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

Model Number	E1450-4
Medical Device Problem Code	Peeled/Delaminated (1454)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	03/21/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Inspection of the incident device found the blue insulation was scratched and had a hole it.The electrode failed hipot testing around the damaged insulation.The investigation identified the root cause of the reported event to be attributed to user handling damage.The electrode may have been cleaned with an abrasive material.The instructions for use states the electrode has a coating to reduce sticking of eschar.Cleaning the electrode with a scratch pad or other abrasive object, scraping with a sharp object or bending beyond 90 degrees may damage the electrode.If the electrode is damaged, it should be discarded.
Event or Problem Description
The customer reported that a patient lesion occurred away from the operative area following an electrical arc from the electrode during a whipple procedure.The insulation was reported to have a hole in the proximal part of the electrode.The injury was described as a 1st degree reddened area.No medical intervention was required.The incident pencil was discarded by the customer.An erbe generator was in use at force 60, effect 4, coag mode.The serial number is unknown.Medtronics initial investigation found the insulation on the shaft of the electrode was damaged exposing metal.The device filed hipot testing.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• MDR Report Key: 6581405
• Report Number: 1717344-2017-05346
• Device Sequence Number: 115961
• Product Code: GEI
• UDI-Device Identifier: 10884521713123
• UDI-Public: 10884521713123
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K781511
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/28/2017

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: 07/08/2021
• Device Model Number: E1450-4
• Device Catalogue Number: E1450-4
• Device Lot Number: 61910002X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/14/2017
• Initial Date Received by Manufacturer: 04/28/2017
• Supplement Date Received by Manufacturer: 04/28/2017
• Initial Report FDA Received Date: 05/22/2017
• Supplement Report FDA Received Date: 09/07/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 71 YR