MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-645

Model Number	KD-645L
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/14/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The suspect device has been returned to olympus for evaluation.The visual inspection for the as received condition identified biomaterial inside the distal end indicating use.The handle could be operated smoothly and was able to extend/retract the knife.The cutting knife length measured about 4.5mm which met specification; however, its triangle tip melted off and missing.Observed that no damage on the working portion, coil sheath, and distal end cover are intact.There is a continuity between the cutting knife and the plug contact pin.Also, when using the test a cord jack mh-969 inserted into the plug and confirmed that it clicked into place.Based on the evaluation findings, the reported complaint was confirmed.The damage on the knife distal tip is likely due to thermal load applied and the knife was melted.Once the investigation has been completed, a supplemental report will be submitted with device evaluation results.This report has been submitted by the importer under this mdr report number 2429304 - 2023 - 00066.
Event or Problem Description
The customer reported during a therapeutic peroral endoscopic myotomy for type ii achalasia, the subject device tip "fell off" during the procedure.There was no melting identified.The customer reported they were unable to locate the tip of the knife.The customer did not report if additional intervention was attempted, including diagnostic testing to locate the device.There was a forty (40) minute procedural delay and the procedure was completed with another device.The subject device was inspected prior to use and was determined to be in "excellent condition." due to the lack of information provided by the customer and the potential for the device tip to be unknowingly left in the patient, this will be reported as a serious injury.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.It has been less than 1 year since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be determined, the subject device¿s tip falling off was likely due to 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.Also, the cutting wire was scorched.3) during tissue incision, a load was applied to the cutting knife which has reduced strength.This might have caused the cutting knife to break and fall off.Furthermore, since the broken device tip could not be located inside the patient, the root cause could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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 forceps.¿ ¿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.¿ ¿electrosurgical unit: voltage intensities of various waveforms: soft coagulation < cut / pulse cut < forced coagulation < spray coagulation¿.¿do not activate output continuously but activate it intermittently.Continuous activation may result in patient injury, such as bleeding, tissue damage, or thermal injury of non-target tissue.Breakage or deformation of the triangle tip and cutting knife may likely occur.¿ ¿stop activating output immediately if the triangle tip and the cutting knife are found to turn red while activating output.Keeping output activated while the triangle tip and the cutting knife are red may result in thermal injury.Detachment of the triangle tip and deformation/break of the triangle tip and cutting knife may also occur.¿ this supplemental report includes information added to d8 and h4.Olympus will continue to monitor field performance for this device.
Additional Manufacturer Narrative
This supplemental report includes a correction to h6.Code corrected from "44" to "4307".

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-645
• Common Device Name: SINGLE USE ELECTROSURGICAL KNIFE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 16736519
• Report Number: 9614641-2023-00520
• Device Sequence Number: 20499014
• Product Code: KNS
• UDI-Device Identifier: 04953170407857
• UDI-Public: 04953170407857
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: K182408
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/05/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: KD-645L
• Device Lot Number: 2ZK 05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/05/2023
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2023
• Supplement Date Received by Manufacturer: 05/29/2023; 06/28/2024
• Initial Report FDA Received Date: 04/13/2023
• Supplement Report FDA Received Date: 06/05/2023; 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/04/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NON-OLYMPUS GENERATOR
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown