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Model Number 176625 |
Device Problems
Mechanical Problem (1384); Material Deformation (2976)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/11/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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According to the reporter, during laparoscopic gallbladder procedure, the surgeon noticed that the clips got a little tangled, malformed and scissored.This means that the clips were not stuck but are very easy to remove.Another clip applier was used to complete the case.There was no patient injury.
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Manufacturer Narrative
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Additional information: g3, h3, h6 h3 evaluation summary: medtronic conducted an investigation based upon all information received.The device was not returned, but a photo was available for evaluation.A video was also provided.Visual inspection noted that two clips were seen applied to tissue.The partially applied clip was removed from the tissue using a grasping instrument.In an image: three clips appeared scissored.One clip did not properly formed and was in a tear drop shape.It was reported that the clips got a little tangled, malformed and scissored.The reported issues were 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 submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Search Alerts/Recalls
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