(b)(4).Batch #: unk.Attempts have been made to retrieve the device.To date the device has not been returned.If the device or further details are received at a later date a supplemental medwatch will be sent.The manufacturing records were reviewed and the manufacturing/packaging criteria were met prior to the release of this lot.Attempts are being made to obtain the following information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent: please clarify, per device, how the devices ¿misfired¿.Did device not feed clips? did device feed clips sideways? did device not fire clips (jammed)? did device fire malformed clips? did device fire scissored clips? did device drop or eject clips? if other, please specify: were there any patient consequences? if yes, please describe.If information is obtained that was not available for the initial report, a follow-up report will be filed as appropriate.
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