MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORPORATION OES CYSTONEPHROFIBERSCOPE; CYSTOFIBERSCOPE

Model Number CYF-5

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

Patient Problem Bacterial Infection (1735)

Event Date 06/10/2015

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report is not available for evaluation.As part of the investigation, an olympus endoscopy support specialist (ess) was dispatched to the facility to observe reprocessing practices and to provide training or in-service.The ess found the facility uses a non-olympus automated endoscope reprocessor and understood that the guidelines for their unit would have to be provided by the manufacturer.Upon request by the facility, the ess completed an in-service and provided training to the facility's staff on the appropriate cleaning and reprocessing method.The exact cause of the reported event could not be conclusively determined at this time.Please cross reference mfr.Report numbers: 2951238-2016-00069, 2951238-2016-00080, 2951238-2016-00082, and 2951238-2016-00083 to account for the five patients involved in this event.

Event Description

Olympus was informed that five patients developed bacterial infections after undergoing cystoscopy procedures.The dates of the procedures occurred between (b)(6) 2015.Four out of five patients' urine culture tested positive for pseudomonas.The type of bacteria recovered from the fifth's patient urine culture is unknown.The five patients have since recovered.The facility reported there has been no further recurrence of bacterial infection events and isolated the occurrence to a loaner cystoscope that was used in these five cystoscopies.Patient 3 of 5 tested positive for pseudomonas aeruginosa.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTOFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo, 192-8 507; JA 192-8507
• Manufacturer Contact: donny shapiro ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355161
• MDR Report Key: 5494087
• MDR Text Key: 40113895
• Report Number: 2951238-2016-00081
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K993041
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 03/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Device Catalogue Number: CYF-5
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/09/2016
• 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
• Patient Outcome(s): Other