Model Number CD001 |
Device Problem
Difficult to Open or Close (2921)
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Patient Problem
Injury (2348)
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Event Type
malfunction
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Manufacturer Narrative
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No product is being returned for evaluation and no lot # has been provided to manufacturer.A final report will be sent once the results have been analyzed.
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Event Description
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Procedure performed: laparoscopic cholecystectomy.Dr performing a lap chole experienced issues with cd001.Dr has used this bag for many years.Dr was using cff03 and cor47 port, dr placed the gallbladder in the cd001 and pulled the string to tighten the bag ready for retrieval.Dr said the bag did not close correctly and it leaked bile into the abdomen resulting him in having to wash the abdomen with 6 litres of ns and the patient has had to stay in hospital with 2 drains post op.Dr said that this issue had occurred repeated itself 3 times now on separate occasion.The device was not kept due to its condition after the leak.Additional information received from sales rep via email on 02sep2019: i think i did state that the bag leaked at the bead end and did not close properly and did not burst in my original cer.Additional information received from sales rep via email on 19sep2019: he cannot remember when the other 2 times occurred unfortunately.Patient status: stayed in hospital for a number of days with 2 drains in abd complaining type of intervention: washed the abdomen with 6l of ns and patient had to stay in hospital with 2 drains post op.(b)(4).
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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, testing was unable to be performed and the complainant's experience could not be confirmed.In the absence of the event unit, it is difficult to determine the exact root cause of the event.At this time, applied medical is unable to confirm that a product malfunction occurred.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.Dr performing a lap chole experienced issues with cd001.Dr has used this bag for many years.Dr was using cff03 and cor47 port, dr placed the gallbladder in the cd001 and pulled the string to tighten the bag ready for retrieval.Dr said the bag did not close correctly and it leaked bile into the abdomen resulting him in having to wash the abdomen with 6 litres of ns and the patient has had to stay in hospital with 2 drains post op.Dr said that this issue had occurred repeated itself 3 times now on separate occasion.The device was not kept due to its condition after the leak.Additional information received from sales rep via email on 02sep2019: i think i did state that the bag leaked at the bead end and did not close properly and did not burst in my original cer.Additional information received from sales rep via email on 19sep2019: he cannot remember when the other 2 times occurred unfortunately.Patient status: stayed in hospital for a number of days with 2 drains in abd complaining.Type of intervention: washed the abdomen with 6l of ns and patient had to stay in hospital with 2 drains post op.(b)(4) 1 of 3, (b)(4) 2 of 3, (b)(4) 3 of 3.
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Search Alerts/Recalls
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