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

Model Number	JF-140F
Medical Device Problem Code	Microbial Contamination of Device (2303)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The endoscopy service specialist (ess) visited the user facility on may 6, 2019 to observe the reprocessing technique and perform an in-service in reprocessing if necessary.The ess observed the cleaning of the tjf 160vf by the reprocessing technicians an no deviations from the process were observed.The cause of the reported positive culture cannot be determined as the investigation is ongoing.If additional information becomes available, this report will be updated and supplemented accordingly.
Event or Problem Description
The manufacture was informed that during a post market study the scope cultured positive for klebsiella pneumoniae after reprocessing.There was no associated patient infection reported.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the summary of the root cause analysis report for the postmarket surveillance the referenced tjf study.Based on the investigations (microbiological analysis, sampling review, reprocessing procedure review, destructive sample review), the most probable cause of the reported positive culture can be attributed to insufficient reprocessing due to glue condition and/or insufficient reprocessing due to reprocessing procedures are potential causes.
Additional Manufacturer Narrative
The scope was forwarded to an independent laboratory for sterilization and then returned to the service center for service/repairs to have the biopsy and suction cylinder/channels replaced.Due to destructive sampling testing that was performed (the distal end cover, bending section cover, distal end elevator wire and forceps raiser were disassembled) further device analysis could not be performed.The cause of the reported positive culture cannot be determined as the investigation is ongoing.If additional information becomes available, this report will be supplemented accordingly.
Additional Manufacturer Narrative
An engineer was dispatched to the hospital to review the sampling technique of the sampler and the facilitator who took the sample that tested positive.There were no deviations found during the audit.As part of the investigation, the scope was sent to an external expert for destructive sample testing.The destructive sampling identified pseudomonas aeruginosa and candida spp that are categorized high concern organisms.The reported klebsiella pneumoniae was not identified in the initial sampling.Additionally, the external expert visually inspected the distal end of the scope and noted the following bleaching of the glue of the bending section and around the objective lens, missing parts of glue around the light guide lens, presence of hole at the glue around the air/ water nozzle, presence of oxidation at the distal end body.The exact cause of the reported event could not be conclusively determined at this time, because the investigation of this case is ongoing.
Additional Manufacturer Narrative
This supplemental report is being submitted to provide the summary of the root cause for the post market surveillance with the referenced tjf study.There were no deviations observed during the environmental investigation and the automated endoscope reprocessing (aer) machine inspection.The user facility used a medivators dsd edge aer to reprocess the subject scope.Based on the investigations, insufficient reprocessing due to the glue condition due and or insufficient reprocessing procedures cannot be ruled out as a contributory factory of the reported positive scope culture.

• Brand Name: EVIS DUODENOVIDEOSCOPE
• Common Device Name: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• MDR Report Key: 8781821
• Report Number: 2951238-2019-01001
• Device Sequence Number: 19332734
• Product Code: FDT
• UDI-Device Identifier: 04953170066344
• UDI-Public: 04953170066344
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K954451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 05/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: JF-140F
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/14/2019
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 06/17/2019
• Supplement Date Received by Manufacturer: 12/13/2019; 01/17/2020; 04/06/2020; 01/10/2020
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 01/06/2020; 02/04/2020; 04/20/2020; 05/22/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: AER: MEDIVATOR DSD EDGE (SN: UNKNOWN)