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

Model Number	KD-V441M
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/11/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device referenced in this report was not returned to olympus for evaluation.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
Event or Problem Description
The olympus employee reported on behalf of the customer that the single use 3-lumen needle knife v was stuck in the evis lucera duodenovideoscope channel and came off during an unknown procedure.Needle knife dropped inside the patient¿s body.Nothing was left inside the patient as the broken parts were retrieved from the patient.No clinical impact and procedure completed with the same scope.No delay was reported.No patient harm was reported.The following 2 patient identifiers for below 2 olympus devices that were involved during a single event.1) patient identifier # (b)(6), single use 3-lumen needle knife v, model: kd-v441m; serial number- unknown (this report).2) patient identifier # (b)(6), evis lucera duodenovideoscope, model tjf-260v; serial number- (b)(6).
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, it is likely that the reported defect (knife wire fell off requiring retrieval) occurred because an excessive bending force was applied to the knife wire.This may have caused the cutting wire to break.However, the root cause could not be determined.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not move the slider rapidly.This could damage the instrument.Do not insert the instrument into the endoscope unless you have a clear endoscopic field of view.If you cannot see the distal end of the insertion portion in the endoscopic field of view or in x-ray images, do not use it.This could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It may also damage the endoscope and/or instrument.Do not insert the instrument into the endoscope while the cutting knife is extended.Otherwise, the distal end of the insertion portion may extend from the distal end of the endoscope abruptly, which could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.Do not force the instrument if resistance to insertion is encountered.Reduce the angulation or lower the forceps elevator of the endoscope until the instrument passes smoothly.Forced insertion could cause patient injury, such as perforation, bleeding, or mucous membrane damage.It could also damage the endoscope and/or instrument.¿ this supplemental report includes a correction to h6 code (type of investigation).Code ¿10¿ has been corrected to code ¿4114," since the subject device was not returned to olympus for evaluation.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 (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: 18466547
• Report Number: 9614641-2024-00036
• Device Sequence Number: 16922876
• Product Code: KNS
• UDI-Device Identifier: 04953170382703
• UDI-Public: 04953170382703
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• 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,Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 06/20/2024

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-V441M
• 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: Not provided
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 06/20/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: DUODENOVIDEOSCOPE, MODEL TJF-260V, SN-(B)(6).
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown