MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC EZ CLEAN LAPAROSCOPIC ELECTRODE, L-HOOK, LONG

Model Number	0020L
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Date of Event	03/29/2017
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Inspection of the returned device under magnification revealed damage to the insulation allowing the high frequency current intended for cutting and coagulation to exit through the area of damage.There are multiple markings on the device indicating exposure to conditions beyond the scope of the design and the intended use of the device.The intended use does not involve tissue contact with the insulated portion of the device.Megadyne will recommend a review of other components the device may have come in contact with during the procedure to prevent future damage.We consider this matter to be closed.
Event or Problem Description
During a transaxillary breast augmentation, the insulation on the laparoscopic electrode was compromised.There resulted two burns to the left shoulder area as a result of the compromised insulation and the alternate current site which resulted.The physician classified the burns as 3rd degree and approximately 1cm x 3cm and 2cm x.5cm.The burned tissue was excised and primarily closed.

• Brand Name: EZ CLEAN LAPAROSCOPIC ELECTRODE, L-HOOK, LONG
• Common Device Name: LAPAROSCOPIC ELECTRODE
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC; 11506 south state street; draper UT 84020
• MDR Report Key: 6508522
• Report Number: 1721194-2017-00006
• Device Sequence Number: 1457619
• Product Code: NUJ
• UDI-Device Identifier: 10614559102602
• UDI-Public: (01)10614559102602
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/20/2017

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?: No
• Operator of Device: Physician
• Device Model Number: 0020L
• Device Catalogue Number: 0020L
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2017
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2017
• Initial Report FDA Received Date: 04/20/2017
• 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: Other