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Model Number 176630 |
Device Problems
Display or Visual Feedback Problem (1184); Mechanics Altered (2984)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2022 |
Event Type
malfunction
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Manufacturer Narrative
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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 laparoscopic colon resection, for vascular ligation, the clip was loaded into the jaws without any problem for the initial 5-6 shots but the clip would not load halfway through even when the handle was gripped.After hitting from the outside, the handle was gripped again to try the loading but device would not load.The counter was also not displayed properly.Another clip applier was used to resolve the issue in order to complete the case.When the handle was collected, display was still lit and showing 9 clips left.There was no patient injury.
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Manufacturer Narrative
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Additional information: d9, g3, h6, h3: evaluation summary: medtronic conducted an investigation based upon all information received.The device and two photos were available for evaluation.Visual inspection noted that the instrument was fully fired with no clips remaining within the tube shaft, the clip counter was not active, the jaws were open, the handle was in neutral and a properly formed clip was received in a small bag.No abnormalities were observed.Functional testing noted that the instrument was engaged in the end of firing safety interlock.The instrument handle was disassembled for visualization of internal components, revealing a proper handle assembly.The counter arm was properly seated within handle.An rpa representative battery was assembled onto the subject counter and the counter was manually indexed without issues multiple times.It was reported that the clips did not load properly into the jaws as expected and the digital reader did not work properly as intended.The reported issues could not be 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.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.
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Search Alerts/Recalls
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