BECTON DICKINSON & CO. (SPARKS) INSTRUMENT PREPSTAIN TECAN US II REFURB; PROCESSOR, CERVICAL CYTOLOGY SLIDE, AUTOMATED
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Catalog Number 490407 |
Device Problem
Structural Problem (2506)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/25/2023 |
Event Type
malfunction
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Manufacturer Narrative
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E.1.Initial reporter phone #: (b)(6).H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that while using instrument prepstain tecan us ii refurb, the lid was falling and won't stay open.No patient impact reported.The following information was provided by the initial reporter: "tripath us ii - centrifuge two strut failure.The agent engineer, is in a hurry to give feedback.The centrifuge's support rod failed, but did not lose its support completely.There was no free fall, but a slow fall without injury.".
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Manufacturer Narrative
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H.6.Investigation summary: complaint reports lid failure on centrifuge associated with prepmate (catalog number 490407) serial number (b)(6).Complaint alleges centrifuge lid gas springs failure, no support for the lid to stay open.Customer advised no one was hurt or injured.Customer replaced the centrifuge and post intervention the centrifuge was operating normally.Root cause attributed to faulty lid gas springs.This complaint is a confirmed failure of the instrument based on the customer investigation.Dhr review is not required because the part that allegedly failed is not tested as part of the manufacturing process but is shipped separately and tested during installation.Review of risk management files confirms there are no new or modified risks associated with this failure mode.There are no corrective action plans or other corrections occurring.Bd quality will continue to monitor for trends associated with failure of "centrifuge.".
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Event Description
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It was reported that while using instrument pepstatin tecan us ii refurb, the lid was falling and won't stay open.No patient impact reported.The following information was provided by the initial reporter: "tripath us ii - centrifuge two strut failure the agent engineer, is in a hurry to give feedback.The centrifuge's support rod failed, but did not lose its support completely.There was no free fall, but a slow fall without injury.".
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