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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 UNKNOWN
Device Problem Insufficient Information (3190)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp (omsc). The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined. If additional information becomes available, this report will be supplemented.
 
Event Description
Olympus medical systems corp. (omsc) received a literature titled ¿long-term outcomes of endoscopic papillary large-balloon dilation for common bile duct stones¿. The literature reported the result of 98 cases of the endoscopic papillary large balloon dilation (eplbd) procedure for patients with common bile duct stones (cbd) using olympus videoscope model jf-260v or tjf-260v or gif-xk240 or sif-q260 and 5. 5-fr cannula and stonemaster v from october 2011 to december 2015. In the subject cases, 1 case of perforation, 3 cases of acute cholangitis and 5 cases of acute cholecystitis occurred. Perforation occurred in the procedure using gif-xk240 or sif-q260. Based on the available information, a direct relationship between the olympus products and the observed adverse events could not be determined. Therefore, omsc will submit 6 medical device reports (mdr) depending on the type of device and type of adverse events. This report is 5 of 6 reports for acute cholangitis at stonemaster v.
 
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Brand NameSINGLE USE BALLOON DILATOR V (WITH KNIFE)
Type of DeviceBALLOON DILATOR
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 Key10031881
MDR Text Key190106900
Report Number8010047-2020-02536
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K150142
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature,user facility
Reporter Occupation
Type of Report Initial
Report Date 05/07/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/07/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional?
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/09/2020
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

Patient Treatment Data
Date Received: 05/07/2020 Patient Sequence Number: 1
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