Catalog Number C-HSK-3043 |
Device Problem
Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 02/11/2019 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).A lot history record review was completed for the reported product lot number.There were no ncmr¿s for the reported lot number.The device has been returned to the factory and is being evaluated.A supplemental report will be submitted when the evaluation is completed.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using hs iii proximal seal system 4.3mm.They used two consecutive hsk-3043 that failed during the procedure.The proper steps were taken to load the devices, but they both failed to release themselves from the delivery portion.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Manufacturer Narrative
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Internal complaint # trackwise # (b)(4).Autonumber # (b)(4).The hsk device was returned to the factory for evaluation.Signs of clinical use and evidence of blood were observed.A visual inspection was conducted.The delivery device and seal were returned outside of the loading device.The seal was also returned outside of the delivery tube.Specks of blood were observed on the loading device and on the seal.No crack/delamination of seal was observed.The blue slide lock was dis-engaged and the white plunger was fully depressed on the delivery device.The following measurements were taken; the inner delivery tube diameter was measured at.198 in.The outer diameter was measured at.221 in.The length of the delivery tube was measured at 2.50 in.The values recorded were within the tolerance specifications.Based on the received condition of the device, the reported failure mode ¿activation problem; seal¿ was not confirmed but the analyzed failure mode ¿premature deployment" was confirmed.
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Event Description
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The hospital reported that during an endoscopic vein harvesting procedure using hs iii proximal seal sytem 4.3mm.They used two consecutive hsk-3043 that failed during the procedure.The proper steps were taken to load the devices, but they both failed to release themselves from the delivery portion.A replacement device was used to complete the procedure.The hospital did not report any patient effects.
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Search Alerts/Recalls
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