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

Model Number TJF-Q180V

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 12/04/2018

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) will be dispatched to the user facility to observe the reprocessing technique of the technicians involved with this scope.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 staphylococcus haemolyticus at a concentration greater than 100 cfu.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information regarding the reprocessing, sampling and re-culturing results and to update the following sections: d10, g4, g7, h2, h3, h6 and h10.Olympus endoscopy support specialist personnel reviewed the reprocessing technique of the user facility.The review noted the following: technician brushed using maj-1888 before using channel opening brush (steps performed out of order).Staff is also not reprocessing suction cleaning adapter between uses.As part of our investigation, clinical endotherapy specialist (ces) was dispatched to the user facility to review the sampling techniques and no deviations was found during the audit.As part of this post market study, the scope was re-cultured.This re-culturing sample tested positive for bacillus amyloliquefaciens / bacillus atrophaeus and micorococcus luteus (total colony count: 2cfu ).As part of the pms study, the scope was sent an independent laboratory for ethylene oxide (eto) sterilization and returned to service center for a physical device evaluation.A visual inspection was performed on the returned device and found a kink and scrape marks inside the biopsy channel when using the service center boroscope.The kink inside the biopsy channel is located at approximately 50mm from the distal end opening and the scrape mark is located inside the biopsy channel near the entrance at the control body side.Service center also used the boroscope to verify the suction channel, however, there were no signs of damages or abnormalities present within.Additionally, there is no foreign material inside either channels (biopsy, suction).The scope passed the leak test.The scope was purchased on march 18 2018, and resold on september 2nd 2018.

Manufacturer Narrative

This supplemental report is being submitted to provide the likely root cause identified by the sampling and culturing study interim report of the tjf-q180v.According to the report, a root cause of this case is following: insufficient reprocessing due to duodenoscope leak is the probable cause.

• 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: 8238612
• MDR Text Key: 132811930
• Report Number: 2951238-2019-00353
• 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,other
• Type of Report: Initial,Followup,Followup
• Report Date: 03/03/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/10/2019
• 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: 05/17/2019
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: MEDIVATORS DSD EDGE.; MEDIVATORS DSD EDGE