MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number KD-645L

Device Problems Break (1069); Device Fell (4014)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/08/2021

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

As reported during a poem (peroral endoscopic myotomy) therapeutic procedure, the distal tip of the knife broke.The distal tip (triangle-shaped) broke off, leaving a fragment inside the patient.The fragment was able to be removed by the user.A forceps or baskets were believed to be used to remove the fragments.The procedure was prolonged with unknown time however, the intended procedure was completed using another device of the same model.There was no patient injury or harm reported due to the event.No user injury reported.The product was used in combination with an olympus gastroscope (the model and serial number not provided) and with an esg-300 electrosurgical generator (serial number not provided), the reported event's cause was not attributed to these two devices.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customers contact name and job tittle.

Manufacturer Narrative

This report is being supplemented to provide a correction for g2, device evaluation and additional information based on the legal manufacturer's final investigation.G2 - checked 'other' to add country spain.The suspect device has been returned to olympus for evaluation.Device evaluation found the foreign substances had adhered around the distal end.A part of the cutting knife was damaged.The subject device was disassembled to confirm the surface of the damaged cutting knife.The surface was melted.No other abnormalities were confirmed at the insertion portion.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, a likely cause of the damage of the cutting knife might be the following: 1) during tissue incision, an electrical discharge might have occurred due to one of the following factors: the setting of the electrosurgical unit was coagulation mode when the device was used for the procedure.The activation time was too long.2) an electrical discharge occurred, and the part of the cutting wire became hot instantly.As a result, the strength of the cutting knife decreased.3) during tissue incision, a load was applied to the cutting knife which has the reduced strength.This might have caused the cutting knife to break.The specific root cause of could not be determined at this time.The following information is stated in the instructions for use: "during treatment, always ensure that the slider slides on the handle smoothly and that the electrosurgical knife observed in the endoscopic image is normal.Should deformation or break of the cutting knife and the triangle tip be detected during use, immediately shut off the power supply, discontinue the procedure, pull the slider and, withdraw the endoscope from the patient with the cutting knife retreated in the coated outer tube.Do not continue using an abnormal electrosurgical knife to prevent perforation or bleeding.If the cutting knife and/or the triangle tip is detached, be sure to collect it using a grasping force.Do not set the output value of the electrosurgical unit too high or too low.Also, do not allow the activation time to be too long or too short.Set the high-frequency output mode of the electrosurgical unit optimally according to the conditions of the tissue to be cut.An excessive or insufficient output value may result in perforation, bleeding, tissue damage, or thermal injuries to the non-target tissue.Always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.An excessive output level and time may result in patient injury, such as perforation, bleeding, or mucous membrane damage.Application of high-voltage waveforms for extended periods increases the likelihood that the cutting knife and the triangle tip may break.When a high-voltage waveform has to be used, minimize the duration of current application." olympus will continue to monitor field performance for this device.

Manufacturer Narrative

Please see update in h6 ¿ type of complaint.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• Type of Device: SINGLE USE ELECTROSURGICAL KNIFE
• 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 Key: 12555658
• MDR Text Key: 274066304
• Report Number: 8010047-2021-12515
• Device Sequence Number: 1
• Product Code: KNS
• UDI-Device Identifier: 04953170407857
• UDI-Public: 04953170407857
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K182408
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 06/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: KD-645L
• Device Lot Number: 0YK
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/18/2020
• 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
• Treatment: GASTROSCOPEESG 300 GENERATOR; GASTROSCOPEESG 300 GENERATOR