• 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 SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED 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 SPHINCTEROTOME V (DISTAL WIREGUIDED) SINGLE USE PRELOADED SPHINCTEROTOME Back to Search Results
Model Number KD-VC631Q-07301S
Device Problem Break (1069)
Patient Problem Blood Loss (2597)
Event Date 02/07/2019
Event Type  Injury  
Manufacturer Narrative
The subject device referenced in this report has not yet been returned to olympus for evaluation. Therefore the exact cause of the reported event could not be conclusively determined at this time. A supplemental report will be submitted, if additional or significant information becomes available at a later time.
 
Event Description
During a sphincterotomy, the subject device was used. In the procedure, the cutting wire of the subject device broke. Bleeding occurred because of the broken wire. The physician used a balloon to stop the bleeding. This is the report regarding the occurrence of bleeding.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSINGLE USE SPHINCTEROTOME V (DISTAL WIREGUIDED)
Type of DeviceSINGLE USE PRELOADED SPHINCTEROTOME
Manufacturer (Section D)
OLYMPUS MEDICAL SYSTEMS CORP.
2951 ishikawa-cho
hachioji-shi, tokyo-to
Manufacturer Contact
kazutaka matsumoto
2951 ishikawa-cho
hachioji-shi, tokyo-to 192-8-507
JA   192-8507
426425177
MDR Report Key8392810
MDR Text Key137931779
Report Number8010047-2019-01190
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeFR
PMA/PMN Number
K141991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 04/26/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/05/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-VC631Q-07301S
Device Lot Number88V
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received04/08/2019
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: 03/05/2019 Patient Sequence Number: 1
-
-