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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS AMERICA, INC ENDOSCOPE REPROCESSOR
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OLYMPUS AMERICA, INC ENDOSCOPE REPROCESSOR Back to Search Results
Model Number OER-ELITE
Device Problems Fluid/Blood Leak (1250); Fumes or Vapors (2529)
Patient Problems Eye Burn (2523); Chemical Exposure (2570)
Event Date 07/05/2022
Event Type  Injury  
Event Description
The customer informed olympus, the physician and operator had extensive burning to their eyes after trying to load acecide-c bottles into the subject device.The bottles would not fit and when closing the drawer, the bottles leaked and caused excessive fumes.The physician was informed by olympus to remove eye contact lenses and flush with copious amounts of water.A request for additional information is in progress.This event includes 2 reports as follows: (b)(6) is for the physician exposed to the chemicals, with burning eyes.(b)(6) is for the operator exposed to the chemicals, with burning eyes.This is report 1 of 2 for (b)(6) is for the physician exposed to the chemicals, with burning eyes.
 
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Brand Name
ENDOSCOPE REPROCESSOR
Type of Device
ENDOSCOPE REPROCESSOR
Manufacturer (Section D)
OLYMPUS AMERICA, INC
3500 corporate parkway
center valley PA 18034 0610
MDR Report Key15163207
MDR Text Key297225620
Report Number2429304-2022-00014
Device Sequence Number1
Product Code FEB
UDI-Device Identifier04953170404047
UDI-Public04953170404047
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Physician
Type of Report Initial
Report Date 07/05/2022,08/04/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/04/2022
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberOER-ELITE
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Distributor Facility Aware Date07/05/2022
Event Location Hospital
Date Report to Manufacturer07/05/2022
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
ACECIDE-C
Patient Outcome(s) Other;
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