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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME Back to Search Results
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Hemorrhage/Bleeding (1888)
Event Type  Injury  
Manufacturer Narrative
The subject device was not returned to olympus medical systems corp. (omsc) for evaluation. Therefore, the exact cause of the reported event could not be conclusively determined. Since the serial number is unknown, the device history record could not be reviewed. However, omsc has only shipped devices that passed the inspection. In the literature, there is no description of the device's malfunction.
 
Event Description
Olympus medical systems corp. (omsc) received a literature titled "evaluation of the safety and efficacy of minimal endoscopic sphincterotomy followed by papillary balloon dilation for the removal of common bile duct stones". The literature reported the result of 435 patients with common bile duct (cbd) stones who underwent endoscopic sphincterotomy procedure using the olympus clever cut 3v and non-olympus device from january 2009 to december 2018. In the literature, it was reported complication as follows: post-ercp pancreatitis (9 cases); early bleeding (12 cases): these patients with early bleeding required unplanned hospital admission or prolongation of hospital stay; delayed bleeding (3 cases); perforation (3 cases); acute cholangitis (4 cases); acute cholecystitis (4 cases); and recurrence of cbd stones (32 cases). There are not mentioned that these complications were related to the subject device in question. However, omsc assumes that "early bleeding" and "perforation" might be related to "clever cut 3v" due to the procedure using "clever cut 3v". Omsc assumes that the "early bleeding" was serious injury due to required unplanned hospital admission or prolongation of hospital stay. And, there is no detailed description of the "perforation". However, omsc assumes that "perforation" was might be caused or contributed to a death or serious injury. Based on the available information, specific information on the subject device and the patients were not provided. There is no description of the device's malfunction. Therefore, omsc assumes that the "early bleeding" and "perforation" were adverse events to submit. Omsc will submit two medical device reports (mdrs) of the subject device for the "early bleeding" and "perforation". This report is for "early bleeding".
 
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Brand NameSINGLE USE 3-LUMEN SPHINCTEROTOME V
Type of DeviceSINGLE USE 2-LUMEN SPHINCTEROTOME
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 Key12251129
MDR Text Key268358567
Report Number8010047-2021-09550
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
K950166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
Type of Report Initial
Report Date 07/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/30/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
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 Received07/05/2021
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: 07/30/2021 Patient Sequence Number: 1
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