MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. FIBERSCOPE, "CYF-5", UK VERSION; CYSTONEPHROFIBERSCOPE

Model Number CYF-5

Device Problems Break (1069); Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

Event Date 07/15/2019

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) but was returned to (b)(4) for evaluation and repair.The evaluation is in progress.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 were infected with pseudomonas after cystoscopy using the subject device.In addition, it was reported that one of three patients died.However, the relationship between the death and subject device and the infection is currently unknown.The two patients¿ condition other than the expired patient is currently unknown.The user facility returned the subject device to olympus for repair because the subject device did not pass a leakage test.The user facility had cleaned the subject device using a non-olympus single use cleaning brush (mi-cb-sweep-port, cantel) and reprocessed the subject device using a non-olympus automated endoscope reprocessor (medivators rapidaer, cantel), using a non-olympus disinfectant (rapicide part a and rapicide part b, cantel).Omsc is submitting three medical device reports according to the number of the infected patients.This is two of three reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Keymed ltd, (okm) reviewed the service history for the subject device.The subject device was returned to okm on may 23th, 2019 for the most recent repair and there was repair required.Okm sent the device to a third party laboratory for microbiological testing.As the result of the first microbiological testing, the sample collected from the subject device before being reprocessed tested positive for unspecified microbes (>100cfu/swab).Okm reprocessed the subject device and sent it to the laboratory again for the second microbiological testing.As the result of the second microbiological, the sample collected from the subject device tested positive for unspecified microbes (>100cfu/swab).Okm reprocessed the subject device once again after receiving the above results.After that, the subject device was sent to a third party laboratory again for third microbiological testing.As the result of the third microbiological testing, the sample collected from the subject device tested positive for unspecified microbes (7cfu/swab).It was reported that the result of the third microbiological testing was an acceptable level of the unspecified specifications.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.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The subject device was returned to keymed ltd, (okm) on july 18th, 2019.Okm evaluated the subject device and confirmed that there was an air leakage from the bending section.The date of the three microbiological testing reported in the previous follow-up report were as follows; the first microbiological testing: (b)(6) 2019.The second microbiological testing: (b)(6) 2019.The third microbiological testing: (b)(6) 2019.The three microbiological testing were performed on the sample collected from the instrument channel of the subject device.After the third microbiological testing, the subject device was repaired.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

Please see updates to b5.Correction to g2 to add the foreign country united kingdom.Correction to a1, d4, d8, d9, h3, and h6, please see a1, d4, d8, d9, h3, and h6, for further detail.This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The device was evaluated where a leak in the bending section was noted however, the defect is not considered severe enough to cause a potential adverse event.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The legal manufacture reviewed the facilities cleaning, disinfection and sterilization (cds) practices and noted that the device was not dried prior to being stored.Based on the results of the investigation, a root cause could not be determined.Growth of microorganisms were found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, the results conformed to the regulation's recommendation.The following is included in the device ifu: "insufficient cleaning and disinfection or sterilization of the endoscope may pose an infection control risk to the patient and/or operators performing the next procedure with the endoscope." olympus will continue to monitor field performance for this device.

Event Description

Case with patient identifier (b)(6) reports patient 1 of 3.Case with patient identifier (b)(6) reports patient 2 of 3 (this report).Case with patient identifier (b)(6) reports patient 3 of 3.

• Brand Name: FIBERSCOPE, "CYF-5", UK VERSION
• Type of Device: CYSTONEPHROFIBERSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 8854169
• MDR Text Key: 153068302
• Report Number: 8010047-2019-02806
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170339417
• UDI-Public: 04953170339417
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/02/2019
• Is this an Adverse Event Report?: Yes
• 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
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/06/2012
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other