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

Model Number	E1455-6
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	12/09/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during replacement of breast implants, the device was cause a minor burn to the patient.They padded the wound with cold saline.Dressing at end of procedure with bacitracin ointment and xeroform gauze.
Additional Manufacturer Narrative
Additional information: b5, d10, g4, h3, h6 h3.Evaluation summary: one device was received for evaluation.The returned product did not meet specification as received.Visual inspection showed that the blue sleeve had a hole and several scratch marks, indicating mechanical damage.The reported condition of insulation damage was confirmed, but device-related burn to the patient could not be confirmed.Inspection found the blue heat shrink was scratched, and the device failed hipot testing at the damage site.The damage to the electrode indicates the user mishandled the electrodes.It also may have been cleaned with an abrasive material.This cleaning method would also contribute to the insulator disengaging.The investigation identified the root cause of the reported event to be attributed to user handling damage.The instruction for use (ifu) 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, discard it.The reported lot number is not a valid lot number for this product, therefore no examination of the manufacturing records could be perfor med.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
According to the reporter, during replacement of breast implants, the device was cause a minor burn to the patient.They padded the wound with cold saline.Dressing at end of procedure with bacitracin ointment and xeroform gauze.They change the device to a like device to complete the procedure.

• 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: 9529780
• Report Number: 1717344-2019-01700
• Device Sequence Number: 2313583
• Product Code: GEI
• UDI-Device Identifier: 10884521713192
• UDI-Public: 10884521713192
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2020

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: 07/31/2024
• Device Model Number: E1455-6
• Device Catalogue Number: E1455-6
• Device Lot Number: 192380059R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2020
• Initial Date Received by Manufacturer: 12/12/2019
• Supplement Date Received by Manufacturer: 01/13/2020
• Initial Report FDA Received Date: 12/30/2019
• Supplement Report FDA Received Date: 01/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 59 YR
• Patient Weight: 61