MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE; OES ELITE URETEROSCOPES AND ACCESSORIES

Model Number WA2UR14A

Device Problem Detachment of Device or Device Component (2907)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/10/2023

Event Type  malfunction  

Manufacturer Narrative

D1: ureteroscope 7.3/10.4 fr.X 430 mm, 5°, angled ocular, 6.4 fr.Channel.The device was returned to olympus for evaluation, and the customer¿s allegation was confirmed.The evaluation found the following reportable issues: the stopcock closing nut was missing.No other issues were found.The investigation is ongoing and a supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

The customer reported to olympus that the ureteroscope 7.3/10.4 fr.X 430 mm, 5°, angled ocular, 6.4 fr.Channel had the stopcock come off after the first sterilization.The issue was found during the procedure.There were no reports of patient harm.

• Brand Name: URETEROSCOPE
• Type of Device: OES ELITE URETEROSCOPES AND ACCESSORIES
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18125763
• MDR Text Key: 328926245
• Report Number: 9610773-2023-03269
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761086363
• UDI-Public: 04042761086363
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K200369
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 11/13/2023

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
• Device Operator: Health Professional
• Device Model Number: WA2UR14A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2023
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/31/2023
• Initial Date FDA Received: 11/13/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/08/2023
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1