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

Model Number CYF-VA2

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

Patient Problem Unspecified Infection (1930)

Event Date 06/22/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.Since the serial number of this device is unknown and omsc could not confirm the manufacturing history (dhr).The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that three patients developed fever after cystoscopy using an olympus cysto-nephro videoscope (cyf-vha or cyf-va2).First patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-vha) on (b)(6) 2019.It was reported that the patient developed fever on (b)(6) 2019.Second patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-vha) on (b)(6) 2019.It was reported that the patient developed fever on (b)(6) 2019.Third patient: the patient underwent cystoscopy using an olympus cysto-nephro videoscope (cyf-va2) on (b)(6) 2019.It was reported that the patient developed fever on (b)(6) 2019.The three patients¿ condition is currently unknown.The olympus cysto-nephro videoscope (cyf-vha and cyf-va2) had been reprocessed with an olympus automated endoscope reprocessor, oer-4 (not available in the usa), using peracetic acid.It was reported that forceps/irrigation plug was not completely disassembled during reprocessing.Omsc is submitting three medical device reports according to the number of the patients.This is three of three reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device in this report was returned to olympus medical systems corp.(omsc) for evaluation.Omsc evaluated the subject device and confirmed as follows; the outlet of the instrument channel was dirty.The outer coating of the insertion tube was peeled partially.The adhesive of the rubber of the bending section was peeled partially.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• 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: 8835740
• MDR Text Key: 152544084
• Report Number: 8010047-2019-02722
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,health profession
• Type of Report: Initial,Followup
• Report Date: 12/24/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/29/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/24/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other