(b)(4).Batch # n90y93.The analysis results found that the mcm20 device (a) was received with a clip in the jaws.The instrument was noted to have the jaws open.In an attempt to replicate the event reported, the device was tested for functionality it was noted to have issues holding the clip on the jaw.The partially formed clip was a result of testing to determine the functionality of the anti-backup feature.Upon testing, the device was cycled and it fed and formed the remaining 8 clips as intended.In order to evaluate the condition of the internal components, the device was disassembled and the anti-backup lever was noted to be worn out.No conclusion could be reached as to what may have caused the reported incident.The batch history record was reviewed and no defects, ncr¿s or protocols related to the complaint, were found during the manufacturing process.
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