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

Model Number CYF-VH

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 07/22/2019

Event Type  Injury  

Manufacturer Narrative

The subject device in this report has not been returned to olympus medical systems corp.(omsc) for evaluation.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 five patients were infected with proteus mirabilis after cystoscopy using the subject device.The procedure date of the five patients were as follows; first patient: (b)(6) 2019.Second patient: (b)(6) 2019.Third patient: (b)(6) 2019.Forth patient: (b)(6) 2019.Fifth patient: (b)(6) 2019.The five patients were treated with antibiotics.It was reported that the subject device had been reprocessed by the user facility as following procedures; the leakage test was performed on the subject device, and subject device was rinsed with water and wiped off.The subject device was immersed in a non-olympus detergent solution (deconex 53 plus, borer chemie ag) for 15 minutes, and cleaned using an olympus channel cleaning brush (bw-15b) and channel-opening cleaning brush (mh-507).The subject device was flushed using a non-olympus syringe (deconex, borer chemie ag).The subject device was rinsed with water.- the subject device was immersed in a non-olympus disinfectant solution (deconex hld pa20, borer chemie ag) for 3 minutes, and flushed using a non-olympus syringe (deconex, borer chemie ag).The subject device was rinsed with a non-olympus alcohol (aquadest).The subject device was dried using an air blower.The user facility conducted microbiological culturing testing on subject device.In the testing, the sample collected from the subject device tested positive for proteus mirabilis (the number of microbe is unknown).Omsc is submitting five medical device reports according to the number of the infected patients.This is three of five reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.It was reported the five patients were recovered after the five patients were treated with antibiotics for one week.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus europa se & co.Kg (oekg).Oekg sent the subject device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the distal end unit and the instrument channel of the subject device.After the additional testing, oekg evaluated the subject device and confirmed that the insertion tube of the subject device was slightly kinked.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

• 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 192-8 507; JA 192-8507
• MDR Report Key: 9080380
• MDR Text Key: 161966612
• Report Number: 8010047-2019-03309
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other