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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 Unclear Information (4052)
Patient Problem Injury (2348)
Event Type  Injury  
Manufacturer Narrative
Insufficient information was provided by the user facility. Multiple follow ups were made to obtain additional information from the user facility via telephone and in writing but no information has been obtained. The reported device will not be returned as the user facility discarded the device following the procedure. The exact cause of the reported event cannot be confirmed. If additional information becomes available, this report will be supplemented accordingly.
 
Event Description
Olympus was informed that during a therapeutic procedure, the device reportedly had an unspecified failure and caused patient injury.
 
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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 192-8 507
JA 192-8507
Manufacturer Contact
connie tubera
2400 ringwood avenue
san jose, CA 95131
4089355124
MDR Report Key8234406
MDR Text Key132641039
Report Number2951238-2019-00350
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K141991
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial
Report Date 01/09/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/10/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-VC611Q-07201S
Device Lot NumberUNKNOWN
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 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: 01/10/2019 Patient Sequence Number: 1
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