COVIDIEN MFG DC BOULDER LIGASURE XP; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
|
Back to Search Results |
|
Model Number LXMJ37S |
Device Problems
Energy Output Problem (1431); Difficult or Delayed Activation (2577)
|
Patient Problems
Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/20/2024 |
Event Type
malfunction
|
Event Description
|
According to the reporter, during a procedure, the device start-up sound and the end sound rang, but the sealing was inadequate/partial.It often takes longer than usual to complete the seal.The vessel was completely cut and bleeding observed directly from the ligasure seal.Since the bleeding could not be stopped, it was changed to lf1937 and the surgery was continued.Replaced with another device and it worked fine.
|
|
Manufacturer Narrative
|
D10 concomitant product: vlft10gen, vlft10gen ft series energy platformx1 (serial#: (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 donor nephrectomy procedure, the device start-up sound and the end sound rang, but the sealing was inadequate/partial.The good seals were completed immediately after the start of use, the sealing was completed, but it took a long time.The vessel was completely cut and bleeding observed directly from the ligasure seal.Bleeding was a small amount, it was not measured.No blood transfusion was performed.Since the bleeding could not be stopped, it was changed to lf1937 and the surgery was continued.The jaws was cleaned when burnt tissue adhered to it.The fine blood vessels around the kidney that contain fat.It grasped a lot of adipose tissue, but it was in the same range as the usual way of using it.Replaced with another device and it worked fine.There was no patient injury.
|
|
Manufacturer Narrative
|
Additional information: b5, g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.The evaluation found no potentially contributing factors, and the sample met all related specifications.It was reported that the there was difficult /intermittent activation and the seal was partial.The reported issue could not be confirmed.The most likely cause could not be identified because no related problem was detected with the device.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.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.
|
|
Search Alerts/Recalls
|
|
|