MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW; FLEXIBLE VIDEO CYSTOSCOPE, REUSABLE

Model Number 11272VH

Device Problems Device Reprocessing Problem (1091); Contamination /Decontamination Problem (2895)

Patient Problems Bacterial Infection (1735); Fever (1858); Inflammation (1932)

Event Date 04/21/2022

Event Type  Injury  

Manufacturer Narrative

The affected devices and further information have been requested for the investigation.For each infection case a separate complaint was recorded and each case will be reported separately.The 10 cases have the following karl storz reference numbers: (b)(4).This complaint #(b)(4) is representing one of the 8 cases that happened within the last 10 months.

Event Description

As per manufacturer incident report #(b)(4) received from the factory in germany: initially received information from the clinic: "i have been using flexible cystoscopy in my clinic since 1997.Annually i perform cystoscopy on the average in 300 cases.Our infection rate was very low previously; according to our records we had only 2 cases over the last 15 years.We recently upgraded our system with a brand new two digital flexible cystoscopes (11272vh) at last august 2021.Unfortunately, our infection rate significantly increased after this change.We had severe infection in 8 cases in 10 months although my staff is very experienced in this procedure.We have been working together for nearly 25 years.Seven of 8 patients had infection with klebsiella and 1 had e.Coli.Previously, we were using cidex opa, but we recently replaced it with sekusept aktiv.I designed a stainless-steel container and sterilized this container every two weeks.I routinely use prophylactic antibiotics and perform urine culture before cystoscopy.We took culture from different parts of our procedure room and no significant bacteria growth was observed.Despite our all efforts we had a significant rate of infection by using the new digital flexible cystoscopes." further information regarding case # (b)(4) received: no incident happened during cystoscopy procedure.After cystoscopy procedure, the patient went to the hospital with a complaint of high fever on the same day.As result of examination, the acute prostatic inflammation was detected.

Manufacturer Narrative

The corresponding manufacturer's complaint reference number for this case is (b)(4) the investigation of the concerned flexible video cystoscope was finished on (b)(6) 2022.The healthcare facility has provided information about the reprocessing methods (cleaning, disinfection, drying, storage) used for the device.Based on the received information the following was concluded: cleaning and disinfection are combined at the healthcare facility.There is a risk that the disinfectant loses its effectiveness.The reprocessing steps of cleaning and disinfection must always be performed in separate process steps in two separate basins/tubs (this requirement is mentioned in the ifu of the cleaning and disinfection agent "sekusept aktiv", used by the healthcare facility ).The drying of the channel is done with a syringe and subsequent storage is carried out lying down, which favors stagnation of residual fluid in the channel.In the corresponding ifu of the flexible video cystoscope, it is recommended that the surfaces and channels/lumina are dried completely with sterile compressed air.Furthermore, for decontaminated endoscopes only suspended storage is recommended in the ifu.It is therefore assessed, that the reprocessing is inadequate.After the flexible video cystoscope was returned for investigation, a swab of the endoscope rinsing fluid (both before and after a standard-compliant reprocessing process) was sent to an external laboratory.The external laboratory results showed that no microbiological abnormalities could be detected during the tests.This underlines the conclusion that the root cause of the reported infections was inadequate reprocessing.The investigation result will be communicated to the customer.

• Brand Name: FLEXIBLE VIDEO CYSTOSCOPE HD-VIEW
• Type of Device: FLEXIBLE VIDEO CYSTOSCOPE, REUSABLE
• 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: 14945760
• MDR Text Key: 295423548
• Report Number: 1221826-2022-00113
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K191357
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 09/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 11272VH
• Device Catalogue Number: 11272VH
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/01/2019
• 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
• Patient Sex: Male