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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-0725
Device Problems Break (1069); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 02/14/2022
Event Type  malfunction  
Manufacturer Narrative
The suspect device was returned to olympus for evaluation. During inspection, the cutting (knife) wire was confirmed to be broken and the broken portion was scorched and melted. When the outer diameter of the cutting wire was measured, there was no abnormality identified. It was also confirmed that there was no problem with the length of the cutting wire and and the length of the coated portion of the cutting wire. It was also confirmed that there were no missing parts in the subject device. There were no defects identified with the device that could have caused the breakage of the cutting wire. A review of the device history record found no deviations that could have caused or contributed to the reported issue. The device met all specifications at the time of shipment. Based on the results of the legal manufacturer's investigation, although a definitive root cause could not be identified, it is likely the issue was due to the output being activated while a torn area of the coated portion of the cutting wire came into contact with the distal end of the endoscope while the forceps elevator was raised, causing the cutting wire to become instantly hot, resulting in the wire breaking. Based on the results of the legal manufacturer's investigation, it is likely the coated portion was torn due to the forceps elevator being raised. Then, when the cutting wire deflected, the coated portion of the cutting wire and the metal part of the distal end of the endoscope came into contact. The cutting wire moved back and forth, causing the coated portion of the cutting wire to tear. The slider was pushed more than needed, causing the cutting wire to deflect. The device's instruction manual provides the following warnings which may help to prevent the issue: "since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the cutting wire is very short, the output is too high or activated while the cutting wire touches metal parts of the endoscope, or the cutting wire is tightened too strong. When the cutting wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled. If the slider is pushed, the cutting wire will be pushed out toward the papilla or move sideways. If the cutting wire breaks off, stop the output immediately and pull the slider completely to retract the broken cutting wire into the tube. Then withdraw the sphincterotome from the papilla. Otherwise, patient injury, such as perforations, bleeding, or lacerations within the biliary duct, and/or damage of the endoscope could result". "when inserting the instrument into the endoscope, be sure that the cutting wire is parallel to the tube. Otherwise, the metal part of the forceps elevator may contact the cutting wire and peel off the coating material". "do not activate output while tissue is in contact with the torn or damaged coated portion of the distal end. If output is activated while tissue is contacting the torn or damaged coated portion due to insertion into or withdrawal from an endoscope, leakage current, decreased output, and/or thermal injury could result". "if you feel the cutting is blunt, withdraw the device from the scope to examine if there is any peel off and tear at the coating portion". Olympus will continue to monitor field performance for this device.
 
Event Description
The customer reported the knife wire on the sphincterotome broke while making an incision, when the device was energized during an endoscopic sphincterotomy procedure. The intended procedure was completed with another device of the same model. There was no patient/user harm or injury reported due to the event.
 
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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 Key13773375
MDR Text Key294118208
Report Number8010047-2022-04467
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,Company Representative
Reporter Occupation
Type of Report Initial
Report Date 03/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0725
Device Lot Number1XK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/27/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received02/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/25/2021
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: 03/15/2022 Patient Sequence Number: 1
Treatment
TJF-Q290V: DUODENOVIDEOSCOPE; VIO100: ERBE ELECTROSURGICAL UNIT
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