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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED)

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OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE PRELOADED SPHINCTEROTOME V (DISTAL WIREGUIDED) Back to Search Results
Model Number KD-VC611Q-07201S
Device Problem Unexpected Therapeutic Results (1631)
Patient Problem Laceration(s) (1946)
Event Date 09/13/2018
Event Type  Injury  
Manufacturer Narrative
The device was not returned to olympus. The cause of the reported event could not be determined at time. In addition, insufficient information regarding the reported device, patient and procedure was reported. Olympus will continue to investigate this complaint to obtain more detailed information regarding the reported event. If additional information becomes available, this report will be updated and supplemented accordingly.
 
Event Description
Olympus was informed that during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the device did not bow at the tip but instead the catheter contorted at the handle. The patient was cut in the wrong area. No additional cut was performed the doctor was able to complete the procedure using the existing cut. The procedure was completed but not the way it was intended.
 
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Brand NameSINGLE USE PRELOADED 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
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key7980422
MDR Text Key124185160
Report Number2951238-2018-00625
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K141991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 01/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/18/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-VC611Q-07201S
Device Catalogue NumberKD-VC611Q-07201S
Device Lot Number83V
Was Device Available for Evaluation? No Answer Provided
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Event Location No Information
Date Manufacturer Received12/20/2018
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: 10/18/2018 Patient Sequence Number: 1
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