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

Model Number	E1450-6
Medical Device Problem Codes	Peeled/Delaminated (1454); Flare or Flash (2942)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/05/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The incident sample was requested but to date has not been received for evaluation.If the sample or 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
The customer reported that burn marks occurred on the patient skin during a breast augmentation procedure.Examination of the device during the procedure found holes in the blue insulation.The device was in use with a valleylab forcefx generator at the settings of 40w spray.A second edge blade electrode was used with the same generator/accessories and no further issues occurred.
Additional Manufacturer Narrative
Additional information evaluation summary one device was received for evaluation.Visual inspection found the blue heat insulation to have scratches.There was also a charred area.The reported damage to the insulation was confirmed.The investigation found several gash along the blue insulation as if the electrode had grasped and twisted by a metal object or had come into contact with a sharp object.There was also a charred hole in the insulation.The electrode failed hipot testing in this area indicating electrical leakage.Electrodes are 100% inspected prior to shipment.The damage to the blue insulation indicates the device was mishandled.The investigation identified the root cause of the reported event to be attributed to user handling damage.The instruction for use states, before use, examine the electrosurgical unit and accessories for defects.Do not use cables or accessories with damaged (cracked, burned, or taped) insulation or connectors.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: 6985977
• Report Number: 1717344-2017-06122
• Device Sequence Number: 1005117
• Product Code: GEI
• UDI-Device Identifier: 40884524002126
• UDI-Public: 40884524002126
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• 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): 12/21/2017

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: 05/01/2020
• Device Model Number: E1450-6
• Device Catalogue Number: E1450-6
• Device Lot Number: 51240114X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2017
• Initial Date Received by Manufacturer: 10/05/2017
• Supplement Date Received by Manufacturer: 12/02/2017
• Initial Report FDA Received Date: 10/27/2017
• Supplement Report FDA Received Date: 12/21/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 18 YR