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

Model Number CYF-VA2

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 12/19/2017

Event Type  Injury  

Manufacturer Narrative

The two cyf-va2 were returned to omsc for evaluation.The evaluation found following failures.[cyf-va2, s/n (b)(4), manufactured on september 13, 2015].- there were kinks in the instrument channel and the insertion tube.- there were debris and scratches inside of the instrument channel.- there were scratches on the rubber of the bending section.- the part of the coating over the insertion tube was peeling off.[cyf-va2, s/n (b)(4), manufactured on november 11, 2010].- there were kinks in the instrument channel and the insertion tube, the universal cord and the instrument channel.- there were scratches inside of the instrument channel.- there were scratches on the rubber of the bending section and the adhesive of bending rubber.- there was debris on the universal cord.Omsc reviewed the manufacture history of the two cyf-va2 and confirmed no irregularity.The exact cause could not be determined at present, if significant additional information is received, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that 8 patients had a fever after a cystoscopy using subject device.The 8 patients reportedly experienced cystoscopy between (b)(6) 2017 and (b)(6) 2018.The facility provided unspecified medical treatment for the patients, but there was no information of the outcome.The facility possesses two cyf-va2 (serial number: (b)(4)), but it is unknown which scope was used for each patient.The user facility conducted microbial culture test for two cyf-va2 and the testing indicated no microbial growth for the two cyf-va2.The user facility reported that the subject device had been reprocessed using endostream, a non-olympus automated endoscope reprocessor model, this report is 2 of 8 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide the additional device evaluation result.The additional evaluation of the two cyf-va2 by omsc confirmed following.[cyf-va2, s/n (b)(4)].There was a pinhole on the rubber of the bending section.The bending angle does not meet the specification.The remote switch 4 did not work.There were residual substances of water inside of the control section, universal cord and the light guide lens.There were air leakages at the instrument channel and the rubber of the bending section.When inserting an endotherapy accessory into the instrument channel, stuck was felt at the bending section and under the boot.When inserting a channel cleaning brush into the instrument channel, stuck was felt at the bending section.There was a kink at the bending section.There was debris around the instrument channel port.[cyf-va2, s/n (b)(4)].There was debris inside of the instrument channel.The exact cause could not be determined.This report is 2 of 8 reports.

Manufacturer Narrative

This supplemental report is submitting to correct "device product code" and "pma/510(k) number".

• 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
• MDR Report Key: 7243340
• MDR Text Key: 99072329
• Report Number: 8010047-2018-00149
• 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: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 02/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2018
• 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: 01/18/2018
• 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