MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET

Model Number	NM-400U-0425
Medical Device Problem Codes	Break (1069); Difficult to Insert (1316)
Health Effect - Clinical Codes	Foreign Body In Patient (2687); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/05/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
This report is being supplemented to provide additional information received as reflected in b5.Updates are added to the following fields: b1, b2, b5, h1, and h6.
Event or Problem Description
It was noted that the injector needle was broken inside the patient in an unspecified case.There is no further information received at this time.
Additional Manufacturer Narrative
The evaluation of the event is ongoing.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported the injector and sheath set had multiple issues during an unspecified procedure.The issues included the following: it was hard to open and close the needle, normal saline could not be injected smoothly, it was hard to punch the needle into tissue, after injection a hematoma occurred, and the needle was broken.Additional information regarding the procedure, hematoma severity, interventions taken, and patient outcome were requested, but not provided.At this time, there is no evidence that any additional treatment was provided for the hematoma.There is no evidence that a life-threatening event occurred, that the patient developed permanent damage or impairment, or that additional medical/surgical intervention was done to prevent permanent damage or impairment.The event will be reassessed should additional information become available.
Additional Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's (lm) 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.The subject device was not returned to olympus for evaluation.Based on the results of the investigation, it was determined that the inability to inject liquid into the target tissue likely occurred due to the compressive bucking on the needle tube.It was likely that the friction between the outer tube and the needle increased by the following factors: the needle extended/retracted while the tube was coiled in inspection of operation, the slider was abruptly pushed, the kink of the tube, and/or the angle of the distal end of the endoscope.However, since the device was not available for evaluation, the cause of the broken needle and reported hematoma could not be identified.The event can be detected/prevented by following the instructions for use (ifu) which states: ¿this instruction manual contains essential information on using this instrument safely and effectively.Before use, thoroughly review this manual and the manuals of all equipment that will be used during the procedure and use the instruments as instructed.If you have any questions or comments about any information in this manual, please contact olympus.¿ ¿the operator of this instrument must be a physician or medical personnel under the supervision of a physician and must have received sufficient training in clinical endoscopic technique.This manual does not explain or discuss clinical endoscopic procedures.¿ ¿before use, inspect the insertion portion and the tube for damage.Do not use the instrument if either component is crushed or excessively bent or any other damaged has been detected.Confirm that the needle can be smoothly extended from and retracted into the tube.Do not use the instrument if it cannot be operated smoothly.Otherwise, the needle may not properly extend from and/or withdraw into the sheath.The extended needle could cause perforation, bleeding, mucous membrane damage or inflammation of tissues, and/or damage the endoscope.If needle operation is lost or becomes difficult during a procedure, stop the procedure immediately and withdraw the needle and the endoscope from the patient.¿ ¿before use, confirm that the needle and the insertion portion are not damaged.If any abnormalities such as significant deformations or excessive bends are found, do not use the instrument.Otherwise, it may cause perforation, bleeding, mucous membrane damage.¿ ¿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, do not use the instrument.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.It may also damage the endoscope and/or instrument.¿ ¿confirm that the needle extends in the endoscopic image are normal.If any abnormalities are found, do not use the instrument.Otherwise, it may cause perforation, bleeding or mucous membrane damage.¿ ¿do not angulate the endoscope¿s bending section abruptly while the distal end of the insertion portion is extended from the distal end of the endoscope.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.¿ ¿do not force the distal end of the insertion portion against body cavity tissue.This could cause patient injury, such as perforation, bleeding or mucous membrane damage.¿ ¿do not insert the instrument into the endoscope when the needle is extended.The distal end of the insertion portion may extend from the endoscope distal end abruptly.This 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 of the endoscope until the instrument passes smoothly.Attempting to force the instrument could cause patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the endoscope and/or instrument.¿ ¿do not push the slider abruptly, otherwise the needle will be rapidly extended from the distal end of the tube.This could result in patient injury, such as perforation, bleeding or mucous membrane damage.It could also damage the instrument.¿ ¿while piercing tissue and injecting fluid, always hold the holder portion and slider.Otherwise, patient injury, such as bleeding could result.¿ ¿do not pierce tissue with excessive force.This could result in patient injury, such as perforation, bleeding or mucous membrane damage.¿ olympus will continue to monitor field performance for this device.

• Brand Name: SINGLE USE INJECTOR
• Common Device Name: INJECTOR AND SHEATHSET
• 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: 20340511
• Report Number: 9614641-2024-01900
• Device Sequence Number: 7805422
• Product Code: FBK
• UDI-Device Identifier: 04953170259937
• UDI-Public: 04953170259937
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K902736
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/31/2025

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: NM-400U-0425
• Device Lot Number: 46K
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/05/2024
• Supplement Date Received by Manufacturer: 10/03/2024; 01/15/2025
• Initial Report FDA Received Date: 09/30/2024
• Supplement Report FDA Received Date: 10/04/2024; 01/31/2025
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown