|
Model Number 176630 |
Device Problems
Break (1069); Entrapment of Device (1212); Mechanical Problem (1384); Detachment of Device or Device Component (2907); Mechanics Altered (2984)
|
Patient Problem
Unspecified Tissue Injury (4559)
|
Event Date 04/28/2021 |
Event Type
Injury
|
Manufacturer Narrative
|
The incident device has been received and is under evaluation.When the device evaluation is complete a follow-up report will be submitted.If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
According to the reporter, during a coelioscopic cholecystectomy, the device jammed, and the jaws were locked onto the tissue.There were malformed clips as well.A broken piece of metal from the body of the clip broke off and went into the patient's liver.The surgeon retrieved the piece of metal with forceps and had to do a thermocoagulation spot on the liver.There was tissue damage and unanticipated tissue loss as a result of this problem.The procedure time was extended for 10 minutes due to the product problem.The surgeon had to use another device to complete the procedure.
|
|
Manufacturer Narrative
|
Additional information: d9, g3, h3 (dev ret to mfr), 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
|
Evaluation summary: medtronic conducted an investigation based upon all information received.The device and a photo were available for evaluation.Visual inspection noted the driver of the component to be broken.It was reported that the clips did not load properly into the jaws as expected, a clip broke into pieces, the clips did not close completely and were malformed, a component disengaged from the device into the surgical cavity, and the jaws of the device remained closed on tissue after firing.The reported issues were confirmed.The most likely cause was traced to a component failure.The function of the driver is to advance through the jaw channel and make them close.When the driver moves backwards, jaw will open.When the driver is broken, the clips will not load properly into the jaws as expected.Internal process improvements have been initiated to mitigate this issue.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.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.
|
|
Search Alerts/Recalls
|
|
|