MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 7,5 FR. X 330 MM, 7°, 2 CHANNELS, STRAIGHT OCULAR ANGLE; AUTOCLAVABLE URETEROSCOPE

Model Number WA02946A

Device Problem Crack (1135)

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

Event Date 12/15/2022

Event Type  malfunction  

Manufacturer Narrative

The device was returned for evaluation and the customer¿s allegation was confirmed.It was noted that there were black spots on the image.The outer tube was bent and was missing the inner outer adapters.There was debris under the distal end cover glass and dents were noted on the frame.Debris was also seen under the optical system window and scratches were noted on the funnel.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 to olympus, that the autoclavable ureteroscope had a cracked lens.There were no reports of patient harm associated with the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.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 root cause could not be determined.It is likely the event occurred due to the use of excessive force by the customer.Olympus will continue to monitor field performance for this device.

• Brand Name: URETEROSCOPE, 7,5 FR. X 330 MM, 7°, 2 CHANNELS, STRAIGHT OCULAR ANGLE
• Type of Device: AUTOCLAVABLE URETEROSCOPE
• Manufacturer (Section D): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg, hamburg 22045 ; GM 22045
• Manufacturer (Section G): OLYMPUS WINTER & IBE GMBH; kuehnstrasse 61; hamburg
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16169843
• MDR Text Key: 307892855
• Report Number: 9610773-2023-00230
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761029940
• UDI-Public: 04042761029940
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K951855
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/28/2023

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: WA02946A
• Device Catalogue Number: WA02946A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/22/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 12/16/2022
• Initial Date FDA Received: 01/14/2023
• Supplement Dates Manufacturer Received: 04/04/2023
• Supplement Dates FDA Received: 04/28/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/15/2020
• 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