MAUDE Adverse Event Report: KARL STORZ ENDOVISION FLEXIBLE VIDEO CYSTOSCOPE

Model Number 11272VNU

Device Problems Contamination /Decontamination Problem (2895); Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Bacterial Infection (1735)

Event Date 07/12/2016

Event Type  Injury  

Manufacturer Narrative

The product evaluation concluded the following: shaft has over bends next to strain relief.Monocoil to vertebrae welding break.Multiple scrape marks inside channel with bump, no leak found.Voids around spread lens and ccd window with debris.Chipped spread lens.Debris at handle housing and at hand grip surface.Kinked umbilical cord.Broken light fibers inside handle housing and at vertebrae system.Debris at angle cover surface.The evidence produced from this investigation suggests that user error can be linked to the physical state of the instrument.The documented scope damage could be a contributory factor towards patient infection.In order to perform a microbiological assessment of the video cysto urethroscope (11272vnu, s/n (b)(4)), it was sampled by flushing all channels and the outer surfaces with process water.The samples were submitted to nelson laboratories to specifically determine if p.Aeruginosa was present.The final report from nelson laboratories confirmed that the organism in question (p.Aeruginosa) was not present in the samples analyzed.

Event Description

Allegedly, doctor performed a bladder tumor surgery and a diagnostic bladder cancer procedure.Post procedure, the patient exhibited symptoms.A urine culture was taken and it confirmed pseudomonas aeruginosa infection.The patient was prescribed mitomycin and is responding well to the treatment.There were 3 patients infected; this report is for patient #3.

• Brand Name: FLEXIBLE VIDEO CYSTOSCOPE
• Type of Device: FLEXIBLE VIDEO CYSTOSCOPE
• Manufacturer (Section D): KARL STORZ ENDOVISION; 91 carpenter hill road; charlton MA 01507
• Manufacturer (Section G): KARL STORZ GMBH & CO. KG TUTTLINGEN, GERMANY; mittlestrasse 8,; 78503; tuttlingen, germany, ; GM
• Manufacturer Contact: susie chen ; 2151 e. grand avenue; el segundo, CA 90245-5017 ; 4242188201
• MDR Report Key: 5912720
• MDR Text Key: 53446153
• Report Number: 1221826-2016-00129
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K062918
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/29/2016

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: Physician
• Device Model Number: 11272VNU
• Device Catalogue Number: 11272VNU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/29/2016
• Initial Date FDA Received: 08/29/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2016
• 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 Age: 63 YR
• Patient Weight: 88