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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 02/01/2022
Event Type  malfunction  
Manufacturer Narrative
The device kd-v411m-0320 was returned for evaluation. The lot number was 1xk with supplementary information number of ¿01¿. (m-bc manufacture date: october 1, 2021) device evaluation, the following were noted: the cutting wire was broken. 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. Gk6224, revision no. 8) contains the following information. Therefore, it would be possible to prevent this event from occurring. 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. 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. Do not activate output while the cutting wire touches the metal parts of the endoscope, or they are being close together. This could burn the tissue and/or damage the endoscope or the instrument. Investigation is ongoing. This report will be supplemented accordingly following investigation completion.
 
Event Description
It was reported that the knife broke during an est (endoscopic sphincterotomy) procedure. It is unknown whether or not it involves energization. The device was replaced with similar device and the intended procedure was completed. 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 the coated portion of the cutting wire was torn, and the broken portion was scorched and melted (knife wire breakage when energized) found during device return evaluation.
 
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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 Key13781446
MDR Text Key287274755
Report Number8010047-2022-04502
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
Reporter Occupation Non-Healthcare 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 Received03/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberKD-V411M-0320
Device Lot Number1XK
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/13/2022
Was the Report Sent to FDA? No
Date Manufacturer Received06/07/2022
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2021
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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