MAUDE Adverse Event Report: DEPUY SYNTHES PRODUCTS LLC SYSTEM CONSOLE,SINGLE PORT,W/IRRIGATION; MOTOR, DRILL, ELECTRIC - CONSOLE

Model Number	SC2101
Medical Device Problem Codes	Overheating of Device (1437); Device Displays Incorrect Message (2591)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	01/01/2017
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.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
This is event 2 of 2 of the same event.It was reported from (b)(6) that during a cholesteatoma ear, nose and throat surgical procedure, it was observed that the motor device had multiple intermittent failures and the console displayed an e8 system fault error code.It was further reported that a while later, the console displayed an e5 fault and was once again rectified by technician on-site.According to the reporter, this was also followed by smoke coming out from the console device which was presumed due to being over heated.The system was still functional after a pause of about 30 minutes.The e5 code was displayed two more times after which was noted due to loose connection between the handpiece and the console there was a thirty minute delays to the surgical procedure.It was reported that the case was completed using the same set.There was patient involvement.There were no injuries, medical intervention or prolonged hospitalization.The exact date of the event was not reported.All available information has been disclosed.If additional information should become available, a supplemental medwatch will be submitted accordingly.
Additional Manufacturer Narrative
It was documented in the initial report that the date of manufacture was unknown.It has been updated as jan 31, 2012.Therefore, udi is (b)(4).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 device cable/cord was damaged and the pc board did not function.It also failed pretest for air pump test.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.

• Brand Name: SYSTEM CONSOLE,SINGLE PORT,W/IRRIGATION
• Common Device Name: MOTOR, DRILL, ELECTRIC - CONSOLE
• Manufacturer (Section D): DEPUY SYNTHES PRODUCTS LLC; 4500 riverside drive; palm beach gardens FL 33410
• MDR Report Key: 7179782
• Report Number: 1045834-2018-50055
• Device Sequence Number: 1274470
• Product Code: HBC
• UDI-Device Identifier: 00845384011972
• UDI-Public: (01)00845384011972
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• 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
• Report Date (Section B): 12/12/2017

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: SC2101
• Device Catalogue Number: SC2101
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/08/2018
• Initial Date Received by Manufacturer: 12/12/2017
• Supplement Date Received by Manufacturer: 01/21/2018
• Initial Report FDA Received Date: 01/10/2018
• Supplement Report FDA Received Date: 01/25/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1