MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORPORATION EVIS EXERA II DUODENOVIDEOSCOPE; DUODENOENDOSCOPE

Model Number TJF-Q180V

Device Problems Device Reprocessing Problem (1091); Device Disinfection Or Sterilization Issue (2909)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Event Description

Olympus medical sys corp (omsc) was informed that citrobacter and moraxella were detected during a routine inspection.No pt infection was reported.

Manufacturer Narrative

The device has not been returned to olympus for evaluation.The tech visited the user facility on (b)(4) 2014 and checked that the reprocessing procedure was not according to the manual.For example, biopsy channel was not brushed, suction port was not brushed, manual cleaning was performed in water only (no detergent), biopsy port was not brushed properly, wiping the surface of the endoscope was not performed with lint-free cloth, elevator area was brushed only with a toothbrush.On 30 january 2015, a technician checked with a person of the facility reprocessing one of the tjf-q180v's, which the user facility possesses and found that the procedure was not according to the manual.Channels were not filled with detergent before brushing.Very old, cold and dirty water used for manual cleaning.The hospital used are reused, and broken maj-1888 to brush the elevator area.Maj-1888 should be single use device.Elevator area was not brushed sufficiently.Improper flushing of the elevator area was confirmed.All findings of the improper cleaning and disinfection have been communicated to the hosp on the following day.The mfg history was reviewed, but with no irregularities related to this problem noted.Olympus concluded that this event was caused due to improper reprocessing.Please cross reference these associated complaints: 8010047-2014-00154 and 8010047-2014-00155.

• Brand Name: EVIS EXERA II DUODENOVIDEOSCOPE
• Type of Device: DUODENOENDOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORPORATION; 2951 ishikawa-cho; hachioji-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951 ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 4706912
• MDR Text Key: 17626659
• Report Number: 8010047-2015-00328
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2015
• Is this an Adverse Event Report?: No
• 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
• Date Manufacturer Received: 04/15/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 06/01/2012
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other