PROTEK MEDICAL PRODUCTS, INC. STERILE DISPOSABLE ENDOCAVITY NEEDLE GUIDE FOR ESAOTE EC123 PROBE; ENDOCAVITY (TRANS-RECTAL) BIOPSY NEEDLE GUIDE
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Model Number 5145 |
Device Problem
Loss of or Failure to Bond (1068)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 01/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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After being informed about the event, protek verified the existing inventory of the ref#(b)(4) and similar design needle guides.The inspection results show no loose cannula in any of the tested needle guides.Protek contacted the distributor and requested the used needle guide to be returned to us for evaluation, and asked for additional information to determine if the end user used the device per intended use (find out if the single-use device has been use more times, or have been re-sterilized, which would be outside of the labeling indications).Protek still waiting for responses.Note: this needle guide design has been on the market for over 10 years with no issues reported.Device not send back to us.
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Event Description
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An incident occured with device ref (b)(4), lot# 72335, exp 06.2021, on (b)(6) 2017.Incident concerns escaping of the metal cannula from its guide during the device use for prostate biopsy on a (b)(6) year old patient.Device was used and no further consequence have been notified, no patient injuries.
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Search Alerts/Recalls
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