MAUDE Adverse Event Report: RICHARD WOLF GMBH ENDOLIGHT; LIGHT SOURCE LED GREEN

Model Number	5165002
Medical Device Problem Code	Electrical /Electronic Property Problem (1198)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/01/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility has reported an issue regarding a light source led green, part no.5165002, and serial no.(b)(4)."intraoperatively switch laparoscopy camera to icg light.This causes technical difficulties.The icg light source does not work.Despite numerous attempts to eliminate these technical difficulties, including calls to the representative of wolf-corporation, it is not possible to correct the defect." the user facility has stated that the patient was doing well although, scheduled procedure was not completed.Additional unscheduled medical treatment needs to be taken to complete the planned procedure.
Additional Manufacturer Narrative
The reported device is not returned to richard wolf gmbh for investigation, yet.
Additional Manufacturer Narrative
The reported device light source led green 5165002 was investigated in accordance with test instructions.The reported issue could not be confirmed.Also an endurance test was performed together with all required equipment's for icg procedure, but no failure of reported device was present.The user has only returned the light source led green 5165002, so the root cause of the reported issue cannot be determined.The light source led green 5165002, serial # (b)(6) was manufactured on 13/jun/2022.No issue was identified during production.No further complaints with the similar device failure were received regarding the device light source led green 5165002.The ifu ga-a344/en/us/v1.0/2022-06/contains the list of the required equipment for icg procedure in section 2.5 combinations and 2.6 product combinations for nir-fluorescence diagnosis.Also, the user is advised to check the entire system prior use in section 4 checks.Furthermore, there are operating instructions regarding the icg procedure in section 5.3 operation of system green.The subject issue of not usable device is present in the risk management file e4-3: led light sources, document version: r01.The overall probability of occurrence for this issue remains at previously defined levels and overall risk of the device remains in the acceptable category.

• Brand Name: ENDOLIGHT
• Common Device Name: LIGHT SOURCE LED GREEN
• Manufacturer (Section D): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438 knittlingen, germany ; GM
• Manufacturer (Section G): RICHARD WOLF GMBH; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• Manufacturer Contact: oliver ehrlich ; pforzheimer strasse 32; d-75438, knittlingen, germany ; GM
• MDR Report Key: 16470476
• Report Number: 9611102-2023-00013
• Device Sequence Number: 5182669
• Product Code: NTN
• UDI-Device Identifier: 04055207065631
• UDI-Public: 04055207065631
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/27/2023

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: 5165002
• Device Catalogue Number: 5165002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/21/2023
• Supplement Date Received by Manufacturer: 04/21/2023
• Initial Report FDA Received Date: 03/02/2023
• Supplement Report FDA Received Date: 04/28/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/13/2022
• 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
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown