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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID

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URETEROSCOPE; URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID Back to Search Results
Device Problems Biofilm coating in Device (1062); Problem with Sterilization (1596)
Patient Problems Bacterial Infection (1735); Urinary Tract Infection (2120)
Event Date 08/06/2020
Event Type  Injury  
Event Description
Hospital acquired infection; i was a patient (inpatient and outpatient) at (b)(6) hospital in (b)(6) from (b)(6) 2020 to present.Following a ureteroscopy on (b)(6), i was inoculated with a hospital-acquired infection serratia marcescens, likely from the ureteroscope.Following a subsequent surgery and removal of nephrostomy tube on (b)(6), i had a recurrence of s.Marcescens infection, likely due to disturbance of biofilm on nephrostomy tube.Full timeline is below.(b)(6) hospitalization for severe hydronephrosis due to upj obstruction due to crossing vessel (b)(6) nephrostomy tube was placed by interventional radiology (b)(6) no growth found in urine culture (b)(6) ureteroscopy (b)(6) foul odor, cloudy urine in nephrostomy bag.Urine culture positive for serratia marcescens.Begin ciprofloxacin prescribed by er.(b)(6) no growth found in urine culture (b)(6) no growth found in urine culture (b)(6) laparoscopic pyeloplasty and removal of nephrostomy tube (b)(6) cloudy urine.Urine positive for serratia marcescens nosocomial infection occurring 4 days after the (b)(6) ureteroscopy suggests inoculation during (b)(6) procedure, likely from ureteroscope.It is possible that the source of the infection was not the ureteroscope, but some other piece of equipment used in the procedure, or less likely, inadequate adherence to aseptic procedures by staff.Reusable ureteroscopes are used on multiple patients and have been demonstrated to be the source of urinary tract infections in patients undergoing ureteroscopy.Adequate cleaning of reusable ureteroscopes is known to be a challenge.Reusable ureteroscopes are cleaned and nominally sterilized by a variety of methods including peroxyacetic acid or glutaraldehyde soaks, or hydrogen peroxide gas.Failures of the hydrogen peroxide gas system have been reported and other systems are likely to result in similar failures of sterility.The source of serratia marcescens in ureteroscopes could be other patients (it is a well-documented nosocomial infection of the urinary tract or the hospital environment.Serratia marcescens is known to form biofilms on implants in patients.In patients with implants or undissolved sutures left behind from surgery, it is known to recur, sometimes for years, sometimes contributing to the death of the patient.My recurrent serratia marcescens infection, diagnosed on (b)(6), was likely to have come from the biofilm which had formed on my nephrostomy tube during my first infection inoculated (b)(6), diagnosed (b)(6).During my (b)(6) treatment with ciprofloxacin, the biofilm likely shielded some of the serratia marcescens from the antibiotic, making it impossible for my immune system to clear the infection from my body.The biofilm on the nephrostomy tube was likely disturbed when the tube was removed in my surgery on (b)(6), releasing serratia marcescens into my renal pelvis and newly reconstructed ureteropelvic junction, causing my september 6 infection, but not the original (b)(6) infection, which resulted from (b)(6) healthcare delivery on (b)(6).In my (b)(6) surgery, a stent was placed in my ureter.Having experienced a recurrent serratia marcescens infection diagnosed on (b)(6), i was concerned about yet another recurrent infection hiding in the biofilm which likely had formed on my stent during my recurrent infection with serratia marcescens.I consulted with a (b)(6) infectious diseases specialist on (b)(6) and he prescribed a 5-day course of ciprofloxacin to be taken at the time of the removal of my stent, to prevent a second recurrence due to disturbance of the biofilm on my stent.The stent on (b)(6).I discussed my recurrent infection and the prescription of ciprofloxacin with the urologist at this time.I took the ciprofloxacin as prescribed and currently have had no further uti symptoms.Reusable ureteroscopes at (b)(6) should be investigated as potential sources of infection.Identification performed by mass spectrometry( maldi-tof).Fda safety report id# (b)(4).
 
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Brand Name
URETEROSCOPE
Type of Device
URETEROSCOPE AND ACCESSORIES, FLEXIBLE/RIGID
MDR Report Key11629045
MDR Text Key244627592
Report NumberMW5100615
Device Sequence Number1
Product Code FGB
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Patient
Type of Report Initial
Report Date 04/02/2021
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? Yes
Device Operator Health Professional
Was Device Available for Evaluation? No
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/06/2021
Was Device Evaluated by Manufacturer? No Information
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other; Required Intervention;
Patient Age50 YR
Patient Weight66
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