MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Patient Involvement (2645)

Event Date 11/17/2016

Event Type  malfunction  

Manufacturer Narrative

The device was not returned to olympus.The cause of the reported event cannot be determined at this time.An olympus endoscopy support specialist visited the site on november 17, 2016 and observed the user facility¿s reprocessing practices and provided an in-service training to the facility's staff.During the visit the ess noted the following deviations: the customer was not using enzymatic detergent during the bed side cleaning and manual cleaning.The staff was rinsing the scope once and not three times as recommended in the manufacture¿s reprocessing manual.The customer was provided a copy of the instruction manual and reprocessing manual for the cystoscope.

Event Description

Olympus was informed that the device cultured positive for ecoli after being reprocessed.It was reported that there was an e.Coli cross contamination in the urology lab at the user facility.It was reported that the facility¿s cyf-5 endoscopes were taken to a sister facility ((b)(6) medical center) central sterile department to be reprocess properly.It is unknown if the other scopes were cultured.The user facility reported that the scopes had not been utilized and there was no patient involvement.No further information was provided.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: connie tubera ; 2400 ringwood avenue; san jose, CA 95131 ; 408935-512
• MDR Report Key: 6178836
• MDR Text Key: 62541663
• Report Number: 2951238-2016-00947
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Device Catalogue Number: CYF-5
• Device Lot Number: N/A
• Other Device ID Number: 04953170292323
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/17/2016
• Initial Date FDA Received: 12/15/2016
• 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