MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOLIGHT; LIGHT SOURCE LED 2.2 80W LED

Model Number	5164001
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Burn(s) (1757); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/07/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the nurse burned her hand while handling the light cable outside of the 2.2 light source during use.The operation was completed without harm to patient and without delay.

• Brand Name: ENDOLIGHT
• Common Device Name: LIGHT SOURCE LED 2.2 80W LED
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany 75438 ; GM 75438
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• Manufacturer Contact: valentin felsing ; pforzheimer strasse 32; knittlingen, germany 75438 ; GM 75438
• MDR Report Key: 22677436
• Report Number: 9611102-2025-00039
• Device Sequence Number: 21223881
• Product Code: NTN
• UDI-Device Identifier: 04055207055212
• UDI-Public: 04055207055212
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K121724
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 07/31/2025

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
• Device Model Number: 5164001
• Device Catalogue Number: 5164001
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/16/2025
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/16/2025
• Initial Report FDA Received Date: 07/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/15/2024
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Sex: Unknown