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

Model Number	20132-218
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/20/2017
Type of Reportable Event	Malfunction
Event or Problem Description
The circumferential cautery probe was placed in the patient through enteroscopy scope and several cautery applications were done.The probe was removed and the tip was wiped down per procedure.The probe was then place in the scope again.When the tip was visualized, the tip of the probe was gone.The probe was removed from the field and given to clinical engineering.When questioned further, the author of the internal report stated that the surgeon was sure the missing portion of the tip detached when the instrument was being wiped down, and that it had not fallen in the patient.There was no harm to the patient and the procedure was completed as planned.

• Brand Name: ERBE
• Common Device Name: ELECTROSURGICAL, CUTTING &; COAGULATION &; ACCESSORIES
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; john tartal; 2225 northwest pkwy se; marietta GA 30067
• MDR Report Key: 6947480
• Report Number: 6947480
• Device Sequence Number: 11040624
• Product Code: GEI
• UDI-Device Identifier: 04050147014022
• UDI-Public: (01)04050147014022
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/03/2017
• Report Date (Section F): 10/03/2017

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: Physician
• Device Expiration Date: 01/02/2022
• Device Model Number: 20132-218
• Device Catalogue Number: 20132-218
• Device Lot Number: 98262
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 10/13/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 103
• Date Report Sent to FDA: 10/03/2017