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

Model Number TJF-160VF

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Information (3190)

Event Date 10/14/2018

Event Type  malfunction  

Manufacturer Narrative

The reported scope was not returned to olympus for evaluation.The cause of the reported event could not be determined, however, if additional information becomes or if the device is returned at a later date, this report will be updated and supplemented accordingly.

Event Description

Olympus was informed that during a post market surveillance study the scope cultured positive for the following microorganisms: neosartorya fischeri and hamigera avellanea after reprocessing.There were no associated patient infections reported.The olympus endoscopy support specialist (ess) reported that the cleaning and disinfectant solutions used with the endoscope are medivators intercept and peracetic acid steris.The minimum effective concentration is being checked before reprocessing each scopes.During manual cleaning, the endoscope channel is being brushed using a single use, endochoice hedgehog brush.Pre-cleaning is being performed by following ifu recommendations.All scopes are being leak tested using olympus mu-1.The user facility utilizes the steris 1e automated endoscope reprocessor (aer) and was it reported to break down frequently.It is unknown when the last preventative maintenance was performed on the steris 1e.A training in reprocessing in-service was last conducted by the ess at the user facility on (b)(4) 2018.There have been no reprocessing personnel changes since the last visit.The scopes are stored in a storage cabinet, hanging vertically.

Manufacturer Narrative

This supplemental report is being submitted to make a correction on the procode from feb to fdt.

Manufacturer Narrative

This supplemental report is being submitted to correct the device product code from feb to fdt.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The olympus endoscopy support specialist (ess) visited the user facility to observe the reprocessing technique of the reprocessing technician and found the technician was not following the proper sequence of cleaning and reprocessing and was not performing proper cleaning to the elevator at the distal end area.The technician was not: using olympus channel cleaning/opening cleaning brushes and uses non-olympus brushes.Not using a suction cleaning adapter after brushing channels and is doing this as last step.Not raising and lowering the elevator three times while brushing around elevator and distal end.Not properly brushing the distal end around the elevator with the maj-1534 for the tjf-160vf scope.Not flushing the elevator wire channel with the washing tube prior to using medivator scope buddy on the tjf-160vf scope.Not flushing properly around the elevator with a syringe with detergent and rinse water.The ess concluded by conducting a reprocessing in-service training that included all cleaning, disinfection and sterilization information that is contained in the olympus reprocessing/instruction manual.Additionally, as part of the pms study process, olympus personnel conducted a review of the technique of the sampler who took the sample from the scope.And no deviations were found.

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 summary of the investigation findings are as follows; -the organisms identified were neosartorya fischeri and hamigera avellanea, which are mold and not human resident flora.-some improper aseptic techniques during sampling were reported by the on-site infection control nurse.-multiple deviations were observed during the reprocessing procedure review.The exact cause of the reported event could not be conclusively determined, but this phenomenon was possibly occurred due to following; -probably environmental contamination originating from improper aseptic techniques during sampling because of the type of species observed (microbiological analysis).-while inadequate reprocessing is probably not the primary cause, it cannot be completely ruled out due to the deviations reported (reprocessing procedure review).

• Brand Name: EVIS EXERA 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: 8104504
• MDR Text Key: 129353363
• Report Number: 2951238-2018-00724
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K024033
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,study
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/26/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TJF-160VF
• Device Catalogue Number: TJF-160VF
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: AER-STERIS 1E.; BRUSH-ENDOCHOICE HEDGEHOG.; CLEANING SOLUTION-MEDIVATORS INTERCEPT.; DISINFECTANT-PARACETIC ACID STERIS.; LEAK TESTER-OLYMPUS MU-1.