MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL KNIFE KD-655

Model Number	KD-655U
Medical Device Problem Code	Dull, Blunt (2407)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/06/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
The customer reported to olympus that the electrosurgical knife was unable to cut properly and difficulty with injection was observed during a submucosal dissection.A similar device was used as replacement, but the same issues were observed.Consequently, a fragmented mucosectomy had to be performed instead.As a result, the patient required a colonoscopy in 3 to 6 months instead of 3 to 6 years.There was no further harm or user injury reported due to the event.Case with patient identifier (b)(6) reports the initial electrosurgical knife.Case with patient identifier (b)(6) reports the replacement electrosurgical knife.
Additional Manufacturer Narrative
The device has not been returned to olympus and the definitive cause of the user's experience cannot be determined at this time.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation or when additional information becomes available.
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.Based on the results of the investigation, the high frequency knife stopping energizing was likely caused by the following: 1.The contact area between the cutting knife and target tissue was large which decreased the high frequency current density.2.Adhesion of burnt tissue on the cutting knife prevented conduction of the electric current.In addition, based on similar cases, the saline likely could not feed because the burnt tissue that was generated during the incision, adhered on the cutting knife or distal end cover which blocked the nozzle.As a result, the saline could not be feed and/or be injected.However, the root cause of these reported events could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not use this instrument with burnt tissue adhering to cutting knife or tip.Use the instrument after removing the burnt tissue adhering with a lint-free cloth.¿ this supplemental report includes information added to d8.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE ELECTROSURGICAL KNIFE KD-655
• 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: 16160090
• Report Number: 9614641-2023-00059
• Device Sequence Number: 17991149
• Product Code: KNS
• UDI-Device Identifier: 04953170377532
• UDI-Public: 04953170377532
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K171158
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date (Section B): 05/09/2023

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?: No
• Operator of Device: Health Professional
• Device Model Number: KD-655U
• Device Lot Number: 24K
• Was Device Available for Evaluation?: No
• 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: 12/22/2022
• Supplement Date Received by Manufacturer: 04/19/2023
• Initial Report FDA Received Date: 01/13/2023
• Supplement Report FDA Received Date: 05/09/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Unknown