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

Model Number	E1465-6
Medical Device Problem Codes	Peeled/Delaminated (1454); Flare or Flash (2942)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	10/10/2017
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 during a tonsillectomy, the patient developed a temporary first to second degree burn on the lips.Conservative treatment included cream applied to the burn.Examination of the device found a hole in the insulation.Another device of the same type was used without issue.
Additional Manufacturer Narrative
Correction: additional information: evaluation summary one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the blue heat insulation had a charred hole though it.There were also scratches around the charred area indicating the device may have come into contact with a sharp object.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 instructions for use (ifu) 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: 7004490
• Report Number: 1717344-2017-06159
• Device Sequence Number: 1769879
• Product Code: GEI
• UDI-Device Identifier: 10884521713246
• UDI-Public: 10884521713246
• Combination Product (Y/N): N
• Initial Reporter Country: FI
• PMA/510(K) Number: K955836
• 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): 02/07/2018

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: 02/04/2021
• Device Model Number: E1465-6
• Device Catalogue Number: E1465-6
• Device Lot Number: 60360032X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/13/2017
• Initial Date Received by Manufacturer: 10/11/2017
• Supplement Date Received by Manufacturer: 01/28/2018
• Initial Report FDA Received Date: 11/06/2017
• Supplement Report FDA Received Date: 02/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1