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

Model Number TJF-Q180V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The manufacturer followed up multiple times with the user facility via telephone and in writing to obtain additional information regarding the reported patient infection but with no results.As part of the investigation, an endoscopy support specialist (ess) visited to the user facility on may 10, 2019 to provide a reprocessing training.The ess completed a clean disinfection and sterilization/care and handling in-service on a tjf-q180v endoscope with the staff.In-service included all cleaning, disinfecting, and sterilization information contained in the instruction manual.Provided repair reduction information.Each attendee performed a return demonstration.The scope was sent to an independent laboratory for microbial testing.The scope was cultured and the test results indicated the scope's culture tested negative.The scope was then ethylene oxide (eto) sterilized and returned to olympus for a device evaluation.A visual inspection was performed on the received condition of the scope.Upon inspection of the instrument channel, a black piece of foreign material was located inside the biopsy channel at approximately 20cm from the insertion tube boot.In addition, a light scrape mark was found along the channel wall near the middle section, and a kink located near the distal end opening.The suction channel was inspected and no damages or abnormalities were found inside.Additionally, both sides of the bending section cover glue, show signs of discoloration and are cracked.The likely cause of the damages noted can be attributed to maintenance.The scope passed the leak test.The scope was repaired and returned to the user facility.A review of the scope¿s instrument history indicates, the scope was purchased on december 20, 2015 and was serviced on september 15, 2018.The exact cause of the reported patient infection could not be confirmed.However, as a preventive measure, the reprocessing manual states, ¿an insufficiently cleaned, disinfected, or sterilized endoscope and/or accessories may pose an infection control risk to the patients and/or operators who contact them." if additional information becomes available, this report will be supplemented accordingly.

Event Description

The manufacturer was informed that four scopes may have been in contact either directly or indirectly with a patient that cultured positive with ¿super bug¿, suspected to be e.Coli.All four scopes that are possibly affected were quarantined and sent to the manufacturer.No additional information was reported.This report is for scope 4 of 4.

Manufacturer Narrative

This supplemental report is being submitted to provide correction and additional information from the olympus endoscopy support specialist (ess).The ess further reported that an observation of the user facility's reprocessing practices were performed and no deviations were noted.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• MDR Report Key: 8640034
• MDR Text Key: 146055456
• Report Number: 2951238-2019-00878
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170339967
• UDI-Public: 04953170339967
• 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
• Report Date: 06/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2019
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/26/2019
• Initial Date FDA Received: 05/24/2019
• Supplement Dates Manufacturer Received: 05/23/2019
• Supplement Dates FDA Received: 06/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE: GIF-1TH190, SERIAL: (B)(4); SCOPE: PCF-H190DL, SERIAL: (B)(4); SCOPE: TJF-Q180V, SERIAL: (B)(4); SCOPE: GIF-1TH190, SERIAL: (B)(4); SCOPE: PCF-H190DL, SERIAL: (B)(4); SCOPE: TJF-Q180V, SERIAL: (B)(4)
• Patient Outcome(s): Required Intervention