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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
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AOMORI OLYMPUS CO., LTD. SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED) Back to Search Results
Model Number KD-VC611Q-07301S
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2024
Event Type  malfunction  
Event Description
It was reported the single use preloaded spincterotome experienced the cutting wire was broken.The issue occurred during a therapeutic sphincterotomy procedure.There were no reports of patient harm.
 
Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
SINGLE USE PRELOADED SPHINCTEROTOME V(DISTAL WIREGUIDED)
Type of Device
SINGLE USE PRELOADED SPHINCTEROTOME
Manufacturer (Section D)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA  036-0357
Manufacturer (Section G)
AOMORI OLYMPUS CO., LTD.
2-248-1 okkonoki
kuroishi-shi, aomori 036-0 357
JA   036-0357
Manufacturer Contact
todd brill
800 west park drive
westborough, MA 01581
5082077661
MDR Report Key19216044
MDR Text Key341502676
Report Number9614641-2024-01015
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 Foreign,Health Professional,User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 04/30/2024
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberKD-VC611Q-07301S
Device Lot Number35V
Was Device Available for Evaluation? Yes
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 04/04/2024
Initial Date FDA Received04/30/2024
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 Sequence Number1
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