• Decrease font size
  • Return font size to normal
  • Increase font size
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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V SINGLE USE 2-LUMEN SPHINCTEROTOME Back to Search Results
Model Number KD-V411M-0730
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Hemorrhage/Bleeding (1888); Pancreatitis (4481)
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
On may 10, 2021, olympus medical systems corp. (omsc) received the literature titled "endoclip therapy of post-sphincterotomy bleeding using a transparent cap-fitted forward-viewing gastroscope". This study was conducted on endoscopic retrograde cholangiopancreatography(ercp) with endoscopic sphincterotomy(es) for 1448 patients from january 2011 to december 2015. In the literature, it was reported 57 patients of uncontrolled hemorrhage, and 3 patients of mild pancreatitis. The 57 patients of uncontrolled hemorrhage were 45 patients of early uncontrolled hemorrhage and 12 patients of delayed hemorrhage. All 57 patients with post-es uncontrolled hemorrhage underwent endoclip therapy, and hemostasis was successfully achieved in all patients with early uncontrolled or delayed hemorrhage. However, five patients with delayed hemorrhage required blood transfusions after ercp to remove stones, and one of five patients with severe bleeding received a total of six units of packed red blood cells. Three patients with difficult cannulation developed mild pancreatitis after the procedure and fully recovered with conservative management. Therefore, omsc assumes that the five patients with delayed hemorrhage required blood transfusions was an adverse event to submit due to required blood transfusions. 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. Omsc will submit one medical device reports (mdr) of the subject device for five patients with delayed hemorrhage required blood transfusions.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key11861688
MDR Text Key262885764
Report Number8010047-2021-06589
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeKS
PMA/PMN Number
K950166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,literature
Reporter Occupation
Type of Report Initial
Report Date 05/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model NumberKD-V411M-0730
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 Received05/10/2021
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

Patient Treatment Data
Date Received: 05/21/2021 Patient Sequence Number: 1
-
-