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

Model Number CYF-V2R

Device Problem Microbial Contamination of Device (2303)

Patient Problem Unspecified Infection (1930)

Event Date 01/08/2019

Event Type  Injury  

Manufacturer Narrative

Insufficient information regarding the reported event was provided by the user facility.Multiple follow ups were made via telephone and in writing but no information has been obtained.The scope was returned to olympus but the evaluation is in progress.As part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.The cause of the reported event cannot be confirmed.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

Olympus was informed that a patient tested (b)(6) for an unspecified infection after undergoing a procedure.The patient reportedly came in with a fever.The scope was then tested and cultured (b)(6) for an unspecified organism after reprocessing.

Manufacturer Narrative

This supplemental report is being submitted to provide the independent laboratory test results, the physical evaluation results for the subject scope and additional information from the olympus endopscopy support specialist (ess).An olympus ess visited the user facility and provided a reprocessing training per olympus guidelines.The user facility informed the ess the staff was not performing precleaning and leak testing.Endoscopy support specialist demonstrated and informed the importance of reprocessing steps.In addition, the ess performed scope handling and reprocessing in-service for the staff.The ess covered infection control information referenced in the user manual and reprocessing manual.The ess emailed the user facility a copy of the on-track forms for reference.The olympus scope was sent to an independent laboratory for microbial testing.The scope's instrument/suction channel cultured positive for microbacterium lacticum.The scope was then eto gas sterilized and returned to olympus for a physical evaluation the customer returned the olympus scope for evaluation.A visual inspection was performed on the subject scope and there was no sign of foreign substance/stain inside the biopsy channel/port when inspected with olympus boroscope and telescope test equipments.Additionally, there were also no sign of foreign material/stain found on the insertion tube, bending section cover/glue, distal end cover, light guide lens and objective lens.However, the insertion tube is buckled below the protector boot and there is a kink noted inside the biopsy channel wall below the protector boot.In addition, the bending section cover glue was discolored, lifted, cracking and corroded at the distal end side and the bending section cover is also discolored and deteriorated.The scope failed the leak test from a cut/hole on the bending section cover.The damages noted to the bending section can be attributed to handling.A review of the scope¿s instrument history records indicates the scope was purchased on december 11, 2016 with no service/repair records.The scope was repaired and returned to the user facility.The cause of the reported patient infection cannot be conclusively determined, however, based on olympus¿s investigations the potential cause of the reported event can be attributed to insufficient/improper reprocessing of the scope.As a preventive measure, the reprocessing manual states: if the endoscope is not immediately precleaned after procedure, residual organic debris will begin to solidify and it may be difficult to effectively reprocess the endoscope.Preclean the endoscope at bedside in the procedure room immediately after each procedure.After precleaning, perform a leakage test on the endoscope to ensure that it is waterproof by using the leakage tester mb-155 or wa23070a.Do not use a damaged or leaking endoscope.Use of a damaged or leaking endoscope may pose an infection control risk to the patient and operators.

Manufacturer Narrative

On february 18, 2019, olympus received additional information from the user facility.After a cystoscopy procedure on (b)(6) 2019.The patient had symptoms of a urinary tract infection.The patient's infection was treated with amikacin and rocephin.The user facility also reported that the subject scope was not cultured as originally reported.No additional information was reported.The subject scope will be sent to an independent laboratory for bacterial testing and eto sterilization.If additional information becomes available this report will be supplemented accordingly.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from nwb to faj and 510(k) number.

• Brand Name: VISERA CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8313576
• MDR Text Key: 135342542
• Report Number: 2951238-2019-00419
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170287619
• UDI-Public: 04953170287619
• Combination Product (y/n): N
• PMA/PMN Number: K133538
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 04/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: CYF-V2R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/28/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 91 YR
• Patient Weight: 64