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

Model Number	20132-218
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/08/2025
Type of Reportable Event	Malfunction
Event or Problem Description
From staff: medical device malfunction, argon plasma coagulator tip came off, fiapc sonde m.Filter 2200c item ref# 20132-218, lot# 212660.The tip of the argon plasma coagulator off very easily while cleaning it.For reference, the tip of the coagulator is 1/4 the size of an average pin head.Said tip came off with its wiring while cleaning it in the middle of surgery.Tip is currently not included in the submitted device because the said part has tissue in it and was best to have it discarded.As soon as the tip was noticed to have come off, device was plugged out and quickly replaced with a new one.No harm was done due to said incident but may potentially put patient at risk if it happens again intraoperatively while doing said coagulation if it may happen again.

• Brand Name: ERBE
• Common Device Name: ELECTROSURGICAL, CUTTING COAGULATION ACCESSORIES
• Manufacturer (Section D): ERBE ELEKTROMEDIZIN GMBH; 2225 northwest pkwy.; marietta GA 30067
• MDR Report Key: 23082969
• Report Number: 23082969
• Device Sequence Number: 10064530
• Product Code: GEI
• UDI-Device Identifier: 04050147014022
• UDI-Public: (01)04050147014022
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/15/2025
• Report Date (Section F): 09/15/2025

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: 20132-218
• Device Catalogue Number: 20132-218
• Device Lot Number: 212660
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Device Age: 1 YR
• Event Location: Hospital
• Date Report to Manufacturer: 09/18/2025
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/18/2025
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 54 KG
• Date Report Sent to FDA: 09/15/2025