On (b)(6) of 2018, the user facility reported the following to richard wolf medical instruments (rwmic): for about 1-1.5 years the facility has had a difficult time thoroughly cleaning the motor hand pieces (part number 8565.021); tissue is found within the device even after extensive cleaning.On (b)(4) 2018 the sales representative reported that had visited the facility on (b)(4) of 2018, to walk through the device cleaning process.After cleaning the device themselves, the sales representative observed that there was tissue left inside the hand piece.Motor hand piece (part number 8564.021/serial number (b)(4)) - mdr 1418479-2018-00044.Motor hand piece (part number 8564.021/serial number (b)(4)) - mdr 1418479-2018-00045.Motor hand piece (part number 8564.021/serial number unknown) - event date (b)(6) 2018 - mdr 1418479-2018- 00046.Motor hand piece (part number 8564.021/serial number unknown) - event date (b)(6) 2018 - mdr 1418479-2018- 00047.All other unknown occurrences will be captured in mdr 1418479-2018-00048.Will the device be returned? yes.Was the device being used during a procedure when the issue occurred? no.Specifically, was the device being used on a patient when the issue occurred? no.Was there any injury or illness to patient or other personnel due to issue? n/a.Did the issue cause a delay in the procedure being performed that put the patient at risk? n/a.Was there a similar back-up device available for use? n/a.Was the scheduled procedure completed? n/a.How was the patient anesthetized? not applicable.
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