MAUDE Adverse Event Report: KARL STORZ ENDOVISION CYSTO-URETHRO-FIBERSCOPE; CYSTO-URETHROSCOPE

Model Number 11272C1

Device Problems Leak/Splash (1354); Material Integrity Problem (2978); Insufficient Information (3190)

Patient Problems Urinary Tract Infection (2120); Insufficient Information (4580)

Event Date 02/11/2021

Event Type  malfunction  

Manufacturer Narrative

Manufacturer's preliminary comments: the initial analysis of the causes of this incident: device was not yet returned for investigation; therefore, final root cause could not be identified.The pre-investigation showed that the endoscope (b)(4) was delivered to the customer on 28.08.2019.Since this time, the endoscope has been used 455 times according to the customer.Since delivery, the endoscope has never been sent in for repair or inspection.The list of similar incident that have occurred in (b)(6) or in europe with this cystoscope reference over the last 3 years: there is no similar incident that has occurred in (b)(6) or in europe over the last 3 years.The specific recommendation mentioned in the manual of this device in order to avoid the orrcurrence of the type of incident: according to ifu, the following recommendations were stated: - inspect the fiberscope prior to each surgical procedure to ensure that it is functioning correctly and that it has been correctly cleaned, disinfected and (where applicable) sterilized.- the fiberscope is delivered unsterilized, and must therefore be cleaned, disinfected and (where applicable) sterilized prior to initial use and each subsequent reuse.- several chapters in the ifu contain instructions for cleaning, disinfection, sterilization and reprocessing.See chapters "14.Cleaning, disinfection, sterilization", "15.Preliminary cleaning", "16.Manual reprocessing", "17.Machine reprocessing", "18.Inspection after reprocessing", "19.Gas sterilization/ plasma sterilization", "20.Chemical sterilization".The number of cystoscopes installed in france with this model: total of (b)(4) cysto-urethro-fiberskops installed in (b)(6).

Event Description

As per a manufacturer incident report we received from the factory in (b)(4): from (b)(6) 2021, hospitalization of 3 patients for klebsialla pneumoniae ebsle urinary tract infection.This report is for hospitalization of patient #1 of 3.

Manufacturer Narrative

As per manufacturer's investigation results: the device in question was returned to the manufacturing site in germany on 02.06.2021 for investigation.Upon the evaluation it could be confirmed that the endoscope shows signs of wear, which have also led to leaks as stated in the related investigation report: the chemical attack and leakage under the kink protector is unlikely to be a possible cause of the infections.Since the kink protector has no patient contact, there is no critical consideration for this.No microorganisms migrate from the kink protection into the canal system.The root cause for corrosion is most likely, that the cleaning agents which were used for reprocessing, were too aggressive.The damage of the product is not caused by a production problem or material defect.In addition, we would like to call your attention to the description of reprocessing, as written in the ifu, chapter 14.However, according to ifu, the following recommendations were stated: inspect the fiberscope prior to each surgical procedure to ensure that it is functioning correctly and that it has been correctly cleaned, disinfected and (where applicable) sterilized.The fiberscope is delivered unsterilized, and must therefore be cleaned, disinfected and (where applicable) sterilized prior to initial use and each subsequent reuse.

• Brand Name: CYSTO-URETHRO-FIBERSCOPE
• Type of Device: CYSTO-URETHROSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• MDR Report Key: 11744779
• MDR Text Key: 280545558
• Report Number: 1221826-2021-00039
• Device Sequence Number: 1
• Product Code: FBO
• UDI-Device Identifier: 04048551226100
• UDI-Public: 4048551226100
• Combination Product (y/n): N
• PMA/PMN Number: K945185
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 04/07/2021

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: 11272C1
• Device Catalogue Number: 11272C1
• Was Device Available for Evaluation?: Yes
• Initial Date Manufacturer Received: 03/19/2021
• Initial Date FDA Received: 04/29/2021
• Supplement Dates Manufacturer Received: 03/19/2021
• Supplement Dates FDA Received: 08/04/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization