MAUDE Adverse Event Report: KARL STORZ SE & CO. KG KARL STORZ FLEX -X2; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 11278AU1

Device Problem Component Missing (2306)

Patient Problem Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)

Event Date 02/24/2021

Event Type  malfunction  

Event Description

Rubber sheath over the distal end of the flexible ureteroscope was missing following a ureteroscopy for stent placement.Patient will be coming back in a couple of weeks for a second stone manipulation as the doctor did not get enough stone.Patient disclosed.Fda safety report id# (b)(4).

• Brand Name: KARL STORZ FLEX -X2
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): KARL STORZ SE & CO. KG
• MDR Report Key: 11421761
• MDR Text Key: 238403444
• Report Number: MW5099801
• Device Sequence Number: 1
• Product Code: FGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 03/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11278AU1
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 53 YR
• Patient Weight: 52