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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN SMALL INTESTINAL VIDEOSCOPE

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OLYMPUS MEDICAL SYSTEMS CORP. UNKNOWN SMALL INTESTINAL VIDEOSCOPE Back to Search Results
Model Number UNKNOWN
Device Problem Appropriate Term/Code Not Available (3191)
Patient Problem Not Applicable (3189)
Event Type  Injury  
Manufacturer Narrative
The subject device was not been returned to olympus medical systems corp (omsc). Omsc could not review the service and manufacturing record because the serial number was not provided from the facility. The malfunction of the subject device concerning this case has not been reported. The exact cause could not be determined.
 
Event Description
On may 11, 2018, olympus medical systems corp (omsc) received a literature titled ¿safety and efficacy of endoscopic bile duct stone treatment procedure for elderly people who experienced intestinal reconstructive surgery. ¿ that was made in public in the 95th congress of the japan gastroenterological endoscopy society on may 2018. The literature reported the result of 186 cases (285 procedures) of endoscopic bile duct stones treatment using single balloon endoscopy (sbe) for the elderly people between january 2007 and september 2017. In the subject procedures, accidental symptoms reportedly occurred as follows; pancreatitis occurred in 9 procedures; intestinal perforation occurred in 5 procedures; cholangitis occurred in 5 procedures; bleeding occurred in 3 procedures; leakage pancreatic juice occurred in 1 procedure; bile duct perforation occurred in 1 procedure. The literature concluded that, it was suggested that the procedure can be performed safety and effectively for even if the patient was elderly people (more than 75 years old) who experienced intestinal reconstructive surgery. Omsc reviewed the delivery history of the endoscopes (sbe type) and the history revealed that olympus small intestinal videoscopes (sif-y0004, sif-y0004-v01, sif-y0015, sif-h290s, sif-q260) had been delivered to the facility. Olympus is submitting mdr according to the number of procedural accidents case because it was not informed which endoscope model was used in the procedures. This is 23 of 24 reports.
 
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Brand NameUNKNOWN
Type of DeviceSMALL INTESTINAL 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 Key7577281
MDR Text Key110336817
Report Number8010047-2018-01061
Device Sequence Number1
Product Code FDA
Combination Product (y/n)N
Reporter Country CodeJA
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 06/07/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/07/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberUNKNOWN
Device Lot 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 Received05/11/2018
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 Treatment Data
Date Received: 06/07/2018 Patient Sequence Number: 1
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