MAUDE Adverse Event Report: DORNIER MEDTECH SYSTEMS GMBH DORNIER GENESIS; UROLOGICAL TABLE

Model Number GENESIS

Device Problem Sticking (1597)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 12/06/2017

Event Type  malfunction  

Manufacturer Narrative

A service report completed and dated (b)(6) 2017 by a dmta field service engineer indicated that the device was confirmed to have a sticking footswitch pedal.When the top half of the footswitch was changed out, it was noted that either a cleaning agent or some other fluid had been exposed to the footswitch which was likely the cause of the sticking footswitch pedal.Soon after noticing the footswitch sticking, a member of the staff pressed the emergency shut off switch which tripped a facility electrical breaker that also required repair.After the footswitch top half was replaced, the device was found to be functioning within dornier specifications.The incident likely occurred due to the footswitch being exposed to a cleaning agent or some other fluid which caused a footswitch pedal to stick.As described in the genesis operator's manual, the customer was advised to use a protective cover on the footswtich to prevent further recurrence when the footswitch may be exposed to moisture and soiling.(b)(4).

Event Description

System continued to fluoro after doctor removed foot from fluoro footswitch button.

• Brand Name: DORNIER GENESIS
• Type of Device: UROLOGICAL TABLE
• Manufacturer (Section D): DORNIER MEDTECH SYSTEMS GMBH; argelsrieder feld 7; wessling, bavaria D-822 3; GM D-8223
• Manufacturer (Section G): DORNIER MEDTECH SYSTEMS GMBH; argelsrieder feld 7; wessling, bavaria D-822 3; GM D-8223
• Manufacturer Contact: chris felabom ; 1155 roberts blvd.; suite 100; kennesaw, GA 30144 ; 7705146106
• MDR Report Key: 7131083
• MDR Text Key: 95928950
• Report Number: 1037955-2017-00060
• Device Sequence Number: 1
• Product Code: JAA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K151485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/06/2017

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
• Device Operator: Physician
• Device Model Number: GENESIS
• Device Catalogue Number: K1034267
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 12/06/2017
• Device Age: 19 MO
• Event Location: Hospital
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/31/2016
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1