MAUDE Adverse Event Report: KARL STORZ ENDOVISION, INC. FIBERSCOPE, CYSTO-URETHRO, REVERSE; FLEXIBLE CYSTOSCOPE

Model Number 11272CK2

Device Problems Material Puncture/Hole (1504); Material Perforation (2205); Material Integrity Problem (2978); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The item has returned.Several unsuccessful attempts have been made to gather further information from the clinic.Once information is received, it will determine if a microbiological assessment needs to be performed.A supplemental report will be submitted upon completion of evaluation.

Event Description

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

Manufacturer Narrative

Testing performed by global rsb showed no viable signs of microorganisms nor bioburden in extract samples from the working channel for item 11272ck2 / sn (b)(6): 1.Initial extraction of the working channel upon device was received.2.Reprocessing the endoscope manually according to our ifu (without sterilization).3.2nd extraction of working channel.The results from the laboratory show no viable microorganism in both extracts: no contamination / bioburden detectable in the channel.Item was then returned to manufacture on 10/13/2021 further evaluation found broken image fibers, which is the reason for the low light output; 30.4mw, debris on vertebrae, external puncture in the angle cover at 10mm from distal end, leaking and deflection failed; 210° up/115° down.

• Brand Name: FIBERSCOPE, CYSTO-URETHRO, REVERSE
• Type of Device: FLEXIBLE CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ ENDOVISION, INC.; 91 carpenter hill road; charlton MA 01507
• Manufacturer Contact: anja fair ; 2151 east grand avenue; el segundo, CA 90245-5017 ; 8004210837
• MDR Report Key: 12108250
• MDR Text Key: 259983623
• Report Number: 1221826-2021-00054
• 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: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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: 11272CK2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/04/2021
• Initial Date FDA Received: 07/02/2021
• Supplement Dates Manufacturer Received: 06/04/2021
• Supplement Dates FDA Received: 11/10/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 10/30/2019
• 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