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 subject device in this report has not been returned to omsc for evaluation.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 a total of six patients were infected with microbes after the procedure using this device.Dna test results on the six patients shows as follows.One patient was infected with unspecified microbes.Two patients were infected with multiresistant citrobacter.Three patients were infected with multiresistant bacteria and klebsiella.The device hadn¿t been cultured since (b)(6) 2020 although the hospital¿s protocol requires weekly test.As a result of microbiological testing by the user facility, citrobacter resistant and klebsiella were detected from the sample collected from the device.The device had been reprocessed with a non-olympus automated endoscope reprocessor, (b)(6), using peracetic acid.The actions taken by the user facility confirmed that the automated endoscope reprocessor and the drying cabinets have no problem.Omsc is submitting three medical device reports according to the number of potentially infected patients.This is 3rd of 6 reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The initial report said that the number of the infected patients is 6, but the actual number is 5, according to the new information.The follow-up figured out that the hospital had a water-quality problem because they hospital had used the same water filter for 12.5 years with no replacement.The water filter was supposed to be replaced once a year.The hospital wants to have an external expert to investigate this event.Olympus continues following-up with them.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

Olympus medical systems corp.(omsc) was informed of the additional microbiological testing by the user facility.As a result of the testing, no microbe was detected from the sample collected from each channel of the device.Olympus europa se & co.Kg (oekg) checked the previous repair history of this device and found that this device has not been repaired in the past.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 supplemental report is being submitted to provide additional information.As part of the investigation, olympus medical systems corp.(omsc) reviewed information on the reprocessing practice of the user facility, and confirmed deviations from the instructions for use of the subject device were found as follows.- the user has not performed flushing the forceps elevator in the detergent solution every time - the air/water channel has not flushed with detergent solution in addition, the device had been reprocessed with a non-olympus automated endoscope reprocessor, wd440pt (wassenburg).It was also confirmed that the brushes for the instrument channel and instrument channel opening are not listed on the compatible list of the instructions for use of the subject device.Additionally, the user facility was visited to observe the reprocessing practice.Deviations from the instructions for use were confirmed.The subject device in this report is not returned to olympus, but is sent to a third party institute for evaluation.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was evaluated at olympus repair center.According to the evaluation, the following was found.-there is a foreign material on the distal end.-water drops came out of the channel.-the user reprocessing of the device was inappropriate.Olympus repair center sent the device to a third-party laboratory for microbiological testing.As a result of the testing, the sample collected from the device tested positive for the following.-bacillus amyloliquefaciens -bacillus altitudinis -staphylococcus saprophyticus -staphylococcus haemolyticus -esbl-positive klebsiella pneumoniae -staphylococcus warneri -enterobacter cloacae -klebsiella pneumoniae -enterococcus gallinarum -bacillus licheniformis -staphylococcus saprophyticus -microbacterium aurum -roseomonas mucosa -micrococcus luteus -staphylococcus capitis omsc surmised that this phenomenon was attributed to inappropriate reprocessing by the user.If significant additional information is received, this report will be supplemented.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The device was evaluated at olympus repair center.According to the evaluation, the following was found.There was a thin white coating on the metal ring around the electrical connector.Slight detachment of the bending section rubber glue.Minor damage of the bending section rubber glue.Reddish-brown residue in the groove next to the outlet of the biopsy channel.Whitish-gray residue in the gap at the distal end.White crystals on the underside of the forceps elevator.White crystals on the wall of the forceps elevator drive unit.White coating on the base under the forceps elevator.Around 3 cm down from the biopsy channel outlet in the distal end at the connection between the channel pipe and the resin channel, there was a brownish-yellow line.-beneath the arm cover, flecks of a brownish-red coating and/or discoloration.-white flakes inside the mount of the device.-combination of brownish-yellow coating/discoloration and damage was inspected inside the mount of the device.-white or reddish-brown coating and a small pool of fluid in the suction cylinder.-large quantity of fluid droplets over the entire length of the suction channel.-reddish-brown coating in the channel joint in the suction connector which was confirmed before.Olympus confirmed that there were multiple inappropriate procedures in the forceps elevator reprocessing procedure of the user facility.If significant additional information is received, this report will be supplemented.

Event Description

During an academic conference, the user presented a poster with the following information regarding these related records: patient identifier# (ercp): kind of bacteria: (b)(6), p2, (b)(6) 2020, (b)(6) 2020, rectal swabs, esbl-producing citrobacter freundii.(b)(6), p3¿, (b)(6) 2020, (b)(6) 2020, rectal swabs, esbl producing klebsiella pneumoniae.(b)(6), p1, (b)(6) 2020, (b)(6) 2020, blood, esbl-producing citrobacter freundii.(b)(6), p2, (b)(6) 2020, (b)(6) 2020, urine, esbl-producing citrobacter freundii.(b)(6), p3, (b)(6) 2020, (b)(6) 2020, blood, esbl-producing klebsiella pneumoniae.The five patients with possible cross-contamination were described above as p1, p2, p2', p3 and p3' on the poster.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information received.B5 has been updated.Although the complaint captured in related record (patient identifier # (b)(6) was initiated for the ¿p1¿ esbl-producing klebsiella pneumoniae (as documented on poster from academic conference),¿ the case was eliminated from the investigation for possible cross-contamination because the patient was already positive with esbl-producing klebsiella pneumoniae prior to this incident.Based on the additional information received, there are no changes to the legal manufacturer¿s investigation findings that was previously submitted.

Manufacturer Narrative

This report is being submitted to correct the legal manufacturer¿s contact information and facility registration number.The facility registration number is 9610595.

• 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: 10481088
• MDR Text Key: 206536551
• Report Number: 8010047-2020-06092
• Device Sequence Number: 1
• Product Code: FDT
• UDI-Device Identifier: 04953170367311
• UDI-Public: 04953170367311
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 05/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/02/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Model Number: TJF-Q180V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/08/2019
• 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