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 Device Handling Problem (3265)

Patient Problem No Code Available (3191)

Event Date 03/03/2017

Event Type  Injury  

Manufacturer Narrative

The subject product was returned to omsc for investigation.The investigation confirmed that the device could be turned on without problems.As a measurement result of the resistance value between the knife wire and the plug of the operation part, there was no anomaly.The knife wire was burned.The device history record for the lot indicated no anomaly with the event-related items below.Dc resistance value of the knife wire.The exact cause could not be determined.Based on the past similar cases, following possibility is considered as the cause that the device could not be turned on.Foreign materials adhered to the knife wire.The target site was immersed in liquid.Bodily fluids and tissues burned due to factors such as output for an extended period and the scorch stuck to the knife wire.The device instruction manual has warned the users follows.1) before use, prepare and inspect the instrument and a cord as instructed below.Should any irregularity be observed, do not use the instrument or a cord; use a spare instead.Damage or irregularity may compromise patient or user safety, pose an infection control risk, cause tissue irritation, perforations, bleeding, mucous membrane damage, thermal injury and may result in more severe equipment damage.

Event Description

Olympus medical systems corp (omsc) was informed that, the physician tried to open the papilla with the device during ercp, but could not turn on the power.The physician canceled the procedure because the physician could not turn on the power even if replaced with another device and peripheral equipment.At a later date, the procedure was completed with still another device of same model.Two mdr's are submitted for incidents involving two devices on the single patient.This report describes the second of the two devices.

• 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: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 8142642517
• MDR Report Key: 6441915
• MDR Text Key: 71093282
• Report Number: 8010047-2017-00366
• 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: Other
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: No Information
• Device Model Number: KD-V411M-0725
• Device Lot Number: K6511
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/13/2017
• Date Manufacturer Received: 03/03/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization
• Patient Age: 92 YR