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

Model Number LF4418

Device Problems Break (1069); Peeled/Delaminated (1454); Difficult to Open or Close (2921); Protective Measures Problem (3015)

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

Event Date 03/25/2022

Event Type  malfunction  

Manufacturer Narrative

Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the unit had a knife trapped in track and was unable to retract.It was reported that the device broke during use.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue may occur when the blade is extended and the jaws are not completely closed.This allows the knife track to open too wide and the blade moves out of its track.As a safety measure, the knife must be retracted in order to open the jaws.The tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open.More frequent cleaning could have also reduced the difficulty activating the knife.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during the device's first use, the coating located inside the clamp had became unadapted.Nothing got detached from the device.As a result, a second device was opened to compensate for this malfunction.There was no patient injury.Medtronic initial investigation found that the knife was trapped and exposed on the side of the jaws.The jaws would not open or close due to the trapped knife.

Event Description

According to the reporter, during the device's first use, the coating located inside the clamp got separated but nothing got detached from the device.As a result, a second device was opened to compensate for this malfunction.There was no patient injury.Medtronic initial investigation found that the knife was trapped and exposed on the side of the jaws.The jaws would not open or close due to the trapped knife.

Manufacturer Narrative

Additional information: b5, g3, h6 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

Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the knife was trapped and exposed on the side of the jaws.The jaws would not open or close due to the trapped knife.Functionally, knife trap happens when the blade was extended and the jaws are not completely closed.This allows the knife track to open too wide and the blade moves out of its track.As a safety measure, the knife must be retracted in order to open the jaws.The tissue in the webbing may have prevented the knife from retracting far enough to allow the jaws to open.More frequent cleaning could have also reduced the difficulty activating the knife.It was reported that the insulation of the device was damaged.The reported issue could not be confirmed.The most likely cause could not be established from the information available.The evaluation detected an unreported condition: the unit had a knife trapped in track and was unable to retract.The product analysis noted evidence that the device was not used as intended.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.The instructions included with this device provide the following guidance: confirm that the jaws have reached the closed position and are locked (the handle is latched) before activating the cutter.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.

• Brand Name: LIGASURE IMPACT
• 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: tracy landers ; 5920 longbow drive; boulder, CO 80301 ; 3035816943
• MDR Report Key: 14472976
• MDR Text Key: 292400901
• Report Number: 1717344-2022-00624
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 10884521612525
• UDI-Public: 10884521612525
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K162047
• 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,Followup
• Report Date: 07/22/2022

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: LF4418
• Device Catalogue Number: LF4418
• Device Lot Number: 13280096X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2022
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/06/2022
• Initial Date FDA Received: 05/23/2022
• Supplement Dates Manufacturer Received: 06/15/2022; 07/21/2022
• Supplement Dates FDA Received: 06/28/2022; 07/22/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/06/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1