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

Model Number VLFT10GEN

Device Problems Device Alarm System (1012); Energy Output Problem (1431)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 11/15/2023

Event Type  malfunction  

Event Description

According to the reporter, during a procedure, start-up sound and the end sound rung, but the sealing was inadequate/partial.When approached the blood vessel in order to seal it, the device activated, but the output stopped and hemorrhaging occurred before the seal was completed.Bleeding occur after the blood vessel completely cut.Bleeding observed directly from the device's seal.When bleeding occurred, a completion tone sounded and the dissection operation was performed.After that, about 4 seals were outputted, but an error sound was heard and the output stopped for all before the sealing were completed.At that time, there were no objects other than tissue was clamped in between (visual confirmation).After several continuous attempts, the device was able to be used as normal, so continued to use the device and had no problem after that.

Manufacturer Narrative

D10 concomitant product: lf1923, jaw open lf1923 ligasure maryland 23cm (lot#: 31440367x) 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 video-assisted thoracoscopic surgery respiratory surgery, the start-up sound and the end sound rung, but the sealing was inadequate/partial.When approached the small blood vessel about 3 millimeters, in order to seal it the device activated, but the output stopped and hemorrhaging occurred before the seal was completed.When bleeding occurred, a completion tone sounded and the dissection operation was performed.Bleeding occurred after the cut even though it seemed properly sealed.Bleeding observed directly from the ligasure seal.After that, about 4 seals were outputted, but an error sound was heard and the output stopped for all before the sealing were completed.At that time, there were no objects other than tissue was clamped in between (visual confirmation).After several continuous attempts, the device was able to be used as normal, so continued to use the device and had no problem after that.Due to the small amount of bleeding, only the hemostasis of electrocautery was performed and blood transfusion was not performed.The problem occurred at the time of the first activation was performed.It the first activation when the event occurred, so cleaning was not performed before that.The customer decided that there is no problem with the generator.

Manufacturer Narrative

Additional information: g3 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.

Manufacturer Narrative

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 video-assisted thoracoscopic respiratory surgery, the start-up sound and the end sound rung, but the sealing was inadequate/partial.When approached the small blood vessel about 3 millimeters, in order to seal it the device activated, but the output stopped and hemorrhaging occurred before the seal was completed.When bleeding occurred, a completion tone sounded and the dissection operation was performed.Bleeding occurred after the cut even though it seemed properly sealed.Bleeding observed directly from the ligasure seal.After that, about 4 seals were outputted, but an error sound was heard and the output stopped for all before the sealing were completed.At that time, there were no objects other than tissue was clamped in between (visual confirmation).After several continuous attempts, the device was able to be used as normal, so continued to use the device with the same generator and had no problem after that.Due to the small amount of bleeding, only the hemostasis of electrocautery was performed and blood transfusion was not performed.The problem occurred at the time of the first activation was performed.It the first activation when the event occurred, so cleaning was not performed before that.

• 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: 18311857
• MDR Text Key: 330292350
• Report Number: 1717344-2023-01516
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521548350
• UDI-Public: 10884521548350
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2023
• 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?: No
• Date Manufacturer Received: 12/20/2023
• 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.