Catalog Number 137081 |
Device Problems
Difficult To Position (1467); Activation, Positioning or Separation Problem (2906)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 07/01/2017 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
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Event Description
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During a mammary collection, the clips were cutting the collateral artery this resulted in the appearance of mammary hematomas.Devices changed with not great success.In follow up it was noted: the hematomas appeared because of the shear of the mammary collaterals.There was no medical intervention necessary.The patient's condition was reported as fine.
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Manufacturer Narrative
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(b)(4).The dhr for the instrument in question, was reviewed and found complete without any irregularities.This instrument was manufactured at the (b)(6) facility as part of a 99pc.Lot in (b)(6) of 2016.Evaluation of the returned instrument showed that the tips are aligned properly in the open and closed position, but in the open position the tip gap is slightly undersized to print specifications, which makes the clips tips slightly bowed in and not parallel to each other after loading.All instruments are 100% visually inspected and function tested at this facility prior to shipping since this is a standard procedure.We are unable to determine what caused the tip set to be undersized at the customer's site; although mishandling during use or at the cleaning and sterilization process is suspected.Per fda guidelines for manufacturers which state: "manufacturers are required to report to the fda when they learn that any of their devices may have caused or contributed to a death or serious injury.Manufacturers must also report to the fda when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or other remarks: serious injury if the malfunction were to recur." this incident is not reportable at this time with the information provided.No corrective action taken at this time.
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Event Description
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During a mammary collection, the clips were cutting the collateral artery this resulted in the appearance of mammary hematomas.Devices changed with not great success.In follow up it was noted: the hematomas appeared because of the shear of the mammary collaterals.There was no medical intervention necessary.The patient's condition was reported as fine.
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Search Alerts/Recalls
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