MAUDE Adverse Event Report: STORZ ENDOSKOP PRODUKTIONS GMBH STORZ 11278AU1 (FLEX-X) SCOPE URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

Model Number 11278AU1

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 01/07/2022

Event Type  malfunction  

Event Description

During ureteroscopy doctor visualized foreign material/object in pt's right ureter.Object appears blue in color, was retrieved via basket and observed by staff.It was determined to be a small portion of the flexible ureteroscope that was in use, scope was passed off the field and incident reported to product rep.Damaged scope reported to spd, passed off the field and new flexible ureteroscope was used for duration of the case.No detectable harm to the pt.Fda safety report id # (b)(4).

• Brand Name: STORZ 11278AU1 (FLEX-X) SCOPE URETEROSCOPE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
• Manufacturer (Section D): STORZ ENDOSKOP PRODUKTIONS GMBH
• MDR Report Key: 13251919
• MDR Text Key: 283947025
• Report Number: MW5106633
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): Y
• 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: 01/10/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/12/2022
• 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
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White