Model Number CA500 |
Device Problem
Failure to Align (2522)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit is anticipated to return to applied medical.A follow up report will be provided following the completion of the investigation.
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Event Description
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Procedure performed: laparoscopic cholecystectomy.Event description: "[institution] informed me of an incident today.Surgery was today with ca500.I will have more information tomorrow when i visit the account." additional information was received via email on 14sep2023 from [name], account manager iv, applied medical.It is unknown what was being sealed/clipped at the time of the event.The surgeon pulled the trigger plastic to plastic and no clip was delivered.Then the clips to follow the first activation began to scissor.The case was completed with a competitive clip applier.No known injury.Product is available for return.Patient status: no known injury.Intervention: the case was completed with a competitive clip applier.
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Manufacturer Narrative
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The event unit returned to applied medical for evaluation.Functional testing was performed on the event unit.The complainant¿s experience of clips scissoring could not be replicated or confirmed as the unit passed relevant functional testing and no visible non-conformances were observed.Applied medical has reviewed the details surrounding the event and related products and is unable to determine the cause of the reported event based on the evaluation of the returned unit.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: laparoscopic cholecystectomy.Event description: "[institution] informed me of an incident today.Surgery was today with ca500.I will have more information tomorrow when i visit the account.".Additional information was received via email on 14sep2023 from [name], account manager iv, applied medical.It is unknown what was being sealed/clipped at the time of the event.The surgeon pulled the trigger plastic to plastic and no clip was delivered.Then the clips to follow the first activation began to scissor.The case was completed with a competitive clip applier.No known injury.Product is available for return.Patient status: no known injury.Intervention: the case was completed with a competitive clip applier.
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Search Alerts/Recalls
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