MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. RHINO-LARYNGO VIDEOSCOPE

Model Number ENF-VT2

Device Problems Device Reprocessing Problem (1091); Microbial Contamination of Device (2303)

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

Event Date 11/22/2022

Event Type  malfunction  

Event Description

The customer reported to olympus, the rhino-laryngo videoscope tested positive for an unexpected contamination of mold.The distal end was sampled.The issue was found during a routine culture of the scope.The user did not report any contamination or any other serious deterioration in state of health of any person, to which the scope could have been a contributory cause.

Manufacturer Narrative

The suspect device has been returned to olympus for evaluation and the investigation is ongoing.The physical device evaluation has not been completed.Prior to the device evaluation, the device was sent out for additional microbiological testing.The customer provided the cleaning, disinfection, and sterilization process.The instrument/suction channel were aspirated and flushed with water.Reprocessing was delayed and manual cleaning was not performed within an hour of the procedure.The scope was presoaked and passed the leak test.The instrument channel was manually brushed.The automated endoscopic reprocessor (aer) used is asp endocleanse.The aer detergent is endopure and the aer disinfectant is disopa.The scope was dried with the dry process of the aer and was wiped clean with a clean towel/paper.The endoscope was not stored.The cleaning, disinfection, and sterilization (cds) was performed by the customer.There was no patient infection.The hygiene microbiological investigation report indicated the channels of the scope were cultured and there was no mold cultured.The results obtained comply with the target level for an endoscope subjected to high level disinfection and rinsed with sterile water.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was evaluated where no abnormalities were found that could have led to the positive culture.Defects were noted where the following were noted: the flexible tube of the insertion section is crushed due to external factors.The bending angle is insufficient due to the elongation of the angle wire.The curved rubber adhesive part is missing.Discoloration of the illumination lens is noted.Scratches were found on the insertion tube, operation part, operation unit cover, grip, angle lever, universal cord, video cable, video connector, light guide connector and the video connector case due to external factors.However, these defects alone are 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.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 instruction manual of enf-vt2 describes the reprocessing methods in the following chapters: chapter "compatible reprocessing methods and chemical agents".Chapter "cleaning, disinfection, and sterilization procedures".Olympus will continue to monitor field performance for this device.

• Brand Name: RHINO-LARYNGO VIDEOSCOPE
• Type of Device: RHINO-LARYNGO VIDEOSCOPE
• Manufacturer (Section D): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima 961-8 061; JA 961-8061
• Manufacturer (Section G): SHIRAKAWA OLYMPUS CO., LTD.; 3-1 okamiyama; odakura, nishigo-mura,; nishishirakawa-gun, fukushima
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16357613
• MDR Text Key: 309666321
• Report Number: 3002808148-2023-01299
• Device Sequence Number: 1
• Product Code: EOB
• UDI-Device Identifier: 04953170339509
• UDI-Public: 04953170339509
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K061313
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: ENF-VT2
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/25/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/20/2015
• 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
• Treatment: KV-5.; LMD-X310S.; MAJ-209.; OTV-SI2.