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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BALLOON DILATOR V (WITH KNIFE)

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE BALLOON DILATOR V (WITH KNIFE) Back to Search Results
Model Number BD-VC431Q-1840-20
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Death (1802); Perforation (2001); Blood Loss (2597)
Event Type  Death  
Manufacturer Narrative
The subject device was not returned to omsc (olympus medical systems corp. ) for evaluation since it was discarded by the user facility. We assumed the subject lot from the delivery date since the lot was unclear. The manufacturing history record of the lot was reviewed, with no irregularities noted. The doctor said that the incision direction of papilla was improper and it was not due to the device problems. Therefore, the improper incision by user handling caused this event. The instruction manual of the device has already warned as follows; do not insert the instrument into the endoscope unless you have a clear endoscopic field of view. If you cannot see the distal end of the insertion portion in the endoscopic field of view or in x-ray images, do not use it. This could cause patient injury, such as perforations, bleeding, or mucous membrane damage. It may also damage the endoscope and/or instrument.
 
Event Description
During endoscopic sphincterotomy (est), the doctor abandoned the procedure due to perforation and loss of blood from the patient¿s papilla. However, the details of the treatment for perforation and bleeding were unspecified, but it was reported that a metallic stent was inserted into papilla to press injury part. The patient was hospitalized.
 
Manufacturer Narrative
This supplemental report is being submitted to provide additional information from the user facility. Omsc was reported that the patient in this report died in the middle of (b)(6). We attempted to get more information, but it was not provided from the user facility.
 
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Brand NameSINGLE USE BALLOON DILATOR V (WITH KNIFE)
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
katsuaki morita
2951 ishikawa-cho
hachioji-shi, tokyo-to 
426425177
MDR Report Key6772971
MDR Text Key82006631
Report Number8010047-2017-01178
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PK150142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type health professional,user faci
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/04/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/07/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberBD-VC431Q-1840-20
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/18/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/07/2017 Patient Sequence Number: 1
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