MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION CYSTO-NEPHRO VIDEOSCOPE; CYSTOSCOPE

Model Number CYF-V2

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 10/05/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.As part of our investigation into this report, olympus dispatched an endoscopy support specialist (ess) to the user facility to observe their reprocessing techniques.The date for this visit has not yet been set.The exact cause of the patient's outcome could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.The instruction for use states, "failure to properly clean and high-level disinfect or sterilize endoscopic equipment after each procedure may compromise patient safety.To minimize the risk of transmitting diseases from one patient to another, after each procedure that endoscope and its ancillary equipment must undergo thorough manual cleaning followed by high-level disinfection or sterilization as described in chapter 7, cleaning, disinfection, and sterilization procedures.Reprocess not only the external surface of the endoscope but also all channels." please cross reference mfr numbers; 2951238-2015-00504, 2951238-2015-00505, and 2951238-2015-00507.

Event Description

Olympus was informed that four patients developed pseudomonas infection after undergoing a cystoscopy procedure.The user facility reported that two to three days after the procedure, the four patients returned to the facility with the same symptom of burning during urination (urinary tract infection).Urine samples were collected from all four patients, and all tested positive for pseudomonas.Antibiotics were immediately administered to the four patients.All four patients tested negative post antibiotics and are doing well.The user facility reported that the scope was cleaned with revitalox resert.No further information was provided.This is three of four reports.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho,; hachioji-shi, tokyo,, 192-8 507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood avenue; san jose, CA 95131 ; 4089355002
• MDR Report Key: 5182097
• MDR Text Key: 29403362
• Report Number: 2951238-2015-00506
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Assistant
• Type of Report: Initial
• Report Date: 10/27/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Device Catalogue Number: CYF-V2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/05/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Required Intervention