Model Number 189623-01 |
Device Problems
Shipping Damage or Problem (1570); Manufacturing, Packaging or Shipping Problem (2975)
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Patient Problems
Blood Loss (2597); No Information (3190)
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Event Date 08/29/2019 |
Event Type
Injury
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Manufacturer Narrative
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A prostate brachytherapy procedure was performed by the hospital.Eighteen needles were placed in the prostate and the patient experienced bleeding.The hospital performed two surgeries to control the bleeding in the bladder and gave a blood transfusion.The investigation of this case is still on-going by elekta whom are awaiting further details from the hospital.Elekta is investigating what the relationship is between the bleed and the usage of the proguide needles and what procedure did the hospital follow.This case is the first case of this kind reported to elekta.
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Event Description
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Customer reported that they ordered proguide sharp needles for prostate brachytherapy but they instead received proguide round needles for prostate brachytherapy.The patient was bleeding during the treatment.The customer suggested a connection between the bleeding and the usage of the proguide needles.
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Manufacturer Narrative
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E2 updated.E3 updated.H6 updated.H10 updated: the investigation was completed by conducting a thorough evaluation of the reported information.It was ascertained that due to a human error, an incorrect order was placed in the ordering software, and round proguide needles were delivered instead of the sharp needles as requested by the customer.There are no indications that the patient injury is related to the use of a mix of round and sharp proguide needles during the application.The issue could not be investigated further because no detailed information regarding this application has been received from the hospital, despite a number of requests.
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Search Alerts/Recalls
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