MAUDE Adverse Event Report: KARL STORZ ENDOSCOPY-AMERICA, INC. FLEXIBLE CYSTOSCOPE; CYSTOURETHROSCOPE

Model Number 11272VHUK-TL

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/26/2024

Event Type  malfunction  

Event Description

Karl storz flexible cystoscope 11272vhuk-tl present green plastic substance during reprocessing from lumen after being brushed and flushed.Confirmed reprocessing steps and that appropriate brush was used with karl storz.During initial lease swap 6 of the 16 scopes swapped presented with this green plastic component and were not put into service and swapped immediately.Karl storz determined that this issue was a manufacturing error.Manufacturing dates occurred from october 4th 2023 to december 5th 2023.Initial 16 scopes were manufactured november 7th 2023.The 6 scopes that presented initially with the green plastic were swapped out with 6 scopes that were manufactured on january 8th 2024 and january 5th 2024 which is outside of the suspected time frame of the manufacturer error.The 10 scopes that were not swapped out initially had no issues noted until 1-26-2024.After this green plastic presented on 1-26- 2024 on one scope all 16 scopes were sequestered until further investigating was done with karl storz.Reference reports: mw5151530, mw5151531, mw5151532, mw5151533, mw5151534, mw5151535, mw5151536, mw5151537, mw5151538, mw5151539, mw5151540, mw5151542, mw5151543, mw5151544, mw5151545.

• Brand Name: FLEXIBLE CYSTOSCOPE
• Type of Device: CYSTOURETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOSCOPY-AMERICA, INC.
• MDR Report Key: 18702692
• MDR Text Key: 335528911
• Report Number: MW5151541
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/08/2024

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: 11272VHUK-TL
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/13/2024
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1