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Model Number VLOCL0326 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/04/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Concomitant medical products: vlocl0326, vlocl0326 v-loc* 180 0 grn 45cm gs21x12 (lot#a3j2009vy) 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.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 myomectomy, when suturing the uterus, there was a separation of two needles and thr eads. re-suturing was made to resolve the issue.There was no patient injury.
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Search Alerts/Recalls
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