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Model Number 8886848813 |
Device Problems
Difficult or Delayed Positioning (1157); Device Slipped (1584); Detachment of Device or Device Component (2907)
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Patient Problems
Hemorrhage/Bleeding (1888); Unspecified Tissue Injury (4559)
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Event Date 08/19/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).If information is provided in the future, a supplemental report will be issued.
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Event Description
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According to the reporter, during a laparoscopic living donor kidney minimal invasive procedure, on the removal of the kidney by clipping the branch aorta, the clips could not be triggered correctly, the clips fell into the patient cavity and was retrieved.There was an unanticipated tissue loss as a result of this problem and the bleeding vessel was overstitched to resolve the issue.It was noted that the age of the instrument was quite old and was used and sterilized very often.
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Manufacturer Narrative
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Additional info: event.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.
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Event Description
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According to the reporter, during a laparoscopic living donor kidney minimal invasive procedure, on the removal of the kidney by clipping the branch aorta, the clips could not be triggered correctly, there was a little resistance and the firing was completed.The clips did not hold tightly to the vessel and detached and fell into the patient cavity and was retrieved.There was an unanticipated tissue loss as a result of this problem and the bleeding vessel was overstitched to resolve the issue.It was noted that the age of the instrument was quite old and was used and sterilized very often.
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Manufacturer Narrative
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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 clip did not hold tightly to the vessel and detached, a component disengaged from the device into the surgical cavity and the instrument was difficult to fire but completed the firing sequence.The reported issues 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.The instructions included with this device provide the following guidance: reusable devices must be carefully inspected prior to and after each use, as any damage may affect the safe operation of the device.Failure to lubricate the device prior to sterilization may cause malfunction such as jamming, difficult operation, or unacceptable staple formation.Failure to fully squeeze the handle may result in miss-formed clips which may result in incomplete closure and lack of hemostasis.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.
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Search Alerts/Recalls
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