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

Model Number JF-260V

Device Problem Microbial Contamination of Device (2303)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2020

Event Type  malfunction  

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 as a result of routine microbiological testing by the user facility, the sample collected from the subject device tested positive for the unspecified microbes.The device had been reprocessed a non-olympus automated endoscope reprocessor, endoclens.There was no report of infection associated with this report.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.Olympus medical systems corp.(omsc) was informed that the microbes which had been found at the user facility microbiological test was escherichia coli.The subject device was returned to omsc for the evaluation and investigation.Omsc observed the subject device channel inside from the instrument channel outlet of the distal end to the suction connector.It was found no abnormality such as the kinks or damage except the white foreign objects.It also was not found the significant dirt, foreign objects, damage at the distal end or instrument channel port or around the suction cylinder and the air/water cylinder.Omsc reviewed the manufacturing history (dhr) of the subject device and confirmed no irregularity.As a result of analysis of the white foreign objects, it was the dry powder.Chlorine and sodium were detected strongly by the energy-dispersive x-ray spectroscopy analysis.Omsc surmised that the white foreign objects might be the sodium chloride which is derived from the physiological saline.Olympus service operation repair center (sorc) checked the subject device and found that following; the angulation had been insufficient.The coating of the suction cylinder and the air/water cylinder had peeled.The adhesive of the bending section rubber had been chipped.The insertion tube had scratches, dents and creases.The adhesive of the light guide lens had peeled.There was air leak from the elevator control lever and metal part of the distal end.According to the additional information from the user, the subject device had been reprocessed with a non-olympus automated endoscope reprocessor, endoclens neo, using phtharal.The exact cause of the reported event could not be conclusively determined at this time.

• Brand Name: EVIS LUCERA 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: 10904567
• MDR Text Key: 226353860
• Report Number: 8010047-2020-09458
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/12/2021

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
• Device Operator: Health Professional
• Device Model Number: JF-260V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 10/28/2020
• Initial Date FDA Received: 11/25/2020
• Supplement Dates Manufacturer Received: 12/16/2020
• Supplement Dates FDA Received: 01/12/2021
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 01/31/2008
• 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