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

Model Number 20132-218

Device Problems Detachment Of Device Component (1104); Device Or Device Fragments Location Unknown (2590)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/20/2017

Event Type  malfunction  

Event 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
• Type of Device: ELECTROSURGICAL, CUTTING &; COAGULATION &; ACCESSORIES
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; john tartal; 2225 northwest pkwy se; marietta GA 30067
• MDR Report Key: 6947480
• MDR Text Key: 89248365
• Report Number: 6947480
• Device Sequence Number: 1
• Product Code: GEI
• UDI-Device Identifier: 04050147014022
• UDI-Public: (01)04050147014022
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/03/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/13/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: 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
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 10/03/2017
• Device Age: 0 YR
• Event Location: Hospital
• Date Report to Manufacturer: 10/03/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 75 YR
• Patient Weight: 103