MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEX X2 URETEROSCOPE; FLEXIBLE URETEROSCOPE

Model Number 11278AU1

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 11/01/2016

Event Type  Injury  

Manufacturer Narrative

Per the hospital, their cleaning records show the scope was cleaned and sterilized on (b)(6) before the 1st patient's procedure and after the 1st procedure before the 2nd patient's procedure on (b)(6) 2016.The scope was not used between these 2 procedures.The hospital's infection prevention team was working on the investigation and they told us they only cleaned/flushed the device after 2nd patient but did not sterilize it so they could send it to an outside lab to conduct the testing.They received the testing results back and they were negative for growth of e.Faecalis on this scope.Although the hospital indicated the scope has been returned to us, we could not identify a return after the event.We are working with hospital to determine the location of scope.No further infections have been reported.Hospital had it tested by an outside lab.

Event Description

Allegedly, the doctor performed a urological procedure on a patient.The procedure was completed in the morning and by late afternoon the patient was showing symptoms of fever; her blood culture confirmed presence of e.Faecalis infection.She was treated and released.

• Brand Name: FLEX X2 URETEROSCOPE
• Type of Device: FLEXIBLE URETEROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 6206298
• MDR Text Key: 63324888
• Report Number: 1221826-2016-00182
• Device Sequence Number: 1
• Product Code: FGB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K982905
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/29/2016

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: Physician
• Device Model Number: 11278AU1
• Device Catalogue Number: 11278AU1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/29/2016
• Initial Date FDA Received: 12/27/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 10 YR