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Model Number SIGTRS45AMT |
Device Problems
Break (1069); Separation Failure (2547)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/12/2021 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic conducted an investigation based upon all information received.The device was available for evaluation.Visual inspection noted the device was found to be partially fired and a damage to the cutting edge of the knife blade was observed.It was reported that after firing, the reinforcement material did not release from the device as expected.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.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: when positioning the stapler on the application site, ensure that no obstructions, such as clips, are incorporated into the instrument jaws.Firing over an obstruction may result in incomplete cutting action and/or improperly formed staples.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 partial right pulmonary resection, when reload stapled the pulmonary parenchyma, the suture on the tip of the reload could not be cut, so the reinforcement sheet became unable to be removed from the pulmonary parenchyma.The surgeon cut the reinforcement sheet with scissors.There was no patient injury.
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Search Alerts/Recalls
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