• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA III XENON LIGHT SOURCE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

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 Problem Perforation (2001)
Event Date 09/26/2018
Event Type  Injury  
Manufacturer Narrative
The device was not returned to olympus for evaluation. The exact cause of the reported event could not be determined at this time. In addition, insufficient information regarding the reported device, patient and procedure was reported. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event. If additional information becomes available, this report will be updated and supplemented accordingly. However, based on the reported information the operator¿s technique cannot be ruled out as a contributory factor. The olympus sales representative reported that the most probable cause of the reported event could be attributed to both the ucr and clv-190 air supply being on at the same time. The instruction manual for the ucr warns, ¿during use, always stop the device like light source from supplying air. If stop is not selected, a mixture of air and co2 may be supplied into the patient body. ¿ in addition, the instruction manual for the clv-190 (section 5. 9) also provides warning that states, ¿over-insufflating the lumen may cause patient pain, injury, bleeding, gas embolism, and/or perforation. ¿.
 
Event Description
Olympus was informed that during a pneumoperitineum procedure, the patient¿s cecum was perforated. The patient was given versed and sentinol for sedation and the procedure lasted 30 minutes. The air from the light source (clv-190) and co2 from the regulation unit (ucr) were used simultaneously during the procedure as the physician switched back and forth between air and co2. The physician noted that both the air and co2 were on at the same time. A few hours after the procedure was completed, while the patient was in recovery, the patient experienced abdominal pain. It was determined that the patient needed a surgical procedure to treat a cecal perforation. 2 of 2 devices.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameEVIS EXERA III XENON LIGHT SOURCE
Type of DeviceXENON LIGHT SOURCE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key7970381
MDR Text Key123867064
Report Number2951238-2018-00623
Device Sequence Number1
Product Code GCT
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131780
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/08/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/16/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberCLV-190
Device Catalogue NumberCLV-190
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received02/20/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 10/16/2018 Patient Sequence Number: 1
Treatment
COLONOSCOPE: OLYMPUS CF-HQ190L, SERIAL: UNKNOWN; REGULATION UNIT: OLYMPUS UCR, SERIAL: UNKNOWN; TUBING FOR UCR: MEDIVATOR MODEL/SERIAL: UNKNOWN
-
-