MAUDE Adverse Event Report: POWER TOOLS : THE ANSPACH EFFORT LLC CONSOLE, ELECTRIC, WITH IRRIGATION; MOTOR, DRILL, ELECTRIC - CONSOLE

Model Number	SC3002
Medical Device Problem Code	Vibration (1674)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/26/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Reporter's phone number: (b)(6).As of this date, the device has not been returned for evaluation; therefore, the reported condition cannot be confirmed and/or duplicated.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Event or Problem Description
It was reported from (b)(6) that during an unspecified surgical procedure, it was discovered that the console device had a lot of vibration.It was reported that the event occurred during use on a patient.It was not reported if there were any delays to the surgical procedure.It was reported that the same device was used to complete the surgery.There was patient involvement reported.There were no reports of injuries, medical intervention or prolonged hospitalization.All available information has been disclosed.If additional information should become available, a supplemental medwatch report will be submitted accordingly.
Additional Manufacturer Narrative
The actual device has been returned and is currently pending evaluation.Once reliability engineering evaluates the device, a supplemental medwatch report will be sent accordingly.
Additional Manufacturer Narrative
Incorrect device manufacture date: the device manufacture date was incorrect in the initial report.The device manufacture date has been updated from 6/24/2014 to 1/20/2015.The udi has been updated accordingly.Device evaluation: this device was returned for service; however, did not meet manufacturing specifications during pre-repair assessment.During repair, it was determined that the reported condition was not confirmed.Therefore, an assignable root cause was not determined.However, during evaluation, a visual and functional assessment was performed on the device which found that it displayed an a-1 error when the pump was turned on.It was further determined that the bezel was damaged and the cover was bent.It was determined that the type of damage was indicative of the device being dropped, user error.If information is obtained that was not available, a follow-up medwatch will be filed as appropriate.

• Brand Name: CONSOLE, ELECTRIC, WITH IRRIGATION
• Common Device Name: MOTOR, DRILL, ELECTRIC - CONSOLE
• Manufacturer (Section D): POWER TOOLS : THE ANSPACH EFFORT LLC; 4500 riverside drive; palm beach gardens 33410
• MDR Report Key: 7049609
• Report Number: 1045834-2017-50015
• Device Sequence Number: 1690882
• Product Code: HBC
• UDI-Device Identifier: 00845384017448
• UDI-Public: (01)00845384017448(11)140624
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K133604
• 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
• Report Date (Section B): 10/27/2017

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: SC3002
• Device Catalogue Number: SC3002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/11/2017
• Initial Date Received by Manufacturer: 10/27/2017
• Supplement Date Received by Manufacturer: 12/11/2017; 01/19/2018
• Initial Report FDA Received Date: 11/21/2017
• Supplement Report FDA Received Date: 12/15/2017; 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1