MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. OLYMPUS ENDOSCOPIC CO2 REGULATION UNIT

Model Number UCR

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem Bowel Perforation (2668)

Event Date 06/10/2015

Event Type  Injury  

Manufacturer Narrative

The referenced ucr is not return to olympus medical systems corp.(omsc) for evaluation, therefore omsc cannot evaluate the ucr yet.The exact cause of the reported event could not be conclusively determined at this time.However it is generally known that the perforation during endoscopy is attributed to handling by physician and/or patient's condition.According to the literature, it is known that perforation may cause as a consequent of pneumoderma and/or gas embolism, and so on.Olympus stated that when ucr supplies co2, users must stop device like light source from supplying air in the instruction manual of ucr.There were no further details provided.If significant additional information is received, this report will be supplemented.This report is being submitted as a medical device report in an abundance of caution.Please cross reference 8010047-2015-00761.

Event Description

During the colonoscopy with the ucr and the cf-h190l, the patient's sigmoid was perforated.The patient had the diverticular disease as previous disease.The patient was treated for the perforation with 2 clips.After the procedure the pneumoderma occurred on the patient's face.The facility scanned the patient and found the air behind the eyes.The patient was admitted to the icu and stayed for two days, and then the patient was moved to the ward for one week.Then the patient was discharged.The air behind the eyes dissipated gradually in three weeks.The facility staff stated that during the procedure both the air (maybe by light source) and co2 by ucr were supplied to the patient.The setting level for both the air and co2 was unknown.

• Brand Name: OLYMPUS ENDOSCOPIC CO2 REGULATION UNIT
• Type of Device: CO2 REGULATION UNIT
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8 507; JA 192-8507
• Manufacturer Contact: susumu nishina ; 2951; ishikawa-cho; hachioji-shi, tokyo 192-8-507 ; JA 192-8507 ; 26425177
• MDR Report Key: 5020440
• MDR Text Key: 23660090
• Report Number: 8010047-2015-00760
• Device Sequence Number: 1
• Product Code: HIF
• Combination Product (y/n): N
• Reporter Country Code: AS
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Reporter Occupation: Other
• Report Date: 07/24/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: UCR
• Device Catalogue Number: UCR
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/21/2015
• Was Device Evaluated by Manufacturer?: No
• 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
• Treatment: CF-H190L
• Patient Outcome(s): Hospitalization