MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE; FLEXIBLE AND RIGID URETEROTOME SYSTEM

Model Number A4674A

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/22/2024

Event Type  malfunction  

Manufacturer Narrative

To date, the device has not been returned to olympus for evaluation.The investigation is ongoing and follow up with the user facility is currently being performed.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.

Event Description

It was reported, that the telescope had the connecting tube connector missing.The issue was found during preparation for use.There were no reports of patient harm.

Manufacturer Narrative

This report is being supplemented to provide additional information including the device evaluation results and the legal manufacturer's final investigation.Additionally, (d8) was this device serviced by a third party? no was selected, (d9) returned to manufacturer date was added, and (h3) device evaluated by manufacturer was updated to yes.The device was returned to olympus for inspection, and the reported issue was confirmed.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 19 years since the subject device was manufactured.Based on the results of the investigation, root cause of the missing connector tube connector is consistent with improper handling or excessive mechanical force.However, specific root cause could not be determined.Olympus will continue to monitor field performance for this device.

• Brand Name: TELESCOPE, 3 MM, 30°, WIDEANGLE, AUTOCLAVABLE
• Type of Device: FLEXIBLE AND RIGID URETEROTOME SYSTEM
• 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: 18672733
• MDR Text Key: 336075385
• Report Number: 9610773-2024-00402
• Device Sequence Number: 1
• Product Code: GCP
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K904939
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 02/23/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: A4674A
• Device Lot Number: 412527
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2004
• 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