Product Code: GEI
• UDI-Device Identifier: 20884524001590
• UDI-Public: 20884524001590
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K942183
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/05/2020

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: E2100
• Device Catalogue Number: E2100
• Device Lot Number: 71130143X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/14/2020
• Initial Date Received by Manufacturer: 08/21/2019
• Supplement Date Received by Manufacturer: 01/23/2020
• Initial Report FDA Received Date: 09/16/2019
• Supplement Report FDA Received Date: 02/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1