APPLIED MEDICAL RESOURCES CTR03, 5X100 KII OPT ZTHR 6/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CTR03 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Unspecified Respiratory Problem (4464)
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Event Type
Injury
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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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Date of event: unknown.Procedure performed: unknown.Event description: incident occurred sometime between 07nov2021 and 13nov2021.Company representative states the procedure may have been a kidney transplant.What is known is that the procedure was around 400 minutes long.The customer complains the trocar seal was leaking.The patient's serum (b)(6) continued to rise significantly, delaying extubation, and requiring intensive care.The product was discarded at the hospital and is not available for return.Additional information received via email from user facility on (b)(6) 2021: physician states the seal inside one of the new trocars was leaking persistently, noting that several tanks of (b)(6) were used before realizing and swapping out the trocar.Physician also mentions, during the case, "the patient's serum (b)(6) continued to rise significantly, to the point that anesthesia was becoming concerned about his ventilation and it ended up delaying his extubating and requiring him to go to the icu.At the end of the case he had a significant amount of subcutaneous crepitus throughout the torso and upper extremities (from (b)(6))." type of intervention: patient required treatment in icu patient status: patient had significant amount of subcutaneous crepitus throughout the torso and upper extremities (from (b)(6)).
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Event Description
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Date of event: unknown.Procedure performed: unknown.Event description: incident occurred sometime between (b)(6) 2021 and (b)(6) 2021.Company representative states the procedure may have been a kidney transplant.What is known is that the procedure was around 400 minutes long.The customer complains the trocar seal was leaking.The patient's serum co2 continued to rise significantly, delaying extubation, and requiring intensive care.The product was discarded at the hospital and is not available for return.Additional information received via email from user facility on 16nov2021: physician states the seal inside one of the new trocars was leaking persistently, noting that several tanks of co2 were used before realizing and swapping out the trocar.Physician also mentions, during the case, "the patient's serum co2 continued to rise significantly, to the point that anesthesia was becoming concerned about his ventilation and it ended up delaying his extubating and requiring him to go to the icu.At the end of the case he had a significant amount of subcutaneous crepitus throughout the torso and upper extremities (from co2)." type of intervention: patient required treatment in icu.Patient status: patient had significant amount of subcutaneous crepitus throughout the torso and upper extremities (from co2).
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Manufacturer Narrative
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The event unit was not returned to applied medical for evaluation.As the event unit was not returned, applied medical is unable to determine if the event unit exhibited any non-conformances that could have contributed to seal leakage.Based on input received from applied medical clinical subject matter experts, it is unlikely that seal leakage would have caused or contributed to the patient outcome.Applied medical has reviewed the details surrounding the event and is unable to determine the cause of the injury or identify any reason why seal leakage could have caused or contributed to the injury.
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Search Alerts/Recalls
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