MAUDE Adverse Event Report: COVIDIEN MFG DC BOULDER VALLEYLAB FT10; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number VLFT10GEN

Device Problem Energy Output Problem (1431)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/20/2024

Event Type  Injury  

Manufacturer Narrative

D10 concomitant products: lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot#30450162x); lf1937, jaw lap lf1937 ligasure maryland 37cm, (lot#31300279x); vlls10gen, vlls10gen ls series vessel sealing gen, (sn: (b)(6)).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.

Event Description

According to the reporter, during laparoscopic total hysterectomy with uni-bilateral adnexectomy, the device was not sealing the vessels properly on the cervical tissue.An activation tone was heard, no errors or alarms showed on the equipment, an end tone was heard and sealing was completed.After various attempts and increased uterine bleeding, the surgeon requested for another ligasure device which did not perform the cauterization.The generator was changed to ft10 and the surgeon was still not able to perform the uterine artery cauterization.The patient had a bleeding of 500-600 ml during the procedure and a suture with stratafix of the bilateral uterine arteries was performed because both ligasure were not effective in the cauterization, which extended the surgical procedure for 30 minutes, blood transfusion was no longer necessary.The jaws of the ligasure handpiece was cleaned whenever it was dirty.The vaginal reconstruction was not performed for patient's safety, which will be performed in another date after the full recovery of the patient from the surgery.

Event Description

According to the reporter, during laparoscopic total hysterectomy with uni-bilateral adnexectomy, the device was not sealing the vessels properly on the cervical tissue.An activation tone was heard, no errors or alarms showed on the equipment, an end tone was heard and sealing was completed.After various attempts and increased uterine bleeding, the surgeon requested for another ligasure device which did not perform the cauterization but had activation and end tone heard.The generator was changed to ft10 and the surgeon was still not able to perform the uterine artery cauterization.The patient had a bleeding of 500-600 ml during the procedure and a suture with stratafix of the bilateral uterine arteries was performed because both ligasure were not effective in the cauterization, which extended the surgical procedure for 30 minutes, blood transfusion was no longer necessary.The jaws of the ligasure handpiece was cleaned whenever it was dirty.The vaginal reconstruction was not performed for patient's safety, which will be performed in another date after the full recovery of the patient from 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.

• Brand Name: VALLEYLAB FT10
• 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: 18890597
• MDR Text Key: 337511126
• Report Number: 1717344-2024-00681
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521516328
• UDI-Public: 10884521516328
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/12/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VLFT10GEN
• Device Catalogue Number: VLFT10GEN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/20/2024
• Date Device Manufactured: 07/11/2019
• 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
• Treatment: SEE H11
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 43 YR