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

Model Number	E0510
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that there was a hole in the cord insulation, exposing the inner wires.There was no patient injury.
Additional Manufacturer Narrative
Correction: additional information: if information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported that they experienced a hole in the cord insulation, exposing the inner wires.The cord had malfunctioned since after a procedure it was noticed that the insulation of the cord had been burned through.Remaining batch of the same cord with same lot number were refused to be used following the event.No patient injury.

• 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: 7047756
• Report Number: 1717344-2017-06259
• Device Sequence Number: 1260011
• Product Code: GEI
• UDI-Device Identifier: 10884524001777
• UDI-Public: 10884524001777
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: PREAMENDMENT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2018

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: 03/26/2022
• Device Model Number: E0510
• Device Catalogue Number: E0510
• Device Lot Number: 1611157X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2017
• Initial Date Received by Manufacturer: 11/02/2017
• Supplement Date Received by Manufacturer: 01/28/2018
• Initial Report FDA Received Date: 11/20/2017
• Supplement Report FDA Received Date: 02/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1