MAUDE Adverse Event Report: KARL STORZ ENDOVISION VIDEO-URETERO-RENOSCOPE FLEX XC; VIDEO URETEROSCOPE

Model Number 11278VSUEK

Device Problem Insufficient Information (3190)

Patient Problem Insufficient Information (4580)

Event Date 11/29/2021

Event Type  malfunction  

Manufacturer Narrative

The receipt and evaluation of affected device is pending.

Event Description

Per the customer, the video ureteroscope's bending rubber split apart during a case, and the whole scope became stuck inside of patient.The surgeon used a laser to incise mucosa on the inside of patient's ureter in order to remove the video ureteroscope, and placed a stent, which will be left in for two weeks.

• Brand Name: VIDEO-URETERO-RENOSCOPE FLEX XC
• Type of Device: VIDEO URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 13803 n. promenade blvd.; stafford, TX 77477
• MDR Report Key: 12968521
• MDR Text Key: 283767584
• Report Number: 1221826-2021-00087
• Device Sequence Number: 1
• Product Code: FGB
• UDI-Device Identifier: 04048551417003
• UDI-Public: 4048551417003
• 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: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 11278VSUEK
• Device Catalogue Number: 11278VSUEK
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/01/2021
• Initial Date FDA Received: 12/09/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention
• Patient Age: 56 YR
• Patient Sex: Male