MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN SPHINCTEROTOME V; SINGLE USE 2-LUMEN SPHINCTEROTOME

Model Number KD-V411M-0720

Device Problem Break (1069)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 11/15/2017

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus medical system corp.(omsc) for investigation.As a result of the investigation on (b)(6) 2017, it was confirmed that the cutting wire of the subject device was broken.The broken section of the cutting wire was melted and burned.The coating of the broken section was torn.Additionally, the coating on the cutting wire was missing about 5.0 mm to the specification.As a measurement result of the outer diameter of the cutting wire, there was no abnormality.The device history record for the lot indicated no abnormality with the event-related items below.Length of the coating on the cutting wire.Appearance of the coating on the cutting wire.Operation of cutting wire.Overall appearance.This type of damage is most likely related to the operator¿s technique.Based on the past similar cases, omsc assumes that the damage of the coating occurred due to contacting with the metal part of the forceps elevator of the endoscope.The exposed cutting wire from the damaged coating contacted or came close to the metal part of the forceps elevator while the device activated output, and it caused spark.Then, a part of the cutting wire became extremely hot, resulting in breakage.Omsc assumed that the missing of the coating occurred because the coating near the broken part of the cutting wire was subjected to a load during user handling, but the cause could not be conclusively determined.The instruction manual of the device has already warned as follows; 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.

Event Description

During an endoscopic sphincterotomy, the subject device was used.It was reported that the cutting wire of the subject device was broken.There was no patient injury reported.The subject device was returned to olympus medical system corp.(omsc) for investigation.As a result of the investigation on (b)(6) 2017, it was confirmed that the cutting wire of the subject device was broken.Additionally, the coating on the cutting wire was missing about 5.0mm to the specification.

• Brand Name: SINGLE USE 3-LUMEN SPHINCTEROTOME V
• Type of Device: SINGLE 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: katsuaki morita ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 7124570
• MDR Text Key: 95771933
• Report Number: 8010047-2017-02002
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: PK950166
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/18/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KD-V411M-0720
• Device Lot Number: 79K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/22/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/24/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/22/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1