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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE Back to Search Results
Model Number GIF-H180
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Death (1802)
Event Date 10/16/2019
Event Type  Death  
Manufacturer Narrative
The scope was not returned for evaluation.The gi manager provided information regarding the reprocessing.Pre-cleaning is being performed immediately after a procedure as per manufacturer's pre-cleaning instructions.The scope is being brushed during manual cleaning.The scope is being leak tested.The effective concentration is being checked between each scope reprocessing.There are no issues with the aer.Flushing (air) into the channel of the scope is done after reprocessing.There have been no changes to the reprocessing personnel.The scope has been removed from service.A review of the service history indicated the scope was purchased on june 13, 2012 with six repairs in the past three years; no repairs involving cross contamination issues and four repairs related to leaks in the scope.As part of the investigation, an olympus endoscopy support specialist (ess) was requested to be dispatched to the user facility to observe the facility¿s reprocessing practice and to provide a reprocessing training.To date, the ess visit has not been finalized.The exact cause of the reported event cannot be determined.However, if additional information becomes available, this report will be updated accordingly.This reported event has been reported by the importer on mdr# 2951238-2019-01197.
 
Event Description
The manufacturer was informed that a patient reportedly expired and that the patient had creutzfeldt-jakob disease (cjd).The gi manager at the user facility further reported the scope had been used on other patients (not specified) but no other patient infections were reported from the use of this scope.The doctor performed a small bowel endoscopy with biopsy for mild esophagitis procedure on (b)(6) 2019.The patient's positive culture was detected on (b)(6) 2019.There was no scope malfunction reported.The scope was used with cold forceps.The scope was not cultured or sterilized since the date of the event.The scope was taken out of service at notification of patient's diagnosis, after being manual cleaned and high level disinfected.
 
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Brand Name
EVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
Type of Device
GASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key9375270
MDR Text Key167980592
Report Number8010047-2019-04083
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K100584
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial
Report Date 11/26/2019
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 NumberGIF-H180
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 10/31/2019
Initial Date FDA Received11/26/2019
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 Reuse
Patient Sequence Number1
Treatment
AER:(2)CUSTOM ULTRASONICB00100, B00103; AER:CUSTOM ULTRASONIC SN (B)(4); AER:CUSTOM ULTRASONIC SN (B)(4); CLEANING DETERGENT: INTERCEPT; DISINFECTANT SOLUTION- MEDLINE OPA; LEAK TESTER: MEDIVATORS VERISCAN; SINGLE USE/DUAL END VALVE CHANNEL BRUSH:GI SOURCE.
Patient Outcome(s) Death;
Patient Age53 YR
Patient Weight112
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