Model Number C3601 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
Event Type
malfunction
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Manufacturer Narrative
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An investigation has been initiated based on the reported information.Upon completion of the investigation, a follow-up report will be submitted.
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Event Description
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A facility reported that the cusa excel 36khz tubing set (c3601) was used in a tumorectomy procedure, and when the tube was attached to the main unit and primed, water leakage occurred near the irrigation pump before the procedure.Two cracks were confirmed in the product.Therefore, another product was used to complete the procedure.No surgical delay and adverse consequences to the patient were observed.
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Manufacturer Narrative
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Cusa excel 36khz tubing set (c3601) was not returned for evaluation and lot number information has not been provided; therefore, an evaluation of the device could not be performed, and device history record (dhr) could not be reviewed.The root cause(s) of the reported issue could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.
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Manufacturer Narrative
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The cusa excel 36khz tubing set (c3601) was returned for evaluation: failure analysis : the returned tube was tested for leakage condition by introducing water through the irrigation tube with a syringe.A leakage was observed in the irrigation tube (with blue strip).In addition, some scuff marks were observed in the area of the irrigation tube where the leak was observed.The damage observed in this section of the irrigation tube is consistent with the defect cause when the tube is incorrectly assembled into the pump latch, and it is pinched under compression.The reported condition of ¿leakage¿ was confirmed.Root cause : based on the unit evaluation, the root cause of the reported condition is related to an improper assembly of the tube into the console machine.The complaint investigation rules out any relationship of the reported condition with the product manufacturing process at integra.Trends will be monitored for this and similar issues.At present, we consider this complaint to be closed.The cusa excel user¿s guide provides the proper instructions for the tubing assembly into the console machine and has the following caution statement to avoid damages to the tube: ¿make sure that the irrigation tubing center between the v-shaped tubing retainers before you close the pump latch.Otherwise, the pump latch will pinch the tubing, preventing the flow of irrigation fluid.¿.
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Search Alerts/Recalls
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