|
Model Number 176630 |
Device Problems
Detachment of Device or Device Component (2907); Noise, Audible (3273)
|
Patient Problems
No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 08/13/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, in the beginning of a laparoscopic cholecystectomy, the product was able to be use without any problems.When trying to clip the vessel on the way, a cracking sound was heard and the device was unable to be used.As a result of observing the inside of the abdominal cavity through a scope, a black shard that appeared to be a part of the clip tip was found and was collected by the surgeon.Another device was used to complete the case.The surgical time was extended by less than 30 minutes.There was no patient injury.
|
|
Manufacturer Narrative
|
Evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the instrument was received fully fired with no clips remaining within the tube shaft.The clip indicator was no longer active, jaws open and handle in neutral.A small fragment of metal was received with the instrument.Functionally, the instrument was engaged in the end of firing safety interlock.Instrument was disassembled in order to verify inner components.All components from gun were observed correct as per specification, and no anomalies were detected.It was reported that a component disengaged from the device into the surgical cavity and the device gave unexpected or uncharacteristic audible feedback of normal use.The reported issues were confirmed.The most likely cause could not be established from the information available.The manufacturing records for each device are thoroughly reviewed prior to release to ensure that it meets all medtronic quality specifications.A secondary review of the device history records found no potentially contributing factors.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.
|
|
Search Alerts/Recalls
|
|
|