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

Model Number	E1455B
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Burn(s) (1757)
Date of Event	06/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during left axillary lymph node dissection, during dissection of tissue within surgical site, the electrode with the safety sleeve was pulled for a case.The scrub tech when realizing it was not compatible with the cvplp2000, attempted to cut the safety sleeve off, and then forced the electrode onto the bovie pencil with a pair of graspers or similar device and that tore the insulated lining on the bovie pencil, causing an alternate pathway for the electricity which caused the patient small 1 cm burn inside the surgical dissection site up to the edge of the incision.Items listed were replaced and items involved were sequestered in order to complete the case.The burn has been bandaged, and the patient is doing well with no concerns.
Additional Manufacturer Narrative
D10 concomitant products: cvplp2000, cvplp2000 vl single use smoke evacpencil (lot#:230806164x), vlft10gen, vlft10gen ft series energy platformx1 (serial#:(b)(6)), se3690, se3690 rapidvac smoke evacuator 110vx1 (serial#:(b)(6)), e7507, e7507 polyhesive ii rem ret el w/cord (lot#:unknown).Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
Additional Manufacturer Narrative
Additional information: g3, h3, h6 h3.Evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A visual inspection of the returned photo(s) noted damage to the insulation of the electrode.Without receiving the device, a detailed investigation could not be performed for the reported complaint.The damage to the insulation can lead to possible injury to the user and/or patient.It was reported that there was a device related burn.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: of insulation damage.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: do not modify or add to the insulation of active electrodes.Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.

• Brand Name: EDGE
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• Manufacturer (Section D): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer (Section G): COVIDIEN MFG DC BOULDER; 5920 longbow dr; boulder CO 80301 3299
• Manufacturer Contact: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 19735795
• Report Number: 1717344-2024-01472
• Device Sequence Number: 18236515
• Product Code: GEI
• UDI-Device Identifier: 10884521713208
• UDI-Public: 10884521713208
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K955836
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/18/2024

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 Model Number: E1455B
• Device Catalogue Number: E1455B
• Device Lot Number: 240500132R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/14/2024
• Supplement Date Received by Manufacturer: 09/03/2024
• Initial Report FDA Received Date: 07/12/2024
• Supplement Report FDA Received Date: 09/18/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: SEE H11
• Patient Sex: Unknown