MAUDE Adverse Event Report: KARL STORZ; THIN PEDI SYSTEM

Model Number 27033

Device Problems Fluid/Blood Leak (1250); Inflation Problem (1310)

Patient Problem Scar Excision (2358)

Event Date 06/11/2019

Event Type  Injury  

Event Description

The nipple that controls fluid from exiting the scope was missing and the surgeon could not maintain the pressure.Surgeon had to insert and remove the scope several times to troubleshoot the problem.During this removal and insertion, a urethral tear was created.

• Brand Name: KARL STORZ
• Type of Device: THIN PEDI SYSTEM
• MDR Report Key: 8770942
• MDR Text Key: 150549967
• Report Number: 8770942
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/11/2019,06/28/2019

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: No Information
• Device Model Number: 27033
• Device Catalogue Number: 17114-000
• Device Lot Number: STZPDICYS-000
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 06/24/2019
• Distributor Facility Aware Date: 06/11/2019
• Event Location: Hospital
• Date Report to Manufacturer: 06/28/2019
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/01/2019
• Was Device Evaluated by Manufacturer?: No Information
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 25 YR