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

Model Number TJF-Q180V

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Unspecified Infection (1930)

Event Date 09/01/2017

Event Type  Injury  

Manufacturer Narrative

The forceps elevator was replaced according to an olympus field corrective action on (b)(6) 2016.The subject device has not been returned to olympus medical systems corp.But was returned to olympus (b)(4).Following additional high level disinfection at (b)(4), the subject device was sent to a third party laboratory for additional microbiological testing.In the test, the test result indicated no microbial growth for the subject device.After the additional microbiological testing, (b)(4) continued with the incoming inspection in the repair center.During incoming inspection the endoscope passed the leakage test successfully and olympus performed a technical evaluation.Olympus found signs of wear and tear at the distal end of the subject device as there were slight angle-rubber damages and cementing deterioration that were classified as "minor" repairs.The exact cause could not be determined at present.Olympus is planning to follow up with the facility to obtain additional information.If significant additional information is received, this report will be supplemented.

Event Description

Olympus (b)(4) was informed that two patients tested (b)(6) for (b)(6) on (b)(6) 2017 after having undergone endoscopic retrograde cholangiography (ercp) using the subject device.One of the two patients reportedly had fever after the ercp.It was reported that the test result of the microbiological testing for the subject device at the facility did not reveal the bacteria.The subject device had been reprocessed using non-olympus automated endoscope reprocessor (soluscope 4) with peracetic acid.This is two of two reports.

Manufacturer Narrative

This supplemental report is being submitted to provide additional information.On october 19, 2017, olympus (b)(4) received an incident report from (b)(4) authority and was informed about additional 2 cases of infection ( total 4 cases of patient ¿infections and/or colonization of high resistant bacteria¿ ) at the facility.The incident report also reported that the subject device was returned from repair on july 20, 2017.This is two of four reports.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 426425177
• MDR Report Key: 6982699
• MDR Text Key: 90395585
• Report Number: 8010047-2017-01564
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date: 11/14/2017

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
• Other Device ID Number: 04953170339967
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/27/2017
• Supplement Dates Manufacturer Received: 10/19/2017
• Supplement Dates FDA Received: 11/14/2017
• Was Device Evaluated by Manufacturer?: No
• 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