APPLIED MEDICAL RESOURCES CD003, 5MM RETRIEVAL SYSTEM, 10/BX; LAPAROSCOPE, GENERAL & PLASTIC SURGERY
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Model Number CD003 |
Device Problem
Material Rupture (1546)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/04/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The event unit is not anticipated to return.A follow-up report will be provided upon completion of the investigation.
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Event Description
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Name of procedure: lap.Cholecystectomy.Detailed description of event: translation ame: to be able to retrieve the gallbladder, the incision was enlarged.During the retrieval the bag, as the user emphasizes, tore while pulling gently, in a place where experience has shown it to be very resistant to tearing.The bag has unfortunately been disposed of, but the customer will provide photos.The lot number also has to be provided still.Additional information received from applied medical representative via email on 07sep2020: the bag tore while removing the bag with the specimen inside.There was no contact with any instrument.The bag tore at the distal tip.The customer will provide a picture.The surgeon used his hand to pull on the cord loop.The surgeon used a new bag to remove the gallbladder.The lot is 1383620.Patient status: no patient status.Type of intervention: used a new bag to remove specimen.
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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 of a torn tissue bag could not be confirmed.In the absence of the event unit, it is difficult to determine if the fragmented tissue bag was caused by a device non-conformance.However, based on the description of the event, it is likely that the bag broke from the stress exerted on the bag while the specimen was being removed from the extraction site.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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Name of procedure: lap.Cholecystectomy.Detailed description of event: to be able to retrieve the gallbladder, the incision was enlarged.During the retrieval the bag, as the user emphasizes, tore while pulling gently, in a place where experience has shown it to be very resistant to tearing.The bag has unfortunately been disposed of, but the customer will provide photos.The lot number also has to be provided still.Additional information received from applied medical representative via email on 07sep2020: the bag tore while removing the bag with the specimen inside.There was no contact with any instrument.The bag tore at the distal tip.The customer will provide a picture.The surgeon used his hand to pull on the cord loop.The surgeon used a new bag to remove the gallbladder.The lot is 1383620.Patient status: no patient status.Type of intervention: used a new bag to remove specimen.
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Search Alerts/Recalls
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