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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-0720
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/09/2022
Event Type  malfunction  
Event Description
An olympus territory manager, who was present in the endoscopic room with the physician, reported the blade broke off in the distal part of the subject device, near the insulation, during an endoscopic retrograde cholangiopancreatography procedure (ercp). The blade broke while making the third cut. The procedure was completed with another device of the same model. There was a delay in the procedure to change out the device; however, there was no impact on the patient. There was no harm or user injury reported due to the event.
 
Manufacturer Narrative
The suspect device was returned to olympus for evaluation. Inspection and testing are not yet complete. The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time. However, if additional information becomes available, this report will be supplemented accordingly.
 
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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 Key13725198
MDR Text Key296974358
Report Number8010047-2022-04258
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,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/30/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/10/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0720
Device Lot Number1ZV
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/25/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/01/2021
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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