Catalog Number 8065752450 |
Device Problem
Mechanical Jam (2983)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/19/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A surgeon reported the shaft part of the vitrectomy probe got caught with the trocar and he was unable to pull out during a procedure.The stuck part was removed with the trocar.The procedure was completed after replacing the product with another one.There was no harm to the patient.This is one of two reports for this event.
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Manufacturer Narrative
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One opened 25 gauge (ga) trocar cannula/hub assembly attached to the probe needle in a tray was received.The sample was visually inspected and was found to be non-conforming with foreign material in the inner diameter (id) of the cannula.Prior to performing additional testing the trocar cannula was cleaned due to the presence of foreign material.The sample was then dimensionally inspected for cannula inner diameter and was found conforming.A functional fit test was performed with the returned probe and was found to be conforming.A review of the device history record traceable to the reported lot number indicates that the product was processed and released according to the product¿s acceptance criteria.The returned trocar sample was found to be visually non-conforming with foreign material in the cannula id; therefore, a product fit issue as described by the customer was confirmed.However, how and when the foreign material blocked the id of the cannula of the trocar could not be confirmed; therefore a root cause cannot be determined from the evaluation performed.No action was taken as the trocar was manufactured to specifications and the exact root cause for the foreign material in the id of the cannula is unknown.All trocar assemblies are 100% inspected for gage size.Any non-conformances found are removed from the lot and scrapped.The inspection includes evaluation for foreign material.The manufacturer internal reference number is: (b)(4).
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Manufacturer Narrative
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The previous report submitted for this event contained an error, in h.1.¿summary report¿ was inadvertently selected.After a recent systems update, a system error caused the inadvertent additional selection of ¿summary report¿ in h.1.On a select number of reports.The error, which was limited only to the h.1.Field, was promptly identified and quickly rectified.Correction smdrs are being filed for the impacted reports.This smdr is correcting that error for this event.The manufacturer internal reference number is: (b)(4).
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Search Alerts/Recalls
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