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

Model Number TJF-145

Device Problem Microbial Contamination of Device (2303)

Patient Problems Fever (1858); Unspecified Infection (1930)

Event Date 06/11/2020

Event Type  Injury  

Manufacturer Narrative

The subject 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, following microbes were detected from the sample collected from the subject device.Instrument/suction channel: stenotrophomonas maltophilia (>20 cfu/ml), auxiliary water channel: stenotrophomonas maltophilia (>20 cfu/ml).The exact cause of the reported event could not be conclusively determined.If additional information becomes available, this report will be supplemented.

Event Description

Olympus medical systems corp.(omsc) was informed that the user facility performed the endoscopic removal of stones from biliary tract on a patient using the subject device on (b)(6) 2020, and that the patient developed fever on that night.The user facility performed blood cultures testing on the patient and found that the patient was positive for hafnia alvei and staphylococcus epidermidis.The patient's infection was resolved during hospitalization and the patient had no particular problems currently.The device was not used for other procedures after using to the patient.There were no cases of infection in other patients.The user facility did not perform microbiological testing on the subject device.The subject device had been reprocessed with an olympus automated endoscope reprocessor model mini etd2 (not available in the usa), using peracetic acid.After the patient's infection for two kind of bacteria, the facility reprocessed the subject device with an olympus automated endoscope reprocessor model etd3 basic (not available in the usa), using peracetic acid.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.The distal end unit of the subject device was returned to olympus medical systems corp.(omsc) for evaluation.Omsc checked the subject device and found following.Remained protein, which indicates insufficient reprocessing, was not confirmed.Confirmed trace of crevice corrosion of stainless steel, occurred by water invaded for a long time period, at the gap generated from glue being peeled off, and at s-cylinder where to attach button.Omsc reviewed the manufacture history (dhr) of the subject device and confirmed no irregularity.The exact cause of the reported phenomenon could not be conclusively determined.For the patient infection, since the bacteria confirmed from the patient were not detected from the scope, it is presumed that the patient infection was caused by other than the scope.For the positive culture test, corrosion marks in which water was present for a long time on the adhesive peeling part was confirmed on the device.It is presumed that the gram-negative bacteria detected from the scope may have occurred because the adhesive peeling part became difficult part to reprocess.

• 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: 10429390
• MDR Text Key: 211946179
• Report Number: 8010047-2020-05626
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• PMA/PMN Number: K954451
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/20/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: TJF-145
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/13/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other