MAUDE Adverse Event Report: KARL STORZ KARL STORZ, 7.5 FR FLEXIBLE URETEROSCOPE

Model Number 11278AU1

Device Problem Microbial Contamination of Device (2303)

Patient Problems Fever (1858); Septic Shock (2068)

Event Date 11/01/2016

Event Type  Injury  

Event Description

Pt underwent urological procedure with 7.5 fr flex x2 ureteroscope on (b)(6) and was discharged home in stable condition.Returns to ed on (b)(6) 2016 with fever, and is transferred to icu in septic shock.Pt grows e.Faecalis from urine culture.Second pt undergoes similar urological procedure on (b)(6) 2016 with the same scope and becomes ill shortly after requiring transferred icu.Blood cultures grow e.Faecalis.Scope is pulled from service and sampled, culture results are negative with no growth.No known colonization of e.Faecalis in either pt.

• Brand Name: KARL STORZ, 7.5 FR FLEXIBLE URETEROSCOPE
• Type of Device: 7.5 FR FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): KARL STORZ; el segundo CA
• MDR Report Key: 6099529
• MDR Text Key: 59789115
• Report Number: MW5066011
• Device Sequence Number: 1
• Product Code: FGB
• 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: 11/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11278AU1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/10/2016
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 13 YR