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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-2TH180
Device Problem Break (1069)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 07/14/2017
Event Type  malfunction  
Manufacturer Narrative
The scope and the biopsy cap were returned to olympus for evaluation.The evaluation confirmed the reported event.A visual inspection found the rubber cap damaged.In addition, the scope¿s biopsy channel was found leaking.There was a tear mark found inside the biopsy channel wall that likely contributed to the leak.The light guide lens was also found cracked.The scope was serviced and returned to the user facility.Based on the evaluation findings, the cause of the damaged biopsy cap is likely due to user handling / excessive force when inserting an accessory instrument through the biopsy cap.The instruction manual for use provides warning statements in an effort to prevent damage to the biopsy cap.¿slowly insert or withdraw the endotherapy accessory straight into or from the slit of the biopsy valve.Otherwise, the biopsy valve may be damaged and pieces of it could fall off.Inserting or withdrawing endotherapy accessories with excessive force may damage the instrument channel or endotherapy accessories and could cause some parts to fall off and/or cause patient injury.¿.
 
Event Description
Olympus was informed that towards the end of an upper endoscopy procedure, a small device fragment (biopsy cap) was found inside the patient¿s stomach.The device fragment was retrieved from the patient.The procedure was completed using the same scope.No patient injury reported.
 
Manufacturer Narrative
This supplemental report is being submitted to make a correction on the procode from fdf to fds.
 
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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
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
408935-512
MDR Report Key6762183
MDR Text Key81809860
Report Number2951238-2017-00507
Device Sequence Number1
Product Code FDS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK051645
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 03/01/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberGIF-2TH180
Device Catalogue NumberGIF-2TH180
Device Lot NumberN/A
Other Device ID Number04953170339752
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/19/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 07/14/2017
Initial Date FDA Received08/02/2017
Supplement Dates Manufacturer Received02/13/2019
Supplement Dates FDA Received03/02/2019
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? No
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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