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

Model Number CF-Q180AL

Device Problems Contamination (1120); Contamination /Decontamination Problem (2895)

Patient Problem Chemical Exposure (2570)

Event Date 09/12/2014

Event Type  Injury  

Event Description

Olympus was informed that three patient's reportedly developed chemical colitis after being examined with a colonoscope.The patient first patient has undergone a diagnostic colonoscopy procedure on (b)(6) 2014.The patient returned to the emergency room the following day due to abdominal pain, and the patient was diagnosed with chemical colitis.The patient was provided antibiotics and the patient is reportedly doing fine.This is one of three reports.

Manufacturer Narrative

The colonoscope was returned to olympus for evaluation.The instrument channels of the colonoscope were examined using a borescope, and there was evidence of orange residue noted in the biopsy channel mount, which is located in the control body unit.The orange residue is indicative of inadequate reprocessing of the colonoscope.The colonoscope passed the leak test.The colonoscope was serviced and returned ot the user facility.As part of our investigation to this report an endoscope support specialist was dispatched to the user facility to assess their reprocessing practices, and to provide reprocessing training if necessary.If additional and significant info is received at a later time, this report will be supplemented.Cross reference report numbers: 2951238-2014-00431, and 2951238-2014-00480.

• Brand Name: OLYMPUS EVIS EXERA II COLONOVIDEOSCOPE
• Type of Device: COLONOSCOPE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEM CORP; 2951 ishikawa-cho; hachiomi-shi, tokyo 192- 8507; JA 192-8507
• Manufacturer Contact: noemi schambach ; 2400 ringwood ave.; san jose, CA 95131 ; 4089355002
• MDR Report Key: 4188794
• MDR Text Key: 16088533
• Report Number: 2951238-2014-00430
• 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: 09/30/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: CF-Q180AL
• Device Catalogue Number: CF-Q180AL
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/01/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/30/2014
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 38 YR