MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH SEALING CAP, 0.7 MM, TRANSPARENT, 10 PIECES, STERILE, SINGLE USE; WA00387A

Model Number	WA00387A
Medical Device Problem Code	Failure to Disinfect (1175)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the sealing cap used during a therapeutic transurethral lithotripsy (tul) was expired.The procedure was completed using a similar device.There were no reports of patient harm.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.Additional information: h6, h11.The product was not returned for evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the article had expired, which was not noticed by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: SEALING CAP, 0.7 MM, TRANSPARENT, 10 PIECES, STERILE, SINGLE USE
• Common Device Name: WA00387A
• 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
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 20352768
• Report Number: 9610773-2024-02401
• Device Sequence Number: 12758259
• Product Code: GCP
• UDI-Device Identifier: 14042761062968
• UDI-Public: 14042761062968
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K955623
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/30/2025

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: WA00387A
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 06/27/2025
• Initial Report FDA Received Date: 10/02/2024
• Supplement Report FDA Received Date: 06/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: WA29040A RIGID URETEROSCOPE
• Patient Sex: Unknown