MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

The subject device in this report has not been returned to omsc for evaluation but was returned to olympus (b)(4).The evaluation is in progress currently.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 as a result of routine microbiological testing by the user facility, following microbes were detected from the sample collected from the subject device.Staphylococcus warneri and staphylococcus cohnii (the total is 2 cfu/endoscope.) other detailed information such as the reprocessing method was not provided.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to olympus europa k.G (oekg).Oekg sent the device to a third-party laboratory for microbiological testing.As the results of testing for the sample collected from the all channels of the subject device was positive as follows; [first time; (b)(6) 2021] micrococcaceae: 1cfu/ 100ml [second time; (b)(6) 2021] coagulase negative staphylococcus: 2 cfu/ 100ml micrococcaceae: 4 cfu/ 100ml.Oekg performed a temporary visual check after receiving the subject device from the third-party laboratory.It was found scratches inside the instrument channel port and instrument channel which could explain these microbes remaining.Oekg suggested the replacement to the user where the parts related to minimum instrument channel, such as the channel port, around control body for the repair.Another microbiological testing will be conducted if the repair is done.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.After olympus europe se & co.Kg (oekg) performed a temporary visual check, it was inspected with following the inspection check list and found as follows; -the instrument channel port inside/outside was scratched -the light guide bundles were damaged though oekg had suggested replacing the parts where related to the instrument channel, such as the channel port, around control body to prevent the positive microbes, the user rejected the repair and requested the subject device back without any repair.So we could not conduct further microbiological testing.The subject device was not returned to olympus medical systems corp (omsc).Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.Based on the report of oekg, omsc determined there was the possibility this phenomenon was attributed to a hotbed of bacteria of the subject device.Although the cause of the hotbed of bacteria could not be identified, the following causes could be inferred from the scratches on inside/outside of the instrument channel port.-the microbes remained due to insufficient cleaning due to scratches on the part due to the handling of the facility and the brush not reaching the back during the reprocess.-the reprocess according to the instruction manual was not sufficiently carried out at the user facility, and it became difficult to remove the contamination in the relevant part, and the cleaning was insufficient, so that the microbes remained.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11900904
• MDR Text Key: 253149797
• Report Number: 8010047-2021-06859
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/20/2021
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1