MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. OES CYSTONEPHROFIBERSCOPE

Model Number CYF-5R

Device Problem Device Handling Problem (3265)

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

Event Date 01/10/2023

Event Type  malfunction  

Manufacturer Narrative

The actual device is not available for evaluation.Evaluation is performed with communication and historical records.Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria at the time of shipping.In an in-service performed at the facility for the device, the olympus endoscopy support specialist (ess) noted that the customer did not follow the recommendations for reprocessing as described in the reprocessing manual for the device.Based on the observations, ess has made the following recommendations to the customer, so that reprocessing at the facility is aligned with the instructions for use (ifu): ess demonstrated proper reprocessing steps beginning with bedside pre-cleaning through high level disinfection to the facility staff.Ess recommended that the customer purchase a leak tester as soon as possible and that the customer purchase the appropriate size basin for reprocessing and the appropriate cleaning brushes.Ess recommends that the scope be stored in a well ventilated cabinet or container after reprocessing.Ess recommended a follow up in-service.It is verified that the ifu includes: -recommendation for performing a leak test after cleaning the bedside in order to secure watertightness of an endoscope.(reference: chapter 7 cleaning, disinfection and sterilization procedures_7.4 leakage testing) -bw-15b and mh-507 recommended cleaning brushes.(reference: chapter 7 cleaning, disinfection and sterilization procedures_7.1 required reprocessing equipment) -recommended cleaning, sterilizing, and disinfecting reusable parts.(reference: chapter 7 cleaning, disinfection and sterilization procedures_7.9 cleaning, disinfection, and sterilization procedures for reusable parts and cleaning equipment).The instructions for use includes the following statements: channel cleaning brush (bw-15b) the channel cleaning brush is used to brush the inside of the instrument and suction channels channel-opening cleaning brush (mh-507) the channel-opening cleaning brush is used to brush the suction cylinder and the instrument channel port 7.4 leakage testing after precleaning, perform leakage testing on the endoscope to ensure that it is waterproof.7.9 cleaning, disinfection, and sterilization procedures for reusable parts and cleaning equipment this section includes the cleaning, disinfection and sterilization procedures for the reusable parts and reprocessing equipment listed below.For all other parts, refer to their respective instruction manuals.For compatible reprocessing methods, refer to section 6.1, ¿compatibility summary¿.Clean, disinfect and sterilize the forceps/irrigation plug according to the instructions given in its instruction manual.Sterilization [caution] the cleaning brushes are not compatible with eto gas sterilization.

Event Description

In an in-service performed at the facility for the device, the olympus endoscopy support specialist (ess) noted that the customer did not follow the recommendations for reprocessing as described in the reprocessing manual for the device.Customer did not perform a leak test and does not have the appropriate handheld leak tester.The customer did not use the appropriate brush for cleaning during the cleaning process.The brush is not a reusable brush and is not being sterilized after use.Customer is not using the appropriate size basin or sink when washing scopes and is washing scopes with other instruments inside the basin.There is no harm to any patient due to this event.Customer is not storing scopes in a recommended well ventilated cabinet.Scopes are being stored on the counters wrapped in a pad in the patient procedure rooms.

• Brand Name: OES CYSTONEPHROFIBERSCOPE
• Type of Device: CYSTONEPHROFIBERSCOPE
• 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 961-8 061; JA 961-8061
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16282268
• MDR Text Key: 308622950
• Report Number: 3002808148-2023-00991
• Device Sequence Number: 1
• Product Code: FAJ
• UDI-Device Identifier: 04953170328817
• UDI-Public: 04953170328817
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K221690
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/10/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/19/2021
• 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