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

Model Number	E1450-4
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/28/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.
Event or Problem Description
The customer reported the edge coating on one side of the blade peeled off as the scrub tech attempted to remove eschar buildup with a raytec.The blade was then removed and a new e1450-4 blade was used to finish the procedure.There was no patient injury.
Additional Manufacturer Narrative
The returned product met specification as received.Visual inspection found the coating to have partially worn away on one side of the electrode.No components were missing.The electrode was attached to a test pencil and activated at 60w.No flame or abnormal effects was noted.The purpose of the coating is to limit the tissue from sticking to the electrode.The coating erodes as the electrode is activated.The tip of the electrode also discolors when activated and used on tissue.This effect is a normal part of electrosurgery and is not considered a defective product.The investigation found the device to function normally.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer reported the edge coating on one side of the blade peeled off as the scrub tech attempted to remove eschar buildup with a raytec.The blade was then removed and a new e1450-4 blade was used to finish the procedure.There was no patient injury.
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: 6508737
• Report Number: 1717344-2017-05239
• Device Sequence Number: 19165382
• Product Code: GEI
• UDI-Device Identifier: 20884521036946
• UDI-Public: 20884521036946
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/23/2017

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: 02/20/2019
• Device Model Number: E1450-4
• Device Catalogue Number: E1450-4
• Device Lot Number: 40480008X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/05/2017
• Initial Date Received by Manufacturer: 03/28/2017
• Supplement Date Received by Manufacturer: Not provided; 05/23/2017
• Initial Report FDA Received Date: 04/20/2017
• Supplement Report FDA Received Date: 06/07/2017; 10/02/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1