MAUDE Adverse Event Report: OLYMPUS MEDOCAL SYSTEM CORPORATION OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE

Model Number TJF-Q180V

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Bacterial Infection (1735)

Event Date 01/27/2014

Event Type  Injury  

Event Description

Olympus was informed that twelve patients tested positive for escherichia coli (e coli) containing extended-spectrum beta lactamase (esbl) after having undergone an endoscopic retrograde cholangiopancreatography (ercp) procedure.The positive cultures were isolated from the patient's blood, pseudocyst, and bile.The patients were examined with four different duodenovideoscopes.These duodenovideoscopes were cultured twice by the user facility.No organisms were isolated.On (b)(6) 2014, the first patient underwent an ercp.After the procedure, the patient tested positive for resistant e coli.No additional information was available.

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.As part of our investigation with this report, olympus representatives visited the user facility to observe the user facility's reprocessing practices.There were minor deviations noted during the reprocessing of the device.It was noted that the user facility had no suction in the reprocessing room and the staff were not using a syringe to flush around the forceps elevator riser area.A supplemental report will be submitted if additional information becomes available later.Please cross-reference the following reports for the other eleven cases: 2951238-2014-00211, 00212, 00213, 00219, 00220, 00221, 00222, 00223, 00224, 00225 and 00226.

• Brand Name: OLYMPUS EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDOCAL SYSTEM CORPORATION; 2951 ishikawa-cho, hachioji-shi; tokyo ; JA
• Manufacturer (Section G): OLYMPUS MEDICAL SYSTEM CORPORATION; 2951 ishikawa-cho, hachioji-shi; tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 3850580
• MDR Text Key: 4656732
• Report Number: 2951238-2014-00174
• Device Sequence Number: 1
• Product Code: FDT
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/02/2014

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
• Device Catalogue Number: TJF-Q180V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/02/2014
• Initial Date FDA Received: 05/22/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Treatment: CUSTOM ULTRASONICS REPROCESSOR
• Patient Outcome(s): Other