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Model Number OMS-T10BT |
Device Problems
Mechanical Problem (1384); Gas/Air Leak (2946); Material Deformation (2976); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Tissue Injury (4559)
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Event Date 03/18/2024 |
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 a laparoscopic appendectomy procedure, at the time of inserting the trocar, the balloon leaked or deflated and could not be fixed on the skin.It was also noted that the balloon was distorted or had an unusual shape.A new device was used to resolve the issue, and an additional operation was performed to correct the problem.
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Search Alerts/Recalls
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