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

Model Number CYF-VHA

Device Problem No Apparent Adverse Event (3189)

Patient Problem Inflammation (1932)

Event Type  Injury  

Manufacturer Narrative

The subject device was returned to olympus for evaluation.The evaluation confirmed foreign materials within the instrument channel port and a deformation in the instrument channel of the subject device.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity the exact cause could not be determined at present, but the insufficient reprocessing by the user facility cannot be ruled out as the cause of this event.

Event Description

Olympus medical systems corp.(omsc) was informed that three of six patients, who undergone unspecified cystoscopy with the subject device, suffered mild prostatitis since they purchased the subject device on (b)(6) 2018.It was reported that the three patients were treated with antibiotic and in good condition after the procedure.The facility reported that they had used another cystoscope before (b)(6) and there was no prostatitis.Omsc followed up with the facility to obtain additional information.The facility reported that they manually reprocessed the subject device using glutaraldehyde and the subject device passed the leakage test during reprocessing.In addition following deviations from the instructions of the subject device were reported from the facility.The facility did not use medical detergent solution but a detergent solution for household.They did not attached adapter to the channels of the subject device during the reprocessing and they rinsed the channels directly using running water.This is two of three repots.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Omsc conducted analysis for the brown foreign material found on the instrument channel port of the subject device.The result of ft-ir (fourier-transform infrared spectroscopy) analysis indicated components originated carboxylate salt and hydroxide.Edx (energy-dispersive x-ray spectroscopy) analysis detected fe, cr and ni.The analysis for the foreign material on the forceps/irrigation plug, which was used with the subject device in the user facility, showed the same result as the instrument channel port.Based on the result of the analysis and the color of the foreign material, it is concluded that the foreign material is possibly composed of the rust of the instrument channel port and a material originated from medical agents such as detergent solution.The exact cause could not be determined at present, but the insufficient reprocessing by the user facility cannot be ruled out as the cause of this event.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code".

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 7640790
• MDR Text Key: 112412631
• Report Number: 8010047-2018-01226
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup,Followup
• Report Date: 02/26/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/27/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VHA
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 02/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other