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 Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

The device has not been returned to omsc but was returned to olympus (b)(4).(b)(4) sent the device to a third party laboratory for microbiological testing.As a result of the testing, no microbe was detected from the sample collected from the distal end and the forceps elevator, the suction, the instrument, the air/water channels of the device.The testing result cleared the german guideline.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that as a result of multiple microbiological testing by the user facility, the following microbes were detected from the sample collected from the auxiliary water channel of the subject device.[first time; (b)(6) 2020] burkholdelia cepacia (1 cfu), serratia marcescens (10 cfu), enterobacter erogenes (9 cfu).[second time; (b)(6) 2020] shigella spp.(2 cfu), acinetobacter lwoffii (8 cfu).The device had been manually reprocessed using peracetic acid.The user facility has not used the device since (b)(6) 2020.On jan 14, 2021, olympus was informed from the user facility that one patient who had a procedure using the device was infected with klebsiella pneumoniae carbapenemasi.The user facility did not provide other detailed information.

Manufacturer Narrative

Olympus medical systems corp.(omsc) was obtained the following additional information from the user facility.The patient was already infected with klebsiella pneumoniae carbapenemasi before the ercp procedure using the device.There is no problem currently with the patient's health.The device had been reprocessed using soluscope 4 and peracetic acid.The device was not returned to olympus medical systems corp.(omsc), but returned to olympus repair center for evaluation.According to the evaluation, the following was found.The light guide lens and objective lens were partially missing, worn, and tore.The adhesive of the bending rubber was worn out.A part of the insertion tube was deformed.A stain adhered to the control section.There were contaminants at suction cylinders and air/water cylinders.The universal cord and video cable were collapsed, dented, and deformed.Forceps raiser was not moved up completely.There was a stain or discoloration on the distal end of the endoscope.Device history record review indicates that the product was manufactured and tested in accordance with all applicable procedures and met all final product release criteria.The exact cause of the reported event could not be conclusively determined at this time.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Additional details regarding the cleaning, disinfection, and sterilization (cds) of the scope was made available.Olympus confirmed no obvious deviation from the instructions for use from the review of the cds check list sent from the user facility.- aer model name: soluscope set 4 - disinfectant name: soluscope paa - disinfectant type: paa (900 ppm) - was aer water sample hmi tested?: yes, the final rinse water was found to be compliant.- detergent: soluscope cln the additional device defects found during olympus inspection were not considered severe enough to cause a potential adverse event.Based on the results of the investigation, it is unlikely the patient infection/positive culture was caused by the device.Growth of microorganisms was found through culture testing by the user after reprocessing.However, when olympus culture tested after reprocessing in accordance with instructions for use (ifu) before repair, no microorganisms were found.It is possible the user's cds process differed from the ifu, or contamination occurred after microbiological testing.The following is included in the ifu: "reprocessing manual: 1.4 precautions: warning: an insufficiently reprocessed endoscope and/or accessory may pose an infection control risk to the patients and/or operators who touch them." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Correction to g3 of the initial medwatch.The aware date should be 27-dec-2020.Investigation activities have been opened to manage the actions related to this report and any required mdr reporting.

• 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
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 11248933
• MDR Text Key: 233153347
• Report Number: 8010047-2021-01992
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170229503
• UDI-Public: 04953170229503
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 12/05/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/15/2015
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Outcome(s): Other