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

Model Number CYF-5R

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

Patient Problem Sepsis (2067)

Event Date 08/19/2019

Event Type  Injury  

Manufacturer Narrative

The scope was not returned to the service center for evaluation.The cause of the reported event cannot be determined at this time.An investigation to obtain more detailed information regarding the reported events is ongoing.

Event Description

The service center was informed that during a reprocessing and infection control in-service conducted with an olympus endoscopy support specialist (ess), the user facility reported that two septic patients were admitted after undergoing procedures.The user facility reported that the scope is washed in water, its channel is also brushed in water, the scope is then placed in disinfectant, sterilized with glutaraldehyde for 30 minute, the scope is brushed again in high level disinfectant and finally rinsed off in water.The patients course of treatment is unknown.In addition, during the visit the ess observed the user facility¿s reprocessing methods and noted the following deviations: the facility was not correctly pre-cleaning, leak testing, using detergent, manual cleaning or storing the scope.The ess reported that facility does not currently have a leak tester, or storage cabinet.The ess covered infection control information referenced in the manufacturer¿s user manual and reprocessing manual.This report is for 1 of 2 patients.

• 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: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 9069991
• MDR Text Key: 158643519
• Report Number: 8010047-2019-03277
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411182
• UDI-Public: 04953170411182
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• 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: 09/16/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5R
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/19/2019
• 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): Hospitalization; Life Threatening