MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number KD-V451M

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/10/2016

Event Type  malfunction  

Manufacturer Narrative

The device referenced in this report has not yet been returned to olympus for evaluation.The manufacturing history of the subject device was reviewed, with no irregularities noted.Therefore the exact cause of the reported event could not be conclusively determined at this time.Additionally this instrument has been designed to be used with an olympus endoscope and electrosurgical unit for papillotomy.If additional information or the device is received a later time, this report will be supplemented.

Event Description

At the time of dissection of tracheal stricture, the cutting knife of the subject device broke in the patient, and it remained on the tissue of the strictured part.The physicians were able to retrieve the remained cutting knife together with the tissue of the stricture of the patient.The procedure was completed with another similar device.There was no patient injury, but the surgical time was prolonged.

Manufacturer Narrative

As an investigation result of the complaint device, it was found that the cutting wire broke as pointed out and the broken part was burnt and melted.When the cutting wire was withdrawn from the sheath, it was found that the wire coating was split.A part of the wire coating was missing and the length of the left part was 2.5mm shorter than the specification.The outer diameter of the cutting wire was normal.The edge surface of the distal end of the sheath was burnt and melted.The model of the complaint device was found kd-v451m, not kd-v441m.The lot # is k6915.There were no abnormalities in the following items in the manufacturing history of the same lot of kd-v451m, which are relating to the pointed phenomenon.Outer view of the cutting wire.Movement of the cutting wire.Outer view of the wire coating.Length of the wire coating.Dc resistance value of the cutting wire.As a result of investigation on the complaint device and the findings that the length of the cutting wire is normal and the length of the wire coating was 2.5mm shorter than the specification, the fragment which fell off upon retrieval of the cutting wire is presumed to be a part of the wire coating.It is presumed that the cutting wire broke due to the sequential causes as follows.The wire coating was split and the cutting wire was exposed.Output was activated while the exposed cutting wire (only cutting wire part) was put in point contact or close with/ to the distal metal part of the endoscope.An electrical discharge occurred and the cutting wire was instantaneously heated to a high temperature.As a result, the cutting wire ended up in breakage.The splitting of the wire coating is presumed to be caused by a load applied to the wire coating, such as getting caught at the clearance between the forceps elevator and the forceps elevator housing at the distal end of endoscope.The following details are found in the instruction manual.When using the kd-v451m, do not forcefully contact the coated portion of the cutting knife.Doing so could damage the coated portion of the cutting knife.Instrument damage malfunction can result.When using the kd-v451m, and any irregularity is detected on the coated surface of the cutting knife, immediately stop using it.Otherwise, patient injury such as perforation, bleeding, and mucous membrane damage could occur.If the electrosurgical unit is used in certain conditions such as in the coagulation mode, when high-frequency output is set too high, when the activation time is too long, or when the length of the contact between the cutting knife and tissue is too short, deformation or breakage of the cutting knife can occur.When applying the current, do not use the instrument in the ¿coagulation¿ mode.During treatment, always ensure that the operation felt at hand and the cutting knife observed in the endoscopic image are normal.Should a deformation or breakage of the cutting knife be detected during use, immediately shut off the power supply, discontinue the procedure, pull the slider to retract the cutting knife into the tube, or, if the cutting knife is not retractable, pull the slider and fix it to ensure the cutting knife does not move, then withdraw the instrument from the endoscope.To prevent perforation or bleeding, do not use an abnormal instrument.If the cutting knife is dropped, be sure to collect it using grasping forceps.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Type of Device: SINGLE USE 3-LUMEN NEEDLE KNIFE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to
• Manufacturer Contact: hiroki moriyama ; 2951 ishikawa-cho; hachioji-shi, tokyo-to ; 8142642517
• MDR Report Key: 6146956
• MDR Text Key: 61863376
• Report Number: 8010047-2016-10091
• Device Sequence Number: 1
• Product Code: KNS
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK955247
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-V451M
• Device Lot Number: K6915
• Other Device ID Number: 04953170382703
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/16/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/10/2016
• Initial Date FDA Received: 12/06/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/06/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/15/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1