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

Model Number CF-H180AL

Device Problem Maintenance Does Not Comply To Manufacturers Recommendations (2974)

Patient Problem Bowel Perforation (2668)

Event Date 01/22/2015

Event Type  Injury  

Event Description

Olympus was informed that two patients sustained colon perforation during a diagnostic colonoscopy procedure.It was reported that both patients were examined with the same colonoscope.Both patients were transferred to operating room for surgical intervention.Both patients are reportedly doing fine.This is one of two reports.

Manufacturer Narrative

The device was returned to olympus for evaluation.The evaluation revealed that there was evidence of third-party repairs on the device, as the entire insertion tube, and light guide tube were non-olympus parts.There was no sharp edges or surfaces that would likely cause or contribute to the patients' outcome.Based on the investigation, the most likely cause of the reported event is attributed to user handling.Additionally, the instructions for use states: "prohibition of improper repair and modification.This instrument does not contain any user-serviceable parts.Do not disassemble, modify or attempt to repair it; patient or operator injury and/or equipment damage may result." cross reference manufacturer report number: 2951238-2015-00021.

• Brand Name: OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE
• Type of Device: ENDOSCOPIC VIDEO IMAGING SYSTEM
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 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: 4502020
• MDR Text Key: 16069027
• Report Number: 2951238-2015-00020
• 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: Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/06/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CF-H180AL
• Device Catalogue Number: CF-H180AL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 01/28/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention
• Patient Age: 73 YR