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

Model Number 11272CUK1

Device Problem Contamination /Decontamination Problem (2895)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The product was returned to the manufacturing site in (b)(4) and has been forwarded to the factory in (b)(6) for investigation.Should relevant additional information / the investigation results become available, supplemental medwatch report(s) will be submitted.

Event Description

It was reported that there was an issue with the product 11272cuk1 flexible cystoscope.According to the information received, the customer is complaining that this scope in particular is causing infections.They have traced back approximately 7 infections, and the common theme is the use of this scope.Additional information has been requested but not yet received as of the date of this report.This report is for the case #1 of the of seven cases.The adverse event is filed under internal complaint id (b)(4).

Manufacturer Narrative

The subject cysto-urethroscope was sent out for external lab testing.The microbiological status of the scope was evaluated before, and after, a manual cleaning and disinfection procedure: before manual cleaning and disinfection: pseudomonas was detected after processing: no pseudomonas; no microbiological objection (limit: >1cfu/ml) based on external lab testing, it has been concluded that the product is sterile when reprocessing is performed per ifu instruction.

• 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: 15543248
• MDR Text Key: 301177071
• Report Number: 1221826-2022-00270
• 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,Followup
• Report Date: 02/07/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/05/2022
• 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: 09/27/2022
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/11/2021
• 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