MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; ELECTROSURGICAL, CUTTING & COAGULATION & ACCES

Model Number	E1504
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Full thickness (Third Degree) Burn (2696); Unspecified Tissue Injury (4559)
Date of Event	01/06/2022
Type of Reportable Event	Serious Injury
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 an atraumatic coronary artery bypass, the ligasure could not activate as there was an error message.The procedure was then continued with an electrode together with a competitor's pencil and a generator where it was reported that the competitor's pencil and the generator worked without being activated and that the pencil was warm.An electro surgical cut with no burnt edges was visible on the aorta that caused 1 liter of blood loss and had to be closed via suturing.
Event or Problem Description
According to the reporter, during an atraumatic coronary artery bypass, the device could not activate as there was an error message.The procedure was then continued with an electrode together with a competitor's pencil and a generator where it was reported that the competitor's pencil and the generator worked without being activated and that the pencil was very warm and red and reported that it came from the extension.During the procedure, the pen was kept in a material bag in the abdomen and neck.It was reported that there were fire wounds in the patient on the abdomen and in the neck.Device was used several times.Spontaneous activation of the coagulation pen (when not in use) during the procedure whereby coagulation pen became hot and smoke was also determined.An electrosurgical cut with no burnt edges was visible on the aorta that caused 1 liter of blood loss and had to be closed via suturing.Patient had a 7 to 8-1/2 cm and 3-4 cm and 1-2 cm third-degree burn at the abdomen treated with standard treatment.Surgical field was dry.
Additional Manufacturer Narrative
Additional information: if information is provided in the future, a supplemental report will be issued.
Additional Manufacturer Narrative
Additional information: a3, b2(intervention req), d10, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that there was an adverse event without an identified device or use problem.A potentially related device issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided 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.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.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.

• Brand Name: VALLEYLAB
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCES
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 13314391
• Report Number: 1717344-2022-00072
• Device Sequence Number: 1561887
• Product Code: GEI
• UDI-Device Identifier: 10884524001333
• UDI-Public: 10884524001333
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: PREAMEND
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/28/2022

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 Model Number: E1504
• Device Catalogue Number: E1504
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/06/2022
• Supplement Date Received by Manufacturer: 02/15/2022; 04/15/2022
• Initial Report FDA Received Date: 01/21/2022
• Supplement Report FDA Received Date: 03/10/2022; 04/28/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PENCIL
• Outcome Attributed to Adverse Event: Life Threatening; Other; Required Intervention
• Patient Sex: Male