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

Model Number	E1465
Medical Device Problem Code	Detachment Of Device Component (1104)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	07/28/2017
Type of Reportable Event	Serious Injury
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.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 that during a breast augmentation procedure, a 5x2.5mm patient burn occurred on the outer edge of the left nipple, on the lateral most portion of an incision made with the device.Inspection of the device during the procedure found two small areas outside of the needle were missing insulation.A new needle tip was used to continue the procedure.The surgeon debrided and repaired the burned area.No insulation was retrieved, and the issue was noticed mid-procedure.
Additional Manufacturer Narrative
If information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Evaluation summary: one used e1465 electrode was returned, and examination of the sample confirmed factors that may have contributed to the reported issue.Visual inspection found the blue insulating shrink sleeve was damaged in two places, causing the device to fail hipot testing for electrical leakage.No pieces were noted to be missing.The type of damaged observed is indicative that it had been cut by a sharp object.The investigation found the root cause of the issue to be misuse.The instructions included with this device cautions users that 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.It also cautions not to use the electrode if damaged.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: 6832168
• Report Number: 1717344-2017-05813
• Device Sequence Number: 10773431
• Product Code: GEI
• UDI-Device Identifier: 20884521037264
• UDI-Public: 20884521037264
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 02/08/2022
• Device Model Number: E1465
• Device Catalogue Number: E1465
• Device Lot Number: 70300264X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/06/2017
• Initial Date Received by Manufacturer: 08/07/2017
• Supplement Date Received by Manufacturer: 08/07/2017; 09/28/2017
• Initial Report FDA Received Date: 08/30/2017
• Supplement Report FDA Received Date: 08/30/2017; 10/23/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention