MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB; UNIT, ELECTROSURGICAL AND COAGULATION, WITH ACCESSORIES

Model Number	E6009
Medical Device Problem Codes	Energy Output Problem (1431); Inappropriate/Inadequate Shock/Stimulation (1574); Connection Problem (2900); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Electric Shock (2554); Unspecified Tissue Injury (4559); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/23/2024
Type of Reportable Event	Malfunction
Event or Problem Description
According to the reporter, during cholecystectomy surgery, the head nurse reported that the no.2 electrosurgical generator device currently used occasionally experienced no response to the foot pedal, which would affect the operation.If the foot pedal connection cable was fixed in one direction, it could be used normally.The department had prepared emergency backup electrosurgical generator as an emergency response.And contacted the equipment department personnel to arrive at the scene and waited for maintenance after the operation.After the equipment department staff arrived at the scene in time, they found that the connection cable at the root of the generator foot pedal had poor contact.Then cut off the connection line at the root of the pedal and re-welded and reinforced it, then the pedal could be used normally.Adverse event reported was electric shock.
Additional Manufacturer Narrative
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
New information has been received, and reassessment of the complaint found that it is no longer a reportable event.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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.
Event or Problem Description
According to the reporter, during cholecystectomy surgery, the head nurse reported that the no.2 electrosurgical generator device currently used occasionally experienced no response to the foot pedal, which would affect the operation.If the foot pedal connection cable was fixed in one direction, it could be used normally.The department had prepared emergency backup electrosurgical generator as an emergency response.And contacted the equipment department personnel to arrive at the scene and waited for maintenance after the operation.After the equipment department staff arrived at the scene in time, they found that the connection cable at the root of the generator foot pedal had poor contact.Then cut off the connection line at the root of the pedal and re-welded and reinforced it, then the pedal could be used normally.There was no patient injury.

• Brand Name: VALLEYLAB
• Common Device Name: UNIT, ELECTROSURGICAL AND COAGULATION, WITH 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: 19076459
• Report Number: 1717344-2024-00944
• Device Sequence Number: 5859739
• Product Code: BWA
• UDI-Device Identifier: 10884524000381
• UDI-Public: 10884524000381
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/07/2024
• 2 Devices were Involved in the Event: 1 2

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: E6009
• Device Catalogue Number: E6009
• Device Lot Number: 316386X
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2024
• Supplement Date Received by Manufacturer: 04/10/2024
• Initial Report FDA Received Date: 04/09/2024
• Supplement Report FDA Received Date: 05/07/2024
• Date Device Manufactured: 05/03/2017
• 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
• Patient Sex: Unknown