MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FX8; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLFX8GEN

Device Problem Energy Spectrum Incorrect (1210)

Patient Problem Shock (2072)

Event Date 03/18/2024

Event Type  malfunction  

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.

Event Description

According to the reporter, during laparoscopic total hysterectomy plus double fallopian tube resection, the doctor was using the unipolar electric hook, the patient's body began to shake abnormally.The doctor immediately stopped using the device and monitored blood pressure, heart rate and other parameters.After ensuring that the parameters were stable and normal, replaced it with another high-frequency electrosurgical generator and continued to complete the surgery.

Manufacturer Narrative

Additional information: b5, g3.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 Description

According to the reporter, during laparoscopic total hysterectomy plus double fallopian tube resection, the doctor was using the unipolar electric hook, the patient's body began to shake abnormally.The doctor immediately stopped using the device and monitored blood pressure, heart rate and other parameters, after ensuring that the parameters were stable and normal, replaced it with another high-frequency electrosurgical generator and continued to complete the surgery.No medical intervention was required.It did not extended nor prolonged the patient's hospitalization.No blood transfusion required was needed.

• Brand Name: VALLEYLAB FX8
• Type of Device: 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: 19184707
• MDR Text Key: 341789849
• Report Number: 1717344-2024-01061
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521707306
• UDI-Public: 10884521707306
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K172757
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/06/2024

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
• Device Operator: Health Professional
• Device Model Number: VLFX8GEN
• Device Catalogue Number: VLFX8GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 04/02/2024
• Initial Date FDA Received: 04/25/2024
• Supplement Dates Manufacturer Received: 04/25/2024
• Supplement Dates FDA Received: 05/06/2024
• Date Device Manufactured: 02/06/2021
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 47 YR
• Patient Sex: Female