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

Model Number GENESIS

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Radiation Exposure, Unintended (3164)

Event Date 05/26/2017

Event Type  Injury  

Manufacturer Narrative

A service report completed and dated 06/02/2017 by a (b)(4) field service engineer indicated that the device was in compliance with dornier specifications.The system activity and error logs were checked and no errors were noted at time of the customer reported problem.While at the customer site, the customer stated to the fse that the footswitch was being depressed by something resting on top of it at the time of the incident.It's likely the customer had tried to press the motion stop buttons located on the unit and remote which would have stopped the table movement, but would have had no effect on the fluoroscopy.Had the customer pressed the emergency stop located mounted the wall, the fluoroscopy would have stopped immediately.All emergency stop buttons were found to be in proper working condition.No fault found with the device as manufactured.Device was found to be functioning within dornier specifications.The incident occurred due to user error during operation of the system.(b)(4).

Event Description

The customer reported that during a case they could not get the machine to stop.They tried 3 emergency stop buttons, but none of them worked.The patient received extra radiation on their shoulder.

• Brand Name: DORNIER GENESIS
• Type of Device: UROLOGICAL TABLE
• Manufacturer (Section D): DORNIER MEDTECH SYSTEMS GMBH; argelsrieder feld 7; wessling, bavaria D-822 34; GM D-82234
• Manufacturer (Section G): DORNIER MEDTECH SYSTEMS GMBH; argelsrieder feld 7; wessling, bavaria D-822 34; GM D-82234
• Manufacturer Contact: heather jenkins ; 1155 roberts blvd.; suite 100; kennesaw, GA 30144 ; 7705146123
• MDR Report Key: 6651593
• MDR Text Key: 77913617
• Report Number: 1037955-2017-00021
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/30/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: GENESIS
• Device Catalogue Number: K1034267
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 05/30/2017
• Device Age: 2 YR
• Event Location: Hospital
• Initial Date Manufacturer Received: 05/30/2017
• Initial Date FDA Received: 06/19/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/31/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other