MAUDE Adverse Event Report: OLYMPUS AMERICA, INC. EVIS EXERA II COLONOVIDEOSCOPE; COLONOSCOPE

Model Number CF-H180A1

Device Problems Break (1069); Material Fragmentation (1261)

Patient Problem Hemorrhage/Bleeding (1888)

Event Date 02/04/2015

Event Type  Injury  

Event Description

Olympus was informed that during a routine colonoscopy, the scope would not advance inside the patient's colon.The scope was withdrawn and it was reported that the bending section rubber had come off inside the patient's colon.The device fragment was retrieved, but the patient sustained an injury and bleeding were observed in the colon.The bleeding was rectified by applying cautery and the intended procedure was completed with the same device.The customer will send the referenced device to a third-party vendor for service.The device has been serviced by a third-party vendor several times.Olympus followed up with the user facility via telephone and in writing to obtain additional information regarding the reported event, but with no results.

Manufacturer Narrative

The device referenced in this report has not been returned to olympus for evaluation.The exact cause of the patient's outcome could not be conclusively determined at this time.If additional information becomes available at a later time, this report will be supplemented.

• Brand Name: EVIS EXERA II COLONOVIDEOSCOPE
• Type of Device: COLONOSCOPE
• Manufacturer (Section D): OLYMPUS AMERICA, INC.; 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: 4562273
• MDR Text Key: 18547008
• Report Number: 2951238-2015-00103
• Device Sequence Number: 1
• Product Code: NWB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K100584
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 02/05/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/27/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: CF-H180A1
• Device Catalogue Number: CF-H180A1
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 02/05/2015
• 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
• Patient Outcome(s): Other