MAUDE Adverse Event Report: ERBE ELEKTROMEDIZIN GMBH ERBE; ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES

Model Number	20140-008
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/19/2018
Type of Reportable Event	Malfunction
Event or Problem Description
While doing a robotic assisted low anterior resection, this rn plugged in to erbe machine the cord to the motor stapler pack.Error message came up on robot monitor saying "bad connection".Second motor stapler pack opened, and plugged in as done with the first motor pack.This time a "non-recoverable fault subsystem failure" came up on robot monitor.Intuitive immediately called surgeon at surgeon console, and they were unable to move robot arms.Intuitive rep stated to remove all instruments from robotic arms ,and power down robot.Surgeon decided at this point to proceed with case laparoscopically.Robot then powered down per intuitive rep., along with erbe machine.Rep instructed this rn to then go behind erbe machine and turn it off, then back on, then to power robot back up.Intuitive rep then stated that erbe was communicating with robot again.

• Brand Name: ERBE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest parkway se; marietta GA 30067
• MDR Report Key: 7930075
• Report Number: 7930075
• Device Sequence Number: 16643834
• Product Code: GEI
• UDI-Device Identifier: 04050147018297
• UDI-Public: (01)04050147018297
• Combination Product (Y/N): N
• Initial Reporter State: RI
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date (Section B): 09/25/2018
• Report Date (Section F): 09/25/2018

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: 20140-008
• Device Catalogue Number: 20140-008
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2018
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/03/2018
• Patient Sequence Number: 1
• Date Report Sent to FDA: 09/25/2018