MAUDE Adverse Event Report: OLYMPUS WINTER & IBE GMBH URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A; RIGID URETEROSCOPE

Model Number WA29042A

Device Problem Material Integrity Problem (2978)

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

Event Date 03/20/2024

Event Type  malfunction  

Event Description

It was reported, the rigid ureteroscope's distal end was damaged.The issue occurred during preparation for use for an unspecified diagnostic procedure.There were no reports of patient harm.

Manufacturer Narrative

The device evaluation is ongoing.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: URETEROSCOPE, 8,6/9,8 FR. X 430 MM, 7°, 6,4 FR. CHANNEL, WITH WA00396A
• Type of Device: RIGID 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, hamburg 22045 ; GM 22045
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 19011420
• MDR Text Key: 339153241
• Report Number: 9610773-2024-00916
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04042761062503
• UDI-Public: 04042761062503
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K951855
• 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
• Report Date: 04/01/2024

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
• Device Operator: Health Professional
• Device Model Number: WA29042A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2024
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 03/20/2024
• Initial Date FDA Received: 04/01/2024
• Was Device Evaluated by Manufacturer?: No
• 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