MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEM CORP OLYMPUS; EVIS EXERA II COLONOVIDEOSCOPE

Model Number CF-H180AI

Device Problem Increase in Pressure (1491)

Patient Problem Blood Loss (2597)

Event Date 06/26/2014

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to aizu olympus for evaluation.As a result of evaluation, it was confirmed that the auxiliary channel had an obstructed part inside which was caused by adhesive seepage.After removing the adhesive seepage, it was confirmed that flushing from the auxiliary channel became softer than before removing.As a result of reviewing the repair history of the subject device, it was confirmed that the all channel and c-cover was replaced in the subject device on (b)(6) 2014.As stated above, the reported phenomenon is likely caused by the adhesive which seeped out inside the auxiliary channel during the repair.

Event Description

Olympus medical systems corp.(omsc) performed a mdr retrospective review and found that this report was required.Olympus was informed that flushing from the auxiliary water channel of the subject device was stronger than other endoscopes, and it caused minor bleeding on the intestinal mucosa of the patient.The facility determined that no treatment for the bleeding was required.The facility noticed the bleeding and aborted the use of flushing from the auxiliary channel.The procedure was completed with the subject device.

• Brand Name: OLYMPUS
• Type of Device: EVIS EXERA II COLONOVIDEOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 2951; ishikawa; hachiouji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachiouji-chi, tokyo 192-8-507 ; JA 192-8507
• MDR Report Key: 6278799
• MDR Text Key: 65777671
• Report Number: 8010047-2017-10056
• Device Sequence Number: 1
• Product Code: FDF
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 01/26/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/26/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H180AI
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/19/2009
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1