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

Model Number CYF-VA2

Device Problem Device Reprocessing Problem (1091)

Patient Problem Fever (1858)

Event Date 07/17/2012

Event Type  Injury  

Manufacturer Narrative

Olympus medical systems corp.(omsc) performed mdr retrospective review and found that this initial report is required on december 24, 2015.This initial report is being submitted to provide additional information and the evaluation result of the subject device.Because olympus confirmed that there were 5 patients involved in the reported event, olympus will submit additional 4 initial mdrs to account for the total of 5 patients.(please cross reference 8010047-2012-00223, 8010047-2016-00177, 8010047-2016-00178, 8010047-2016-00179) olympus followed up with the user facility to obtain additional information regarding this report.The user facility reported that the three patients were admitted but have already been discharged.The other two patients were diagnosed with noninfectious pyrogenic urethritis.The subject device was returned to olympus for evaluation.The evaluation found a slight residue in the instrument channel port and the distal end.Omsc disassembled the subject device for evaluation.As a result of the disassembly evaluation, kink and perforation were found in the instrument channel.The kinked instrument channel is surmised to be caused by the deflected insertion tube.Because the instrument channel became narrower due to the kink, it is considered that interference between an instrument and the instrument channel increased upon insertion of the instrument, and it lead to the perforation.Trace of water invasion was noted inside the control section.Omsc conducted a composition analysis on foreign material noted on the subject device.As the result of the composition analysis of the foreign material found on the instrument channel port, o (oxygen) and slight amount of cl (chlorine) were detected in addition to stainless steel, the base metal.It suggests that a part of the instrument channel port was corroded by tap water or some other factors.As the result of the composition analysis of the white foreign material found on the distal end, na (sodium) and cl (chlorine) were detected.They are seemingly the residue of cleaning detergent, etc.As the result of the composition analysis of the black foreign material found on the distal end, c (carbon), sn (tin), p (phosphorus), si (silicon), and cl (chlorine) were detected.It was confirmed that they were to be the same element as the antifriction material used inside the subject device.Based on the above, the exact cause of the reported event could not be conclusively determined, but inadequate user reprocessing, inadequate maintenance, or user handling could not be ruled out as a contributory factor.

Event Description

The user facility reported that five patients returned to the user facility complaining of fever after having undergone a cystoscopy.The patients were provided with unspecified antipyretic treatment.

• Brand Name: OLYMPUS VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP; 2951 ishikawa-cho; hachioji-shi; tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: kunimori yamaguchi ; 2951 ishikawa-cho; hachioji-shi; tokyo ; JA
• MDR Report Key: 5385192
• MDR Text Key: 36624881
• Report Number: 8010047-2016-00176
• Device Sequence Number: 0
• Product Code: FAJ
• Reporter Country Code: JA
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/22/2016
• Is this an Adverse Event Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VA2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/20/2012
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 07/17/2012
• Was Device Evaluated by Manufacturer?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other