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Model Number 174006 |
Device Problems
Positioning Failure (1158); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Laceration(s) (1946)
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Event Date 03/24/2024 |
Event Type
malfunction
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Event Description
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According to the reporter, during a laparoscopic sacrofixation procedure, after fixating the one side of the mesh into the promontor yle, the two tacking devices became blocked.To resolve the issue, the surgeon extended the incision by less than one inch and used suture to fix the other side of the mesh.This led to 30 minutes or more extended surgical time.
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Manufacturer Narrative
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D10 concomitant product: 174006, 174006 protack 5mm disp in (lot#p2l0520) 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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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 available for evaluation.Functionally, the instrument was applied to the appropriate test media.The remaining seventeen tacks deployed but did not seat properly.It was reported that the two tacking devices became blocked.The reported issue was confirmed.The product analysis noted evidence that the device was not used as intended.This issue is caused by an instrument that has been exposed to excessive force while applying helixes to a surface.If a helix is fired over improper surfaces it can provoke the exertion of excessive force to the handle causing the unit to disrupt the timing and to a possible jam.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: do not use the instrument on tissue(s) which cannot be inspected visually for hemostasis.A minimum of 4 mm tissue thickness is required when applying the helical fastener over underlying bone, vessels, or viscera.This device should not be used in tissues that have a direct anatomic relationship to major vascular structures.This would include the deployment of helical fasteners in the diaphragm in the vicinity of the pericardium, aorta or inferior vena cava during diaphragmatic hernia repair.Do not use in ischemic or necrotic tissue.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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