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

Model Number CYF-VH

Device Problems Break (1069); Contamination /Decontamination Problem (2895)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/20/2021

Event Type  malfunction  

Manufacturer Narrative

The customer returned three customer-owned endoscopes with serial numbers (b)(4) to olympus (b)(4).The inspection of these devices by (b)(4) confirmed customer specified fault, with degradation and damage evident on the distal end adhesives and insertion tube surface.Major repairs is required.The detailed results of the inspection were as follows.Leakage testing confirmed cyf-vh ((b)(4)) and cyf-vh ((b)(4)) were both leaking from the distal end.Cyf-vh ((b)(4)) was not found to be leaking.Visual inspection confirmed the customer specified fault with several areas of damage on the distal end and bending section rubber adhesives evident.The adhesive was cracked and lifted, with areas of adhesive completely missing.The rear adhesive was missing entirely, exposing the binding underneath.Additional damage was noted on the insertion tube.The clear outer coating of the insertion tube had also deteriorated, exposing the white markings.The insertion tube was damaged and blisters were formed on the white markings.The insertion tube was damaged extensively and had deformed / worn white markings.The angular range of the bending section was insufficient.The customer reported that the endoscopes were reprocessed in the following ways; manual cleaning using ecolab pureclean neutral detergent mechanical cleaning in the bht automated endoscope reprocessor using schulke thermosept detergent schulke thermosept base and schulke thermosept additive was combined to form peracetic acid for disinfection.All stages of the process used ro water.Drying the scopes in a steelco endoscope drying & storage cabinet terminal sterilisation of the wrapped scope using gas plasma sterilisation (hydrogen peroxide) using an asp sterrad 100nx the exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

A customer has reported two problems with six customer-owned endoscopes and one loan endoscope; the adhesive on the distal end had deteriorated and was cracked.The customer believed that this was a phenomenon that occurred over time and worsened with each reprocessing of the endoscope.Black residues formed at the distal end.This issue has been reported by this customer in the past.This issue was initially thought to be due to an issue with the customers hot water system.According to previous olympus analysis, black deposits did not originate from the scope component.However, this time, it was reported that the problem recurred.Therefore, this problem has not been solved.There was no report of patient injury associated with this event.This mdr reports about the loan endoscope.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Device inspection by olympus keymed (okm) revealed no defects other than those reported in the initial mdr.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.The exact cause of the reported event could not be conclusively determined.However, olympus medical systems corp.(omsc) assumed that the adhesive defect in the distal end was caused by coating deterioration due to chemical stress.The chemical stress may have been caused by cleaning agents used or insufficient rinsing of the endoscope.And omsc also assumed that the event that black residues formed at the distal end was caused by foreign matter adhering to the distal end was adsorbed by gas sterilization or sterrad sterilization.The foreign matter adhering to the distal end may have been caused by insufficient reprocessing.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The customer provided additional information about the device reprocessing method and confirmed the following: the device was wiped with lint-free gauze.The device was leakage tested using the olympus maintenance unit mu-1 and was disconnected from the leakage tester after the leakage test.The device was fully washed in the sink and manually disinfected using sekusept.And the device was rinsed, then wiped dry with a towel.No alcohol flush was done.The device was mechanically cleaned using reverse osmosis water with the automatic program of a non-olympus automated endoscope reprocessor, innova from bth.There was no problem with the automated endoscope reprocessor innova, and there was no device that was reprocessed by the automated endoscope reprocessor innova other than cyf-vh.The device was sterilized using hydrogen peroxide (h2o2) in the flex cycle of the asp sterilizer, asp sterrad 100nx.The device was sterilized for each procedure.Based on the additional information about the reprocessing method provided by the user facility, olympus medical systems corp.(omsc) conducted the investigation again.However, omsc could not conclusively determine the exact cause of the adhesive defect in the distal end, because the cleaning agents, disinfectants, and cleaning machines used in the user facility are products that are not guaranteed in the instruction manual and have not been verified.Since the coating has deteriorated due to chemical stress, reprocessing may be insufficient due to the influence of the cleaning agent used.In addition, the instruction manual provide precautions when using an automated endoscope reprocessor or cleaning machine that is not recommended by olympus.If significant additional information is received, this report will be supplemented.

• Brand Name: CYSTO-NEPHRO VIDEOSCOPE
• Type of Device: CYSTO-NEPHRO VIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 11330479
• MDR Text Key: 233376283
• Report Number: 8010047-2021-02647
• Device Sequence Number: 1
• Product Code: FAJ
• Combination Product (y/n): N
• PMA/PMN Number: K062049
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 06/10/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CYF-VH
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/17/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1