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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE
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SHIRAKAWA OLYMPUS CO., LTD. EVIS EXERA III XENON LIGHT SOURCE Back to Search Results
Model Number CLV-190
Device Problem Use of Device Problem (1670)
Patient Problem Perforation of Esophagus (2399)
Event Date 08/10/2023
Event Type  Injury  
Event Description
The customer reported to olympus the evis exera iii xenon light source was used during a therapeutic endoscopic ultrasound and endoscopic retrograde cholangiopancreatography (for an unspecified indication) in conjunction with another insufflator when a perforation was noted in the patient¿s esophagus.The user was unaware both devices introduced air into the patient¿s system.As a result, the patient was hospitalized for a few days for monitoring and reported in good condition.No additional surgical or medical interventions were required.
 
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Brand Name
EVIS EXERA III XENON LIGHT SOURCE
Type of Device
XENON LIGHT SOURCE
Manufacturer (Section D)
SHIRAKAWA OLYMPUS CO., LTD.
3-1 okamiyama
odakura, nishigo-mura
nishishirakawa-gun, fukushima 961-8 061
JA  961-8061
MDR Report Key17777000
MDR Text Key323766699
Report Number2429304-2023-00296
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 Distributor
Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date 08/24/2023,09/19/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/19/2023
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 Date08/24/2023
Event Location Hospital
Date Report to Manufacturer08/24/2023
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
NON-OLYMPUS INSUFFLATOR.
Patient Outcome(s) Hospitalization;
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