APPLIED MEDICAL RESOURCES C2A12, GELPOINT V-PATH PLATFORM, 9.5 CM; CULDOSCOPE (AND ACCESSORIES)
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Model Number C2A12 |
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 02/27/2023 |
Event Type
malfunction
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Manufacturer Narrative
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No product is being returned to applied medical for evaluation.A follow-up report will be provided upon completion of investigation.
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Event Description
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Procedure performed: hysterectomy with double adnexectomy, myomatous uterus.Event description: the revision of the cavity was being carried out, after removing the uterus and annexes, at that moment it was discovered that part of the trocar seal was loose inside.The part of the trocar that has detached (inner white plastic seal) is removed, a photo of the products is attached.The defective trocar is used during the entire intervention for optics in the six o´clock position.The hospital documents the case just by sending a photo and discards the device.Intervention: the part of the trocar that has detached (inner white plastic seal) is removed.Patient status: favorable.
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.However, a photo of the shield, an internal plastic component of the sleeve was provided, confirming the complainant¿s experience of shield dislodgement.Based on the description of the event, it is likely that the shield dislodgement was caused by non-axial insertion or removal of asymmetrical instrumentation through the sleeve.Applied medical¿s instructions for use (ifu) states that, "extra care should be taken when inserting and withdrawing angular and asymmetrical instruments, such as 'j' hooks and clip appliers." the ifu also states, "all instruments should be centered axially when inserted through the seal." the probability and criticality of harm resulting from this failure have been evaluated and were found to be at an acceptable level.
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Event Description
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Procedure performed: hysterectomy with double adnexectomy, myomatous uterus.Event description: the revision of the cavity was being carried out, after removing the uterus and annexes, at that moment it was discovered that part of the trocar seal was loose inside.The part of the trocar that has detached (inner white plastic seal) is removed, a photo of the products is attached.The defective trocar is used during the entire intervention for optics in the six o´clock position.The hospital documents the case just by sending a photo and discards the device.Intervention: the part of the trocar that has detached (inner white plastic seal) is removed.Patient status: favorable.
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