MAUDE Adverse Event Report: KARL STORZ SE & CO. KG VIDEO URETEROSCOPE 8.5 FR; FLEXIBLE VIDEO URETEROSCOPE

Model Number R11278VSUEK

Device Problems Display or Visual Feedback Problem (1184); Optical Obstruction (3002)

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

Event Date 09/02/2020

Event Type  malfunction  

Event Description

Per the sales rep who spoke with the doctor, during a ureteroscopy with scope in patient the image went black.The procedure was prolonged for 10 to 15 minutes.The doctor switched out the scope and completed the procedure with no patient harm.

Manufacturer Narrative

The product returned had significant damage which contributed to loss of image.Internal electronics were likely compromised from fluid invasion due to a channel leak caused from thermal damage.This is a result of use error.

• Brand Name: VIDEO URETEROSCOPE 8.5 FR
• Type of Device: FLEXIBLE VIDEO URETEROSCOPE
• Manufacturer (Section D): KARL STORZ SE & CO. KG; dr.-karl-storz-strasse 34; 78532; tuttlingen, gm
• Manufacturer (Section G): KARL STORZ SE & CO.KG; dr.-karl-storz -strasse 34; 78532; tuttlingen, gm
• Manufacturer Contact: anja fair ; 2151 e. grand avenue; el segundo, CA 90245 ; 4242188100
• MDR Report Key: 14336446
• MDR Text Key: 292595423
• Report Number: 9610617-2022-00069
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K141250
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/09/2022

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: R11278VSUEK
• Device Catalogue Number: R11278VSUEK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/08/2020
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/02/2020
• Initial Date FDA Received: 05/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2020
• 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
• Patient Outcome(s): Other