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 07/10/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report was returned to olympus for evaluation and is pending investigation.As part of our investigation into this report, olympus dispatched an endoscopy support specialist (ess) to the user facility to observe their reprocessing practices.At this time the user facility has not yet scheduled a date for the in-service.The exact cause of the patient's outcome could not be conclusively determined at this time.If additional and significant information becomes available at a later time these reports will be supplemented.Cross reference: 2951238-2015-00383, 2951238-2015-00384 and 2951238-2015-00385.

Event Description

Olympus was informed that four patients developed infections after undergoing a diagnostic cystoscopy procedure.The user facility reported that the scope was cleaned with an enzymatic cleaner and a high level disinfectant after every procedure.No further information was provided olympus followed up with the user facility to obtain additional information regarding the reported event via telephone and in writing but with no result.This is four of four reports.

Manufacturer Narrative

This supplemental report is to provide the laboratory results, and device evaluation results.Based on the microbiological testing conducted at an off-site laboratory, the scope tested positive for micrococcus luteus and bacillus circulans.The micrococcus luteus are not considered clinically significant and is often an environmental organism.The bacillus circulans is a common soil saprophyte that causes food poisoning and occasionally causes conjunctivitis.The organisms were recovered from the instrument and suction channel.The scope was eto sterilized by an off-site laboratory before returning to olympus.A boroscope was used to examine the internal instrument channels of the scope and found no foreign material.Additionally, there were also no signs of foreign materials found in the bending section cover, bending section cover glue, insertion tube, light guide tube and distal end cover of the device.The device passed a leak test.The cause of the patient's outcome could not be conclusively determined as there were no abnormalities found with the scope.However insufficient reprocessing cannot be ruled out.In addition, an endoscopy support specialist (ess) performed an in-service training and observed the reprocessing practices at the user facility on september 10, 2015.The ess found that the scope was not leak tested prior to manual cleaning and enzymatic is not used for manual cleaning.The customer stated they brushed the scope and then it is rinsed.The scope is not flushed with the use of a 30cc syringe during manual cleaning and high level disinfection.The high level disinfection is not being tested for efficacy each time a scope is high level disinfected.The scope is also not being flushed with alcohol prior to storage.The ess provided an in-service training to the user facility in accordance with the reprocessing manual and on-track form.The ess advised the customer to disassemble the biopsy valve for manual cleaning, high level disinfection and use detergent solution during the manual cleaning process.Additionally, the ess recommended that the site purchase a leak tester.Furthermore, the customer was advised to contact olympus regarding the high level disinfectant used and to acquire test strips as this would improve the sterility of the device.The instruction manual warns users: "medical literature reports incidents of cross-contamination resulting from improper cleaning, disinfection, and sterilization.It is strongly recommended that all individuals engaged in reprocessing closely observe all instructions given in this manual and the manual of all ancillary equipment, and have a thorough understanding of the following items: health and safety policies and procedures of your hospital.Individual cleaning, disinfection, and sterilization protocols.Structure and handling of endoscopic equipment.Safe and effective handling of pertinent chemicals.".

• 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: 5033244
• MDR Text Key: 24171094
• Report Number: 2951238-2015-00386
• 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: Physician
• Report Date: 10/09/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/26/2015
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-V2
• Device Catalogue Number: CYF-V2
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/17/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/07/2015
• 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