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Model Number 134053 |
Device Problems
Mechanical Problem (1384); Detachment of Device or Device Component (2907); Mechanics Altered (2984); Noise, Audible (3273)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 06/11/2020 |
Event Type
malfunction
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Manufacturer Narrative
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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 an open procedure, deformed clips were noted.The surgeon had to take out the deformed clips out of the patient via tweezers.Another device was used to complete the case.
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Event Description
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According to the reporter, while clipping the little vessels on the liver, the surgeon could not squeeze the clip applier as usual.There was some noise that was different to the normal use.The clips came out unequally and fell into the patient¿s abdomen.The surgeon used a forcep to take out the deformed clips from the patient¿s cavity.Blood loss was also noted but not more than 500cc, and the surgical time was extended for 2 minutes.Another device was used to complete the case.There was no patient injury.
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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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Manufacturer Narrative
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H3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the jaws of the instrument were received out of alignment.It was reported that the clips did not close completely, malformed and did not load properly into the jaws as expected.A component was disengaged/disassociated 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 product analysis noted evidence that the device was not used as intended.This issue can occur if the distal end of the device was subjected to excessive manipulation during application of the instrument.The manufacturing records for each device are also 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.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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