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Model Number CYF-VH
Device Problems Device Reprocessing Problem (1091); Failure to Clean Adequately (4048)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
This is the first of two associated medwatch reports filed for this event. Two devices were involved in this in-service event. Due diligence for additional information was executed. During the in-service, recommendation was given to all staff to follow all olympus reprocessing procedures as documented in the ontrack forms and reprocessing manuals. The customer gave additional information and update for this event. The device has not been cultured. The cleaning and disinfectant solutions being used with the device are organisol and aldahol. The aldahol is changed every two weeks. It is unknown what type of aer is being used to reprocess the endoscopes. The endoscope channel is being brushed during manual cleaning. The brush is reusable. It is disinfected like the device. The model and manufacturer of the brush is unknown. Pre-cleaning is being performed immediately after a procedure. The scope is cleaned with organisol and water, flushed with 10 cc of water/solution, water and air but has changed recently to 30 cc syringe. It is then flushed with the aldahol and soaks for 15 minutes. It is then flushed with sterile water and then air. The endoscope is being leak tested prior to manual cleaning intermittently. There has not been any problems noted with the aer. It is unknown when the previous reprocessing in-service was provided. There has been a change in the reprocessing. A 30 cc syringe is being used, pressure testing, irrigation plug breakdown. It is unknown whether there has been a change in the personnel. All reprocessing personnel are trained on how to properly reprocess an endoscope. The scope is being stored on sterile drape. The device is not returned, as such a definitive root cause of the reported complaint cannot be determined at this time. Supplemental report(s) will be filed as the information becomes available.
Event Description
As reported for this event, during reprocessing for an in-service the reprocessing steps were not being followed per requirement. Pre-cleaning steps are not performed at bedside. The device was not leak tested. Not the 30ml syringes but a different size syringe is used while performing the flushing steps during manual cleaning and high level disinfection cleaning. The entire device is not submerged in the disinfection solution. The forceps/irrigation plug is recently is off late being taken them off but only cleaned on the weekends. There is no adverse impact or harm to any patient. Two devices are involved in this in-service.
Manufacturer Narrative
The device is not returned, as such an actual device evaluation is not performed. Evaluation is done by historical records and communication. This supplemental report is being submitted to provide this information. Please see the updates. The device history record review confirmed that device has no abnormalities, special adoption, or variations in manufacturing. The device was shipped under normal shipping conditions. Endoscopy support specialist (ess) visited the user facility and the customer communication, the following is known: facility does not perform bedside irrigation. Facility does not always perform a scope leak test. The entire scope is not immersed when the scope is immersed in a disinfectant solution for high-level disinfection. Reprocess personnel at facility are trained in how to properly reprocess the endoscope. It is unclear whether there was a shift in personnel at facility. Scope culture test was not performed. However, since device is not returned root cause cannot be determined. The instructions for use includes the following statements for precautions: all disinfection methods (whether performed manually or by an aer/wd) and all sterilization methods (whether performed by ethylene oxide gas or steam) require thorough prior cleaning of the instruments being reprocessed. If the instruments are not adequately cleaned prior to disinfection/sterilization, these processes will be ineffective. Immediately after each patient procedure and before disinfection/sterilization, thoroughly clean the endoscope and the accessories used with the endoscope.
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Manufacturer (Section D)
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
MDR Report Key10704438
MDR Text Key224178381
Report Number8010047-2020-07896
Device Sequence Number1
Product Code FAJ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/18/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/20/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberCYF-VH
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received10/30/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2012
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse