MAUDE Adverse Event Report: STORZ MEDICAL AG STORZ RIGID URETEROSCOPE 6 DEGREE

Model Number 27002L

Device Problem Insufficient Information (3190)

Patient Problems Laceration(s) (1946); Tissue Damage (2104)

Event Date 07/17/2015

Event Type  Injury  

Event Description

Patient undergoing cystoscope, ureteroscopy, holmium laser lithotripsy.At the end of procedure, the scope was being removed.Upon removal of the scope by the surgeon, there was 17 cm of the right ureter on the scope.There was an intussusception of the ureter with complete avulsion.Patient was taken to cath lab for insertion of a right nephrostomy tube.

• Brand Name: STORZ RIGID URETEROSCOPE 6 DEGREE
• Type of Device: URETEROSCOPE
• Manufacturer (Section D): STORZ MEDICAL AG; lohstampfestrasse 8; tagerwilen 8274 ; SZ 8274
• MDR Report Key: 4994715
• MDR Text Key: 22883484
• Report Number: 4994715
• Device Sequence Number: 1
• Product Code: FGB
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• 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
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 27002L
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 07/31/2015
• Distributor Facility Aware Date: 07/17/2015
• Event Location: Hospital
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/03/2015
• 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
• Treatment: NONE
• Patient Outcome(s): Required Intervention; Disability
• Patient Age: 44 YR
• Patient Weight: 113