MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Microbial Contamination of Device (2303)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Date 11/13/2018

Event Type  malfunction  

Manufacturer Narrative

The scope has not returned to olympus for evaluation.The cause of the reported complaint cannot be confirmed.Currently the investigation is ongoing.As part of our investigation, an olympus endoscopy support specialist (ess) was dispatched to the user facility to observe the reprocessing technique of the technicians involved with this scope.The review found that a third party flushing pump was used in place of the syringe processes described in the manual cleaning, manual high-level disinfection, rinsing and alcohol flush steps.The sampling technique involved in the reported positive culture was also reviewed.No deviations were found.Olympus will continue to investigate and work with the user facility to obtain more specific and detailed information regarding the reported event.If additional information becomes available, this report will be supplemented accordingly.

Event Description

Olympus was informed that during a post market surveillance study, the scope tested positive for enterococcus durans.

Manufacturer Narrative

As part of the post market study, the scope was sterilized and returned to the service center for evaluation.A visual inspection on the scope identified an excess amount of foreign brownish color substance throughout the inside the instrument channel and suction channel.There was no note of foreign substance/materials found on the external areas of the insertion tube, bending section cover, and distal end.As a result of the destructive testing, the scope was received without the distal end cover and the elevator forceps raiser, therefore, a leak test could not be performed.A review of the service history of the scope found three repairs in the past three years, none involving positive culture or a contamination issue in the scope.The cause of the foreign brown colored substance and the reported positive culture cannot be determine at this time as the investigation is ongoing.However, if additional information becomes available, this report will be supplemented accordingly.

Manufacturer Narrative

A review was performed of the sampling technique and circumstances for the sample that tested positive.The review found; cardboard was brought into the room.In addition, ess traveled to customer and performed a complete reprocessing in-service, answering questions related to steps demonstrated.As part of pms study, original equipment manufacturer has requested scope for further investigation.The exact cause of the reported event could not be conclusively determined at this time, because the investigation of this case is ongoing.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information and to update the following sections: g4, g7, h2, h6 and h10.As part of the pms study process, scope inspection was performed at third party laboratory.Below is the summary case report for this scope.The destructive sampling identified following microorganisms that are categorized high concern organisms.-sphingomonas melonis -sphingomonas spp.-burkholderia cepacia or mycobacterium neoaurum -sphingomonas paucimobilis or paenibacillus amylolyticus -brevundimonas diminua or burkolderia cepacia or pseudomonas oryzihabitans -paenibacillus amylolyticus none of the organisms was identified in the initial sampling.After the disassembling, the following was observed.-a leak from the scope -bleaching of the glue.

Manufacturer Narrative

This supplemental report is being submitted to provide the final report for the postmarket surveillance tjf-q180v study.Based on the investigations conducted, the most probable cause of the reported event was attributed to insufficient reprocessin; due to duodenoscope leak.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8188040
• MDR Text Key: 131489962
• Report Number: 2951238-2018-00783
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 01/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/20/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/21/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDIVATORS DSD EDGE; OLYMPUS BW-412T BRUSH; UNKNOWN THIRD PARTY FLUSHING PUMP