MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES; ENDOSCOPIC LIGHT SOURCE, BATTERY-POWERED

Model Number	WA91502A
Medical Device Problem Code	Power Problem (3010)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E2/e3: no information available for the occupation of the initial reporter or whether they are a healthcare professional.The investigation is ongoing.A supplemental report will be submitted when the investigation is completed or if additional information becomes available.
Event or Problem Description
It was reported the light source turned on, but did not stay on.A button had to be helf for the light to stay on.There were no reports of patient harm.
Event or Problem Description
Customer new information received: the issue was found during a light source diagnostic procedure.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the results of the legal manufacturer's final investigation.The device was returned to olympus for evaluation and the customer's allegation was confirmed: the light is unable to stay on unless the power switch is held.Based on the results of the investigation, the most probable cause of the complaint is cause traced to component failure, which is expected or random component failure without any design or manufacturing issue.A device history record-dhr review was conducted, and no issues were identified.Olympus will continue to monitor field performance for this device.

• Brand Name: LIGHT SOURCE "ENDOLED", FOR FLEXIBLE ENDOSCOPES
• Common Device Name: ENDOSCOPIC LIGHT SOURCE, BATTERY-POWERED
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20037626
• Report Number: 9610773-2024-32236
• Device Sequence Number: 3024051
• Product Code: NTN
• UDI-Device Identifier: 04042761073592
• UDI-Public: 04042761073592
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K133311
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 09/19/2024

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: WA91502A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 08/12/2024
• Supplement Date Received by Manufacturer: 09/11/2024
• Initial Report FDA Received Date: 08/22/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/29/2024
• 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
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown