Catalog Number 12773-02 |
Device Problem
Unsealed Device Packaging (1444)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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The device is expected to be returned for evaluation.It has not yet been received.A follow-up report will be submitted with all additional relevant information.
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Event Description
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It was reported that the prostyle outer pouch packaging was unsealed for about 2cm.The device was not used and there was no patient involvement.Another prostyle device was used to continue the procedure.There was no reported clinically significant delay in the procedure.No additional information was provided.
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Event Description
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Subsequently to the initially filed emdr additional information was received: after noting that the outer pouch was unsealed, the prostyle device was desterilized by the operator by opening the tray packaging.No additional information provided.
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Manufacturer Narrative
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Visual inspections were performed on the returned device.The reported 2cm unsealed device packaging could not be confirmed due to device condition.A review of the manufacturing records identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no similar incidents from this lot.The investigation was unable to determine a conclusive cause for the reported difficulties.Based on the information reviewed, there is no indication of a product quality issue with respect to manufacture, design or labeling of the device.
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Search Alerts/Recalls
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