MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP OLYMPUS CYSTOFIBERSCOPE

Model Number CYF-5R

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

Patient Problem Bacterial Infection (1735)

Event Date 08/19/2014

Event Type  Injury  

Event Description

Olympus was informed that two pts tested positive for pseudomonas aeruginosa after undergoing a cystoscopy procedure.The user facility reported that urine cultures were performed on both pts.The pts were treated with antibiotics and their current condition is unk at this time as no follow up visits have occurred.It was also noted that the aldahol had not been replaced on time in one of the user facility's cleaning rooms according to the logs.An endoscopy service specialist (ess) was dispatched and reprocessing in-service training were performed.It was observed by the ess that the user facility was not performing leak testing on their scopes as recommended per olympus protocol.The device has been removed from service.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for eval.The exact cause of the pt's outcome could not be conclusively determined at this time.If add'l info becomes available at a later time, this report will be supplemented.

• Brand Name: OLYMPUS CYSTOFIBERSCOPE
• Type of Device: CYSTOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORP; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4106178
• MDR Text Key: 21805587
• Report Number: 2951238-2014-00424
• Device Sequence Number: 1
• Product Code: FBO
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 08/29/2014

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: Health Professional
• Device Model Number: CYF-5R
• Device Catalogue Number: CYF-5R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/29/2014
• Initial Date FDA Received: 09/12/2014
• 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): Other
• Patient Age: 81 YR