MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE 3-LUMEN NEEDLE KNIFE V

Model Number	KD-V451M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	08/05/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report has been evaluated by olympus.The investigation is ongoing.Device manufacture date: the device was manufactured in september 2021.Physical evaluation of the suspect device revealed the customer's allegation was confirmed.Inspection of the returned device found the knife was missing from the device, and a burn mark was confirmed at the distal end.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.
Event or Problem Description
The customer reported during an endoscopic retrograde cholangiopancreatography (ercp) procedure, the knife "dropped out" while physician was cutting the ampulla.Consequently, the knife became stuck in the mucosa, and the physician was able to retrieve the suspect device using forceps.There was a procedural delay of approximately 10 minutes, and the procedure was completed.
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 over 1 year since the subject device was manufactured.Based on the results of the investigation, although the root cause could not be identified, it is likely that following factors might have caused the electrical discharge that led to the breakage of the cutting knife: 1.The setting value for the output activation was high.2.The output activation time was long.3.The cutting knife had not been kept moving.4.The length of contact between the tissue and the cutting knife was short.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿always operate the electrosurgical unit at the minimum output level and for the minimum time necessary to successfully complete the procedures.Excessive output level and time may result in patient injury, such as perforation, bleeding, or mucous membrane damage.¿ ¿when applying output, keep moving the cutting knife.When the knife stops and touches tissue at a point, concentrated electric current could cause the distal tip of the knife to dissolve and come off in the body.¿ this supplemental report includes information added to g2 and h4.Also, correction made to e1 from the initial medwatch.Olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE 3-LUMEN NEEDLE KNIFE V
• Common Device Name: SINGLE USE 3-LUMEN NEEDLE KNIFE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15350353
• Report Number: 9614641-2022-00267
• Device Sequence Number: 12063072
• Product Code: KNS
• UDI-Device Identifier: 04953170382710
• UDI-Public: 04953170382710
• Combination Product (Y/N): N
• Initial Reporter Country: SN
• PMA/510(K) Number: K955247
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 11/10/2022

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-V451M
• Device Lot Number: 19K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2022
• 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: 08/08/2022
• Supplement Date Received by Manufacturer: 10/13/2022
• Initial Report FDA Received Date: 09/02/2022
• Supplement Report FDA Received Date: 11/10/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2021
• 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: Other; Required Intervention
• Patient Sex: Unknown