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

Model Number CYF-V2

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

Patient Problem Local Reaction (2035)

Event Type  Injury  

Manufacturer Narrative

The doctor did not know the specific serial number for the referenced scope; therefore, it is unknown if the scope was returned to olympus for evaluation/service and a review of the instrument¿s history could not be performed.The service center did follow up with the user facility to obtain the following additional information: the disinfectant/solution used to reprocess the scope and the patient¿s procedure date; however, this information was not provided.As part of our investigation, the content of this complaint has been escalated to the original equipment manufacturer (oem) for further investigation.This event has been reported by the importer on report # 2951238-2019-01229.

Event Description

The service center was informed by the user facility¿s performing doctor that the patient experiences an allergic reaction after undergoing repeat cystoscopy procedures.Due to a pre-existing condition, the patient must undergo a cystoscopy every three months.The patient experiences swelling of the penis and purple discoloration.The patient has no pre-existing allergies.The patient was given topical cream to treat the reaction.The doctor reported that the patient¿s condition last approximately two or three weeks.The doctor reported that only ky lubricant is used.There are no other lubricants, creams, or soaps used during the procedure.This patient is an isolated case, no other patients have been noted with this reaction.In addition, the user facility reported that they are not 100% sure that this is related to the scope.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received from the original equipment manufacturer (oem).Please see the updates in sections: g4, g7, h2 and h10.The oem reviewed the content of this complaint and reported that since the scope itself uses materials that have passed the biocompatibility test, it is not considered to be due to the scope.The allergic reaction, it is presumed to be factors such as drugs/medicines used in the facility.

• 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-to 192-8 507; JA 192-8507
• MDR Report Key: 9507500
• MDR Text Key: 189053582
• Report Number: 8010047-2019-04509
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170287091
• UDI-Public: 04953170287091
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Type of Report: Initial,Followup
• Report Date: 01/14/2020

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-V2
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 11/27/2019
• Initial Date FDA Received: 12/20/2019
• Supplement Dates Manufacturer Received: 12/22/2019
• Supplement Dates FDA Received: 01/14/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention