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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 05/13/2022
Event Type  malfunction  
Manufacturer Narrative
The device is returned and an evaluation completed for it. The user¿s complaint was confirmed. Device history record review indicates that the device was manufactured and tested in accordance with all applicable procedures and met all final product release criteria. Upon inspection and testing of the device, it was observed that the cutting 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. The result indicated no abnormalities. 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. Other abnormalities that could lead to the breakage of the cutting wire were not confirmed. Additional information was not available from the customer. Based on the confirmation result and the investigation results in the past, a likely mechanism causing the broken cutting wire might be as below. However, the exact cause of the problem could not be conclusively identified. (1) the cutting wire at a torn area of the coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised. (2) the output was then activated, and the cutting wire became hot instantly. This caused the cutting wire to break. It has been confirmed that the tear of the coated portion of the cutting wire could duplicate by the following mechanism. (1) the forceps elevator of the endoscope was raised. (2) when the cutting wire deflects, the coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact. (3) then the cutting wire was moved back and forth. This caused the coated portion of the cutting wire to tear. The slider was pushed more than needed. This caused the cutting wire to deflect. Avoiding the above situations will prevent the cutting wire from breaking. The instructions for use includes the following statements: 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.
 
Event Description
As reported for this event by the customer, at the end of a therapeutic endoscopic sphincterotomy (est) the device knife wire broke when the power was turned on. The procedure was completed at the time of the device breakage. There is no harm or adverse impact to the patient. The functional mode at the time of the breakage was effect 2, endocut 2, incision time: 2. Incision interval: 4.
 
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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 Key14651259
MDR Text Key301928314
Report Number8010047-2022-09789
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170382628
UDI-Public04953170382628
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,Followup
Report Date 07/12/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/09/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0720
Device Lot Number22K 04
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/24/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/14/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured02/03/2022
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: 06/09/2022 Patient Sequence Number: 1
Treatment
VIO300D ELECTROSURGICAL UNIT.
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