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

Model Number CYF-5

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Date 08/26/2020

Event Type  Injury  

Manufacturer Narrative

The device was returned to olympus and evaluation is pending, as the device was sent to an off-site laboratory for microbiological testing.As part of our investigation into this report, an olympus endoscopy support specialist (ess) was dispatched to the user facility to assess the user facility¿s reprocessing practices, and provide reprocessing training if necessary.On november 13, 2020 an olympus ess visited the user facility to perform a scope reprocessing and infection control in-service for the staff.The ess covered infection control information referenced in the user manual and reprocessing manual.In addition, the ess requested the facility staff to show him each step in the use and reprocessing of the scope.Based on the ess' observation the facility staff was not currently using correct transport bins, not pre-cleaning, not leak-testing after each case, not currently reprocessing stopcock, not currently replacing saline bag or irrigation tubing between each case, not currently reprocessing reusable brushes, not currently soaking scope in detergent for the recommended amount of time, and not currently properly rinsing scope.The ess communicated these findings to the facility staff, and provided them a list recommended proper reprocessing techniques and proper handling and storage of the device.The ess recommended the use of disposable ancillary equipment and to consider using the gluteraldehyde based disinfectant, such as aldahol 1.8.This report will be supplemented when new information becomes available.

Event Description

The attending physician reported that there were nine patients that were examined by the same cystoscope.After the procedure, the patients' urine samples were cultured and an esbl e.Coli had been recovered on those patients' urine sample.The patients were treated with antibiotic.The cystoscope was returned to olympus for evaluation to see if there had been any damage on the device.According to the physician, some of the patients have had urine retention, hematuria, septic issues, and uti after the procedures, which triggered him to have the patients' urine be cultured.In addition, it was reported that the device has been manually reprocessed and soaked in cidex opa (disinfectant).The user facility further reported that there had been no device culture performed prior to returning the device to olympus.This is for patient #6 and this is 6 of 9 reports.Cross-reference related reports: (b)(4).

Manufacturer Narrative

This supplemental report is being submitted to provide additional information based on the laboratory results and results of device evaluation: based on the laboratory report there was no microorganism recovered from the device.The device was gas sterilized prior to returning the device to olympus.The device instrument channel was examined with the use of a borescope, and found large kinks, stains, and scrape marks in the instrument channel.Additionally, there was a foreign material build-up on the body grip.There was a discoloration of the insertion tube, and more foreign build-up on the bending section cover near the adhesive area.The bending section cover is also torn which caused the device to failed the leak test.There were 16 broken image fibers.A review of the instrument history revealed that the device was purchased on august 21, 2010 with no service events after.This is the first service event for the subject device; the device was refurbished and returned to the user facility.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 13 years since the subject device was manufactured.Based on the results of the investigation, the following causes have been identified: the cause of the positive culture test and suspected cross-contamination was likely from the user deviating from the reprocessing instructions for use.The cause of large kinks, dirt, stains, and scrape marks inside the biopsy channel was likely damaged due to insertion and removal stress of the endotherapy accessories during the procedures.The cause of the foreign build-up on the bending section cover near the glue was likely from inappropriate reprocessing.The cause of the bending section cover torn and leaking was likely from user handling of the device.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

This report is being supplemented to provide additional information from the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been over 14 years since the subject device was manufactured.Based on further investigation findings, although foreign material was confirmed to be adhered to the grip, the specific material could not be identified.In addition, it was also confirmed that dirt was inside the biopsy channel.However, the details about the dirt could not be identified.Both the foreign material and the dirt likely remained due to deviation of reprocessing from the instructions for use (ifu) manual.Furthermore, the root cause of both events could not be determined.The event can be detected/prevented by following the ifu which state: ¿preparation and inspection of the endoscope" instructs user to inspect the appearance of the insertion section and the insertability of the biopsy ch.Based on multiple abnormalities of the subject device confirmed in investigation results 1-4, it is judged that there were deviations from the inspection procedure given in ifu.¿ this supplemental report includes correction to e2, e4, and h4 from initial medwatch.Also, 26aug2020 was inadvertently added to b3 on initial medwatch.This date is incorrect and the event date is unknown.Olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 24-aug-2020.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 10934579
• MDR Text Key: 219983469
• Report Number: 8010047-2020-09726
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170411144
• UDI-Public: 04953170411144
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 12/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/12/2008
• 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
• Patient Age: 66 YR
• Patient Sex: Male
• Patient Weight: 81 KG