MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. 16 FR. FLEXIBLE VIDEO CYSTOSCOPE

Model Number 11272VNUK

Device Problems Microbial Contamination of Device (2303); Contamination /Decontamination Problem (2895)

Patient Problems Unspecified Infection (1930); Patient Problem/Medical Problem (2688)

Event Type  malfunction  

Manufacturer Narrative

We received the scope from the customer and are working on a microbiological assessment on recovered organisms.When the assessment result is ready we will file a supplement report, which we expect will be early june.

Event Description

Allegedly, the flexible cystoscope was used in 4 cases and the clinic reports 2 patients contracted an infection.

Manufacturer Narrative

Received testing results and no link could be made to the patient infections and any persistent microbial growth (i.E.Biofilm) could not be identified.It was found the shaft is crushed 48mm from shaft adapter and the vertebrae system is crushed 30mm from distal tip.Unable to confirm customer's complaint.Ich was pending the updates.

• Brand Name: 16 FR. FLEXIBLE VIDEO CYSTOSCOPE
• Type of Device: FLEXIBLE VIDEO CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton, ma
• MDR Report Key: 10077291
• MDR Text Key: 191663603
• Report Number: 1221826-2020-00059
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• PMA/PMN Number: K062918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 04/24/2020

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: Health Professional
• Device Model Number: 11272VNUK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/28/2020
• Initial Date Manufacturer Received: 04/24/2020
• Initial Date FDA Received: 05/20/2020
• Supplement Dates Manufacturer Received: 04/24/2020
• Supplement Dates FDA Received: 07/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other