MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. VISERA CYSTO-NEPHRO VIDEOSCOPE

Model Number CYF-V2

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/21/2015

Event Type  malfunction  

Manufacturer Narrative

This device referenced in this report has not been returned to olympus keymed for evaluation.A leakage test was carried out and positive leak was confirmed from the biopsy channel.Further investigation found the leaking area to be located at the connection between the biopsy channel and the channel mount.Fluid ingress and severe corrosion were present internally within the control section.The biopsy channel was confirmed to be damaged and leaking and has resulted in fluid entry within the instrument control section.The fluid ingress has subsequently caused severe corrosion to the biopsy port and surrounding areas.Based on the above observations, the substance found to be leaking from the instrument channel is attributed to the fluid that has entered the instrument through the leak, has subsequently discolored through corrosion and mixing with internal lubricants, and then has leaked back out of the instrument.The manufacturing history was reviewed, with no irregularities related to this problem noted.The instrument was sold (b)(6) 2012 and has no repair history with olympus service.

Event Description

Olympus medical systems corp.(omsc) was informed that the subject device showed signs of leaking brown fluid in the storage cabinet after reprocessing.There was no patient harm reported.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 6425177
• MDR Report Key: 5122849
• MDR Text Key: 27617486
• Report Number: 8010047-2015-00918
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K#:K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility,foreign,health professiona
• Reporter Occupation: Other
• Report Date: 09/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem 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?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/02/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/10/2012
• 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