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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

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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 Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/21/2022
Event Type  malfunction  
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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 Key14164481
Report Number8010047-2022-06736
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K950166
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,Health Professional,User Facility
Reporter Occupation
Type of Report Initial
Report Date 04/20/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/20/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0730
Device Lot Number1YV
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received03/24/2022
Was Device Evaluated by Manufacturer? No
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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