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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-0320
Device Problems Break (1069); Melted (1385)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/07/2022
Event Type  malfunction  
Event Description
The customer reported that during a therapeutic endoscopic sphincterotomy (est) procedure with endoscopic retrograde cholangiopancreatography (erco), the knife wire broke the second time it was energized. The broken knife wire did not detach from the device. Another similar device was used to complete the intended procedure. There was no report of patient or user injury due to the event.
 
Manufacturer Narrative
The subject device was returned to olympus for evaluation. Upon inspection and testing of the device, it was confirmed that the cutting wire (knife wire) was broken. The coated portion of the cutting wire was torn, and the broken portion was scorched and melted. The outer diameter of the cutting wire was measured and no abnormalities were identified. The length of the coated portion of the cutting wire, and the cutting wire itself, presented no abnormalities. There were no missing parts in the subject device. The distal end of the tube was deformed. A pre-curved form of the tube was looser than usual. Since the cutting wire was broken, the direction of the cutting wire could not be confirmed while inserting the device into the endoscope. 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, it is likely the coated portion of the cutting wire was torn while the forceps elevator of the endoscope was raised, the slider was pushed more than needed, causing the cutting wire to deflect. When the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope came into contact. Then, the cutting wire was moved back and forth, causing the coated portion of the cutting wire to tear. The cutting wire at the torn area of the coated portion then came into contact with the distal end of the endoscope while the forceps elevator was raised. The output was then activated, causing the cutting wire to become instantly hot, resulting in breakage of the cutting wire. However, a definitive root cause of the reported issue could not be determined. Regarding the distal end of the tube being deformed, the shape of the distal end of the product undergoes 100% inspection. Therefore, it is possible that a force was applied to the distal end of the product during device handling as described below, which may have caused the tube to deform. ·when pre-curved stylet was removed. ·when an attempt was made to curve the distal end of the tube. ·when the device was inserted into the endoscope. ·when an attempt was made to extend the distal end of the tube while the forceps elevator was raised. ·when the guide wire was inserted into the distal end of the tube, if the guide wire was used for the procedure. The instructions for use provides the following information regarding the reported event: "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. Do not use excessive force to bend the distal end of the instrument. This could damage the cutting wire and/or the instrument. When inserting the instrument into the endoscope, hold the slider firmly. Otherwise, the distal end of the insertion portion may angle and extend from the distal end of the endoscope abruptly. This could cause patient injury, such as perforation, bleeding or mucous membrane damage. It may also damage the endoscope and/or instrument. When inserting the instrument into the endoscope, hold the slider firmly. Otherwise, the distal end of the insertion portion may angle and extend from the distal end of the endoscope abruptly. This could cause patient injury, such as perforation, bleeding or mucous membrane damage. It may also damage the endoscope and/or instrument. Do not force the instrument if resistance to insertion is encountered. Reduce the angulation or lower the forceps elevator until the instrument passes smoothly. This could cause patient injury, such as perforation, bleeding or mucous membrane damage. It could also damage the endoscope and/or instrument. Do not advance or extend the instrument abruptly. This could cause patient injury, such as perforation, bleeding or mucous membrane damage. It could also damage the endoscope and/or instrument. When inserting the instrument into the endoscope, hold it close to the biopsy valve and keep it as straight as possible relative to the biopsy valve. Otherwise, the insertion portion could be damaged. Insert the instrument slowly. Abrupt insertion could damage the endoscope and/or instrument. " olympus will continue to monitor field performance for this device.
 
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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 Key14018340
MDR Text Key295045018
Report Number8010047-2022-05762
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,Followup
Report Date 08/01/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/05/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0320
Device Lot Number1ZK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received07/29/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured12/10/2021
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: 04/05/2022 Patient Sequence Number: 1
Treatment
OLYMPUS JF-260V EVIS LUCERA DUODENOVIDEOSCOPE
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