(b)(4).Batch # unk.The lot/batch was not provided; therefore, a manufacturing record evaluation could not be performed.Attempts are being made to obtain the following additional information and the device: can you please clarify if the clips that were fired out of the device were scissored (crossed)? or were the jaws of the device itself damaged (crossed)? were there any patient consequences? to date, no response has been provided.If the device or further details are received at a later date, a supplemental medwatch will be sent.
|