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U.S. Department of Health and Human Services

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

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AOMORI OLYMPUS CO., LTD. SINGLE USE INJECTOR; INJECTOR AND SHEATHSET Back to Search Results
Model Number NM-401L-0425
Device Problem Failure to Prime (1492)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/26/2023
Event Type  malfunction  
Event Description
An olympus representative reported to olympus on behalf of the customer that the single use injector was when needle was engaged solution would not come out of the syringe during the therapeutic laryngeal injection procedure.The intended procedure was completed with another similar device.There were no reports of patient harm or impact associated with the reported event.This report is related to linked patient identifier (b)(6).
 
Manufacturer Narrative
The device was returned to olympus for evaluation, and the customer's allegation was confirmed.Additional evaluation findings were as follows: the syringed was attached to the injection port of the device and was unable able to pass fluid through the distal end needle, however, the fluid only comes out from the distal end sheath when the needle was not extended (disengaged), and there were no dents/kinks noted with the insertion section sheath or external damages with the device.The evaluation did not find any signs of foreign objects/materials/debris inside the insertion sheath.The needle opening on the device from the distal end was also inspected with olympus microscope and no indication of objects/debris/materials were noted inside.The investigation is ongoing.A supplemental report will be submitted upon completion of the investigation.
 
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 definitive root cause of the syringe failure could not be determined.It is possible that the syringe failure occurred due to compressive buckling as a result of the needle being extended or retracted while the tube was coiled in inspection of the operation, the slider was abruptly pushed, or due to the angle of the distal end of the endoscope.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: ¿¿before use, prepare and inspect the instrument as instructed below.Should the any irregularity be observed, do not use the instrument; use a spare instead.Damage or irregularity may compromise patient or user safety, for example :posing an infection-control risk, causing tissue irritation, perforation, bleeding or mucous membrane damage, and may result in more severe equipment damage.·straighten out the instrument before inspecting it.The instrument can be damaged if it is coiled while the handle is operated.¿do not coil the insertion portion with a diameter of less than 15 cm.This could damage the insertion portion.¿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.¿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.¿when inserting the instrument into the endoscope, retract the needle into the tube, hold the instrument close to the biopsy valve, and keep it as straight as possible relative to the biopsy valve.Otherwise, the instrument could be damaged.¿stop using the instrument if the insertion portion bends excessively during use.This could result in malfunction, such as failing to extend the needle or inject a fluid.¿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.¿ olympus will continue to monitor field performance for this device.
 
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Brand Name
SINGLE USE INJECTOR
Type of Device
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 Key17581223
MDR Text Key321768276
Report Number9614641-2023-01194
Device Sequence Number1
Product Code FBK
UDI-Device Identifier04953170422638
UDI-Public04953170422638
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K902736
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility,Company Representative
Reporter Occupation Administrator/Supervisor
Type of Report Initial,Followup
Report Date 08/31/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/20/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberNM-401L-0425
Device Lot Number2XV 24
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/11/2023
Was the Report Sent to FDA? No
Date Manufacturer Received08/24/2023
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/23/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse
Patient Sequence Number1
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