MAUDE Adverse Event Report: AUTOLUBE-III; MOTOR, SURGICAL INSTRUMENT, AC-POWERED

Model Number	AUTOLUBE-III
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.
Event or Problem Description
It was reported from (b)(6) that the foot control device was leaking oil.It was not reported if the device was used in surgery, or if there was patient involvement.It was not reported if there were any delays in the surgical procedure, or if a spare device was available for use.It was not reported if there were any injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
This device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the device failed pretest for oil leak inspection due to worn out seals.It was noted that the air intake was loose on the device.Therefore, the reported condition was confirmed.The assignable root cause was determined to be due to wear from normal use and servicing.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
The device manufacture date was documented as may 03, 2002 in the initial report in error.The device manufacture date has been updated to may 06, 2002.Therefore, udi has been updated accordingly.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Device was used for treatment, not diagnosis.The device availability was documented as december 15, 2017 in the initial report.The date returned to manufacturer was corrected to december 05, 2017.If additional information should become available, a supplemental medwatch report will be submitted accordingly.

• Brand Name: AUTOLUBE-III
• Common Device Name: MOTOR, SURGICAL INSTRUMENT, AC-POWERED
• MDR Report Key: 7125998
• Report Number: 1045834-2017-50198
• Device Sequence Number: 13805577
• Product Code: GEY
• UDI-Device Identifier: 00845384000396
• UDI-Public: (01)00845384000396(11)020503
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K970530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 11/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: AUTOLUBE-III
• Device Catalogue Number: AUTOLUBE-III
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2017
• Initial Date Received by Manufacturer: 11/30/2017
• Supplement Date Received by Manufacturer: 12/15/2017; 01/03/2018; 03/28/2018
• Initial Report FDA Received Date: 12/18/2017
• Supplement Report FDA Received Date: 01/11/2018; 02/01/2018; 03/28/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1