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

Model Number KD-V411M-0725

Device Problem Break (1069)

Patient Problem Burn(s) (1757)

Event Date 03/13/2017

Event Type  Injury  

Manufacturer Narrative

The subject product was returned to omsc for investigation.The investigation confirmed that the cutting wire was broken.The broken section was melted and burned.As a measurement result of the outer diameter of the knife wire, there was no abnormality.The device history record for the lot indicated no anomaly with the event-related items below.Dc resistance value of the knife wire.Operation of the knife wire.This type of damage is most likely related to the operator¿s technique.As the results of the investigation, omsc assumes that the damage of the coating and cutting wire occurred due to contacting with the metal part of the forceps elevator of the endoscope.The coating of the cutting wire was likely caught and tore by the forceps elevator of the endoscope.The exposed cutting wire contacted or came close to the metal part of the forceps elevator while activating the output, and it caused spark and a part of the cutting wire became extremely hot, resulting in breakage.It is considered that when the knife wire was broken, the knife wire, which was heated, contacted to the papilla, causing the burn.The device instruction manual has 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.

Event Description

Olympus medical systems corp (omsc) was informed that during ercp, the knife wire was broken after activation.The broken knife wire came in contact with the papilla of the 11 o'clock direction and burn occurred at the contact area.There was no bleeding at the burn site and no additional treatment was done.The procedure was completed with a spare device of the same model.

• 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 ; 8142642517
• MDR Report Key: 6480003
• MDR Text Key: 72355357
• Report Number: 8010047-2017-00422
• 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: foreign,user facility
• Reporter Occupation: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: KD-V411M-0725
• Device Lot Number: K7209
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/22/2017
• Date Manufacturer Received: 03/16/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/09/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other