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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 Problems Device Reprocessing Problem; Device-Device Incompatibility
Event Type  Malfunction  
Manufacturer Narrative

The scope has not returned to olympus for evaluation. The cause of the reported complaint cannot be confirmed. As a preventive measure against retained objects in the channel, the scope instructions manual has pre-procedure inspection instructions which include passing a test device down the instrument channel regardless of the procedure type: ¿insert the endotherapy accessory through the biopsy valve. Confirm that the endotherapy accessory extends smoothly from the distal end. Also make sure that no foreign objects come out of the distal end. ¿ the instructions manual also warns that during use, ¿avoid aspirating solid matter or thick fluids; instrument channel, suction channel, or suction valve clogging can occur. ¿ the scope reprocessing manual also states, ¿all channels of the endoscope, including the instrument channel and the auxiliary water channel, and all accessories used with the endoscope during the patient procedure, such as all valves and the auxiliary water tube (maj-855), must be cleaned and high-level disinfected or sterilized after each patient procedure, even if the channels or accessories were not used during the patient procedure. ¿ the reprocessing instructions also include several flushes of the instrument channel. As part of our investigation, an endotherapy support specialist will be dispatched to observe the facility¿s reprocessing practice and provide additional retraining as necessary. When additional information arrives regarding the event or the impact of the event, this report will be updated accordingly.

 
Event Description

Olympus was informed that a blood clot and unspecified model clip were retained in the scope biopsy / instrument channel following a gi bleed procedure involving the use of cook hemospray for hemostasis. The procedure also involved suction. After the procedure, the scope was reprocessed and next used in a bariatric procedure with the clot and clip still inside undetected. The bariatric procedure did not involve use of the instrument channel. During manual cleaning following the bariatric procedure, the channel was flushed and the clot and clip were dislodged from the scope. There was no reported patient injury or infection from the event. After the event, cook advised olympus that the use of hemospray with suction is not recommended.

 
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Brand NameEVIS EXERA II GASTROINTESTINAL VIDEOSCOPE
Type of DeviceGASTROINTESTINAL VIDEOSCOPE
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8 507
JA  192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose , CA 95131
4089355124
MDR Report Key8229785
Report Number2951238-2019-00337
Device Sequence Number1
Product CodeFDF
Report Source Manufacturer
Reporter Occupation OTHER HEALTH CARE PROFESSIONAL
Report Date 07/30/2019
2 DeviceS WERE Involved in the Event: 1   2  
0 PatientS WERE Involved in the Event:
Date FDA Received01/08/2019
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
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
Event Location No Information
Date Manufacturer Received01/25/2019
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

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