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

Model Number VLFT10GEN

Device Problems Energy Output Problem (1431); No Apparent Adverse Event (3189)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/11/2023

Event Type  malfunction  

Manufacturer Narrative

Concomitant product: lf1944, jaw lap lf1944 ligasure maryland 44 cm (lot#: 21950136x) 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.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, intra-operatively, the device's handpiece was plugged in correctly and was used with two different generator (switched handpiece to different generator after initial issues with sealing as part of troubleshooting) however the amount of energy being delivered to tissue was inconsistent with normal device functioning.A small amount of energy appeared to be delivered to tissue upon activation, as evidenced by steam and bubbling of tissue in between jaws, but was not sufficient to create a seal.Tissue type was fat along the greater curvature of the patient's stomach.Multiple activations did nothing to fix the partial sealing.There was no re-grasp alert but there was an end tone heard and an evidence of any energy delivery.Sales rep have followed up with hcp regarding patient and confirmed no complications or additional bleeding due to device.There was no medical or surgical intervention needed.There was no patient injury.

Event Description

According to the reporter, during laparoscopic sleeve gastrectomy, the ligasure handpiece was plugged in correctly and was used with two different generators (switched handpiece to different generator after initial issues with sealing as part of troubleshooting) however the amount of energy being delivered to tissue was inconsistent with normal device functioning.The device was new out of the box when the issue was discovered, a small amount of energy appeared to be delivered to tissue upon activation, as evidenced by steam and bubbling of tissue in between jaws but was not sufficient to create a seal.Tissue type was fat along the greater curvature of the patient's stomach, less than 7mm in thickness.Multiple activations did nothing to fix the partial sealing.There was no regrasp alert but there was an end tone heard and an evidence of any energy delivery.There were no complications or additional bleeding due to device.There was no medical or surgical intervention needed.Ligasure was plugged in to quadrant 4, electrosurgical pencil plugged into port 1 with cut set to 40 and coag set to 40, electrosurgical pencils were operating normally.A new ligasure was tried with the two generators and worked fine.There was no patient injury.

Manufacturer Narrative

Additional information: g3 correction: b5, h6 new information has been received, and reassessment of the complaint found that it is no longer a reportable issue.The event is no longer associated with a serious injury or potential for serious injury with reoccurrence.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.

• Brand Name: VALLEYLAB FT10
• Type of Device: 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: justin ellis ; 8200 coral sea st ne; mounds view, MN 55112 ; 7635265677
• MDR Report Key: 16250162
• MDR Text Key: 308498728
• Report Number: 1717344-2023-00114
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521548350
• UDI-Public: 10884521548350
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151649
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2023
• Is this an Adverse Event Report?: No
• 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: 03/23/2023
• 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 NOTE ON H10.