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

Model Number CYF-5

Device Problem Device Reprocessing Problem (1091)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

As part of our investigation, the technical assistance center (tac) informed the customer that the scope should not be reprocessed in the tube as it cannot be completely disinfected and is not in accordance with the manufacturer's recommendations.The scope needs to be completely submerged in a basin in order to properly disinfect.Tac offered the customer a reprocessing in-service with an endoscopy support specialist (ess) to observe the facility¿s reprocessing methods and to provide training.The customer declined the ess visit at this time.In addition, tac emailed the customer the wall chart that shows a picture of the scope completely submerged versus how the cystoscope placed in the tubes with parts not submerged and recommended that the customer contact olympus if the facility is open to the reprocessing in-service at a later date.Furthermore, tac reviewed the previous in-service notes for this customer and was unable to locate any mention of the cleaning tubes being used so the duration of use is unknown.The customer did not provide specific serial number for the referenced scope; therefore, it is unknown if the scope was returned to olympus for evaluation/service and a review of the instrument¿s history could not be performed.The instruction manual provides the statement below to mitigate patient risk.Reprocessing and storage these instruments were not disinfected or sterilized before shipment.Before using these instruments for the first time, reprocess them according to the instructions in chapter 5, ¿reprocessing: general policy¿ through chapter 7, ¿cleaning, disinfection and sterilization procedures¿.After using the instrument, reprocess and store it according to the instructions in chapters 5, through chapter 9.Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.

Event Description

The service center was informed that the user facility was improperly reprocessing the cystoscope.The user facility reported that the scope was not being completely submerge during reprocessing.The scope was being placed in a cleaning tube(model/lot# unk) which allowed portions of the scope to remain exposed.There was no patient infection, patient involvement or device positive culture reported.

Manufacturer Narrative

This supplemental report is being submitted to provide the lm investigation.The legal manufacturer (lm) reviewed the content of this complaint for further investigation.The legal manufacturer reported that the root cause could not be determined.As the results of the dhr review, it was confirmed that there was no abnormality in manufacturing, concession, and variation.It was confirmed that there was no unevenness.The lm reported that the most probable causes for the reported event are as follows: this event is assumed to be due to the handling factor (human error) of your facility.The legal manufacturer confirmed of the contents of the instruction manual> important information ¿ please read before use: reprocessing and storage: this instrument was not disinfected or sterilized before shipment.Before using this instrument for the first time, reprocess it according to the instructions given in chapter 5, "reprocessing: general policy" through chapter 8, "cleaning and disinfection equipment".After using this instrument, reprocess and store it according to the instructions given in chapter 5 through chapter 9.Improper and/or incomplete reprocessing or storage can present an infection control risk, cause equipment damage or reduce performance.7.6 high-level disinfection: all disinfection steps should be performed with the endoscope and all equipment completely immersed.If the equipment is connected or disconnected while not immersed, disinfectant solution may not adequately contact all surfaces of the equipment.

• 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
• MDR Report Key: 10904933
• MDR Text Key: 227887239
• Report Number: 8010047-2020-09466
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K032092
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup
• Report Date: 01/25/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/25/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-5
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/28/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1