MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM

Model Number 11272CUK1

Device Problem Contamination /Decontamination Problem (2895)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Event Description

Two flexible cystoscopes were used in cases back in (b)(6) 2021 and possibly early (b)(6)2021, and the facility believes they may be passing infections to the patients.Customer believes that 5 to 7 patients contracted an infection but was unable to verify exact quantity of patient infections.Customer returned two different model cystoscopes that they believed were involved in the cases, model #'s 11272cuk1 and 11272ck2, and we previously submitted two reports, one for each model (report #1221826-2021-00051 and report #1221826-2021-00054).This report is for the case #3 of the of seven cases.

Manufacturer Narrative

The evaluation found an overbend in the proximal shaft; the channel wall was lifted, no leak; debris was found on the vertebrae; and broken image and light fibers.Our field service specialist performed an in-service and found several areas for process improvements within the facility that will help them with infection control in the future.

• Brand Name: FLEXIBLE CYSTOSCOPE, CHNL:7FR, 15FRX37CM
• Type of Device: FLEXIBLE CYSTOSCOPE
• 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: anja fair ; 2151 e grand ave; el segundo, CA 90245-5017 ; 4242188738
• MDR Report Key: 14643663
• MDR Text Key: 293629525
• Report Number: 1221826-2022-00084
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K945185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 06/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11272CUK1
• Device Catalogue Number: 11272CUK1
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/20/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/04/2019
• 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; Required Intervention