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

Model Number 20132-218

Device Problem Material Protrusion/Extrusion (2979)

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

Event Date 04/11/2019

Event Type  malfunction  

Event Description

While using the erbe argon gas cautery machine on the pulmonary setting with the circumferential fire flexible wand it was noted that a 1cm uncovered wire was sticking out the end.

• Brand Name: ERBE
• Type of Device: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest parkway se; marietta GA 30067
• MDR Report Key: 8577256
• MDR Text Key: 143989467
• Report Number: 8577256
• Device Sequence Number: 1
• Product Code: GEI
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/03/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 20132-218
• Device Catalogue Number: 20132-218
• Device Lot Number: 85891
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/22/2019
• Event Location: Hospital
• Date Report to Manufacturer: 05/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1