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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 04/04/2022
Event Type  malfunction  
Manufacturer Narrative
The device was evaluated, and the reported issue was confirmed. The knife wire was broken. The broken part was burnt black and melted. The investigation is ongoing. A supplemental report will be submitted upon completion of the investigation.
 
Event Description
It was reported by the customer, the wire broke on the single use 3-lumen sphincterotome v while operating the steering wheel and outputting high frequency several times by lightly stepping on the foot switch. The sphincterotome was not energized by hitting something. The issue was found during preparation for use for a therapeutic endoscopic retrograde cholangiopancreatography (ercp) procedure. There was no impact on the procedure. The intended procedure was completed with another device. No patient harm reported.
 
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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 Key14250443
MDR Text Key290531774
Report Number8010047-2022-07305
Device Sequence Number1
Product Code KNS
Combination Product (y/n)N
Reporter Country CodeJA
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 04/29/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/29/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0730
Device Lot Number21K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/07/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received04/04/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/14/2022
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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