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

Model Number	KD-655Q
Medical Device Problem Code	Failure to Pump (1502)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, during the submucosal dissection, there was a problem with the single use electrosurgical knife and they were not injecting.The procedure was completed with another device.The normal duration of the procedure is 1 hour and this procedure took an additional 30 minutes.There was no consequences to the patient and there was no prolonged hospitalization.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.The subject device was manufactured on january 2024 based on the provided 3 digit lot information "41k".However, the exact manufacture date is unknown.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 and past similar cases, it is likely that burnt tissue generated during incision adhered on the cutting knife or distal end cover blocked the nozzle.As a result, fluids possibly could not be injected.However, the subject device was not returned, and the root cause of the reported event could not be determined.The event can be detected/prevented by following the instructions for use 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." 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: 19661404
• Report Number: 9614641-2024-01370
• Device Sequence Number: 20561372
• Product Code: KNS
• UDI-Device Identifier: 04953170377518
• UDI-Public: 04953170377518
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/23/2024

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?: No
• Operator of Device: Health Professional
• Device Model Number: KD-655Q
• Device Lot Number: 41K
• 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: 06/13/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/02/2024
• Supplement Report FDA Received Date: 07/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: EVIS SCOPE 7351290; FLUSHING PUMP OFP-2 22310620; GASTROSCOPE GIFTH190-2345448; GENERATOR ESG300 B002957; PUMP EGA-500E 13131057
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Male