MAUDE Adverse Event Report: MEGADYNE MEDICAL PRODUCTS, INC. MEGA 2000

Model Number	0800
Health Effect - Clinical Code	Full thickness (Third Degree) Burn (2696)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).Date sent: 4/21/2020.Date of event: publication year of 2014.Batch # unk.This report is related to a journal article; therefore, no product will be returned for analysis and the manufacturing records cannot be reviewed as the lot/batch number has not been provided.
Event or Problem Description
Title: intraoperative electrical burn caused by stainless tube tree with noncontact electrosurgical ground -a case report.Authors: sung sik park, jung a lim, and jin-seok yeo.Citation: anesth pain med 2014; 9: 274-276.The authors described an accidental intraoperative electrical burn due to improper use of noncontact grounding pad.A (b)(6)-year-old female patient with rectal cancer and rectovaginal fistula presented for an elective abdominoperineal resection, hysterectomy, vagina posterior wall resection.During the procedure, a third degree burn on the third finger of left hand was found.The patient¿s left third finger was contacted to stainless tube tree on the head side of operation table during prone position and scorched stain was found on the tube tree.A noncontact electrosurgical ground (megadyne 2000; ethicon) was set prior to surgery beneath the patient.The ground was slipped in plastic sheath and covered linen sheet without contact of the patient.The burn site was managed with regular sterile dressings and did not require additional surgical procedure.After this event, we changed tube tree to non-conducting material and insulated other metallic objects on the operation table.The patient¿s burn was completely healed in approximately 2 months.The noncontact grounding pad induced current to tube tree and lower resistance of stainless steel made alternate pathway.The impedance of contact area with body and stainless tube tree had high current density and heat built up resulting in a burn.In conclusion, the authors found an accidental intraoperative electrical burn due to improper use of noncontact grounding pad.Largeness of the pad and the flow of electric current without direct contact to metallic object caused electrical burn in this case.Staffs in operating room should be educated not to place metallic object on the pad and remain vigilant for iatrogenic injuries caused by metallic object on the noncontact grounding pad.".

• Brand Name: MEGA 2000
• Common Device Name: MEGA 2000
• Manufacturer (Section D): MEGADYNE MEDICAL PRODUCTS, INC.; 11506 south state street; draper UT 84020
• MDR Report Key: 9983508
• Report Number: 1721194-2020-00032
• Device Sequence Number: 3676184
• Product Code: GEI
• UDI-Device Identifier: 10614559100936
• UDI-Public: 10614559100936
• Combination Product (Y/N): N
• PMA/510(K) Number: K982826
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,literature
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 03/27/2020

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: Health Professional
• Device Model Number: 0800
• Device Catalogue Number: 0800
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/27/2020
• Initial Report FDA Received Date: 04/21/2020
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other