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

Model Number	20132-214
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	11/04/2019
Type of Reportable Event	Malfunction
Event or Problem Description
When we plugged in to test the apc straight fire message box appeared on the erbe machine stating device not connected.We reconnected, unplugged, reconnected and had the same issue.Switched out erbe machine-same message appeared-opened another straight fire and it worked.

• Brand Name: ERBE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest pkwy se; marietta GA 30067
• MDR Report Key: 9426197
• Report Number: 9426197
• Device Sequence Number: 2237226
• Product Code: GEI
• UDI-Device Identifier: 04050147013902
• UDI-Public: (01)04050147013902
• 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): 11/18/2019
• Report Date (Section F): 11/18/2019

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: 20132-214
• Device Catalogue Number: 20132-214
• Device Lot Number: 132348
• Was the Report Sent to FDA?: Yes
• Event Location: Hospital
• Date Report to Manufacturer: 12/06/2019
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 12/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Date Report Sent to FDA: 11/18/2019