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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 Problem Break (1069)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/17/2022
Event Type  malfunction  
Event Description
As reported, during the ercp (endoscopic retrograde cholangiopancreatography) procedure , knife of subject device broke inside patient but was retrieved. No injury reported. The intended procedure was completed with another device and there were no more than fifteen (15) minutes delay in the procedure. There was no patient harm or injury reported due to the event. No user injury reported. The customer returned 4 devices with the same failure description and the event date are the same for the 4 devices that reported to fail during the procedure. The lot number are the same for the 4 returned devices. This report is related to reports with patient identifier: (b)(6).
 
Manufacturer Narrative
Initial reporter name and address: the full address name of the facility is (b)(6). Communication with the customer , the following information was provided: the knife broke when press the foot switch of the electrosurgical unit to activate output and perform the incision. Setting value for the cut mode : auto cut 35w, coagulation 40w broken knife wire broke did not fall into patient body. Reported event occurred about 30 minutes after the procedure started. Reporter stated seeing from the scope the wire was contacting the tissue directly. The subject device was received and evaluated. Device inspection and evaluation, the following information noted : the lot number was 19k with supplementary information number of ¿27¿. (m-bc manufacture date: (b)(6)2021. Device evaluation noted the knife wire found fused at the junction of the insulation coating part and the effective cutting part. 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. Instruction for use (ifu) : this instruction manual contains the following information. (drawing no. Gk6226 revision no. 13). 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. Be sure that the rear end of the cutting wire is extended from the distal end of the endoscope. In case the cutting wire contacts the forceps elevator, insufficient output or unintended tissue injury may occur. 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. 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. 1. The device was not protruded enough from the endoscope until the rear end of the cutting wire was in the field of view. 2. Due to the situation of ¿1¿ description, the cutting wire and the endoscope were being close to each other. 3. The output was activated in state of ¿2¿ description. This might have led to an electrical discharge between the cutting wire and the distal end of the endoscope. 4. An electrical discharge possibly occurred, and the cutting wire became hot instantly. That might have caused the cutting wire to break. Olympus will continue to monitor complaints 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 Key14683295
MDR Text Key303177151
Report Number8010047-2022-09976
Device Sequence Number1
Product Code KNS
UDI-Device Identifier04953170184031
UDI-Public04953170184031
Combination Product (y/n)N
Reporter Country CodeCH
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 06/14/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/14/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0725
Device Lot Number19K
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/20/2022
Was the Report Sent to FDA? No
Date Manufacturer Received05/17/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured09/27/2021
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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