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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-0330
Device Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/28/2022
Event Type  malfunction  
Manufacturer Narrative
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.
 
Event Description
The customer reported that while preparing the subject device for an unspecified procedure, the knife wire broke but it was not energized and had not fallen off. Another device of the same model was used to complete the intended procedure. There was no patient or user injury reported due to the event. The device was returned to an olympus service center for evaluation. Upon inspection and testing of the returned device, it was observed that the broken part of the knife wire was burnt and it appeared that it had been broken by energization. This report is being submitted for the malfunction found during evaluation (the knife wire was burnt and broken by energization). Additional details have been requested regarding the reported event. At this time, no additional information has been provided.
 
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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 Key14063079
MDR Text Key298520271
Report Number8010047-2022-06015
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,User Facility,Company Representative
Reporter Occupation Non-Healthcare Professional
Type of Report Initial,Followup
Report Date 07/01/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/08/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0330
Device Lot Number17K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/08/2022
Was the Report Sent to FDA? No
Date Manufacturer Received06/03/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/19/2021
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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