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 10/03/2016

Event Type  Injury  

Manufacturer Narrative

The subject device has not been returned to olympus medical systems corp.(omsc) for evaluation.Omsc reviewed the manufacture history of the subject device and confirmed no irregularity.The exact cause could not be determined at present, if significant additional information is received, this report will be supplemented.

Event Description

Olympus was informed that after an ercp procedure for stone extraction, a patient sample tested positive for an undetermined bacteria.The user facility quarantined the subject device and reviewed the history of the medical use of the subject device at the user facility.The review found that after the latest repair (field corrective action replacement and normal repair) by olympus in (b)(6) 2016, the subject device had been used for 2 or 3 patients.The positive patient sample was reported on the patient examined with this scope after this repair.Then, the facility conducted additional microbiological testing for the subject device.In the testing, the subject device did not grow any microorganisms.There was no infection report of the other patients.

• 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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6245000
• MDR Text Key: 64577254
• Report Number: 8010047-2017-00024
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: PK143153
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial

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: 04953170229503
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/16/2016
• Initial Date FDA Received: 01/12/2017
• 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
• Patient Outcome(s): Other