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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE
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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE Back to Search Results
Model Number CLV-190
Device Problem Use of Device Problem (1670)
Patient Problems Perforation (2001); Discomfort (2330); Abdominal Distention (2601)
Event Type  Injury  
Event Description
It is reported an unstated period of time following a colon screening procedure using a evis exera iii xenon light source, the patient developed abdominal distention and severe abdominal discomfort-worse on the right.A post-procedure perforation was discovered.The patient was taken for an emergent exploratory laparotomy with abdominal irrigation and right hemicolectomy.The patient recovered and was discharged from the hospital (b)(6) 2020.It is the provider's opinion that the olympus clv-190 could have potentially caused or contributed to the event as the airflow was set on high.
 
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Brand Name
EVIS EXERA III XENON LIGHT SOURCE
Type of Device
XENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
MDR Report Key10818016
MDR Text Key215579182
Report Number2951238-2020-00515
Device Sequence Number1
Product Code NWB
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other
Type of Report Initial
Report Date 10/29/2020,11/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/10/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberCLV-190
Was Device Available for Evaluation? No
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date10/29/2020
Event Location Hospital
Date Report to Manufacturer10/29/2020
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Hospitalization; Required Intervention;
Patient Age77 YR
Patient Weight79
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