MAUDE Adverse Event Report: STORZ MEDICAL UNKNOWN; RIGID URETEROSCOPE 6 DEGREE

Model Number 27002L

Device Problem Extrusion (2934)

Patient Problem Tissue Damage (2104)

Event Date 07/17/2015

Event Type  Injury  

Event Description

Patient undergoing cystoscope, ureteroscopy, holmium laser lithotripsy for ureteral stone.At the end of procedure, upon removal of the scope by the surgeon, there was 17 cm of the right ureter on the end of the scope.There was an obvious intussusception of the ureter with complete avulsion.Patient was then taken to cath lab for insertion of a right nephrostomy tube.Patient will have to undergo reconstruction; future date is unknown,.

• Brand Name: UNKNOWN
• Type of Device: RIGID URETEROSCOPE 6 DEGREE
• Manufacturer (Section D): STORZ MEDICAL; lohstampfestrasse 8
• MDR Report Key: 4976432
• MDR Text Key: 22386794
• Report Number: MW5045160
• Device Sequence Number: 0
• Product Code: FGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Report Date: 07/31/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 27002L
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/31/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2014
• Is the Device Single Use?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 0
• Patient Outcome(s): Hospitalization; Disability
• Patient Age: 44 YR
• Patient Weight: 113