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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 Type  malfunction  
Event Description
It was reported that during a therapeutic procedure, the knife wire broke while it was being used. It was energized several times however, it is unknown whether it was a ruptured accompanied by energization. The intended procedure was completed with similar device. There was no patient harm or injury reported due to the event. No user injury reported. Device evaluation found the coated portion of the cutting wire was torn, and the broken portion was scorched and melted. This report is being submitted for cutting wire broken portion was scorched and melted found during device evaluation.
 
Manufacturer Narrative
The device kd-v411m-0725 was returned for evaluation. The lot number was 1xk with supplementary information number of ¿08¿. (m-bc manufacture date: october 8, 2021) device evaluation, the following were noted: 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. The dhrs (device history records) for this product have been reviewed. No abnormalities were detected in the device history record with the lot number for the following inspection items which related to the reported phenomenon. Length of cutting wire. Length of coated portion. Operation of cutting wire. The instruction manual (drawing no. (b)(4), revision no. 8) contains the following information. Since the cutting wire is very thin, it may break off in the following cases: the distance between the papilla of vater and the wire is very short, the output is too high or activated while the wire touches metal parts of the endoscope, or the wire is tightened too strong. When the wire breaks off, its proximal end will be retracted toward the endoscope if the slider is pulled. If the slider is pushed, the wire will be pushed out toward the papilla or move sideways. If the wire breaks off, stop the output immediately and pull the slider completely to retract the broken wire into the tube. Then withdraw the instrument 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. 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. Based on the results of confirmation of the device and the investigation results in the past, a likely mechanism causing the broken cutting wire might be the following: 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. The output was activated, the cutting wire coated portion came into contact with the distal end of the endoscope while the forceps elevator was raised, 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 result 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. The coated portion of the cutting wire and the metal part of the distal end of the endoscope come into contact, 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. Investigation ongoing. This report will be supplemented accordingly following completion of investigation.
 
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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 Key13746086
MDR Text Key296494341
Report Number8010047-2022-04351
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/05/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/12/2022
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 Manufacturer02/13/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/07/2021
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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