MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY - AMERICA, INC. FIBEROPTIC LIGHTED URETER PROBE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE RIGID

Model Number 496U

Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506)

Patient Problem No Code Available (3191)

Event Date 10/16/2018

Event Type  malfunction  

Event Description

Probe used during surgery (b)(6) 2018.Blood / body fluid leakage into probe noted upon probe returned for reprocessing.Product malfunction and/or design flaw places pts at risk due to lighting failure during operative procedure.Infection risk increased due to pt's blood/body fluid and potential for carryover to subsequent pts.

• Brand Name: FIBEROPTIC LIGHTED URETER PROBE
• Type of Device: URETEROSCOPE AND ACCESSORIES, FLEXIBLE RIGID
• Manufacturer (Section D): KARL STORZ ENDOSCOPY - AMERICA, INC. ; 2151 e. grand ave; el segundo CA 90245
• MDR Report Key: 7999812
• MDR Text Key: 125105832
• Report Number: MW5080783
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/22/2018

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: Health Professional
• Device Model Number: 496U
• Device Lot Number: US13
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/23/2018
• 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
• Patient Outcome(s): Other