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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE

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AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE Back to Search Results
Model Number HX-400U-30
Device Problem Failure to Disconnect (2541)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 05/29/2023
Event Type  malfunction  
Manufacturer Narrative
The device referenced in this report has not been returned to olympus for evaluation.The investigation is ongoing.The definitive cause of the user¿s experience cannot be determined at this time.A supplemental report will be submitted upon completion of the investigation or if any additional information is provided by the user facility.
 
Event Description
The customer reported to olympus that the single use ligating device loop was difficult to detach from the polyp-loop.The event occurred during an unknown therapeutic procedure.It was reported that the procedure was completed using another similar device.The customer reported that the loop was detached by following the instruction manual and no loop cutter procedure occurred.There was no report of patient harm or user injury associated with this event.
 
Manufacturer Narrative
This report is being supplemented to provide additional information based on the legal manufacturer's final investigation.Please see updates to h4, h6 and h10.H4: based on the 3 digit lot number provided, the manufacturing date of the device was in the month of june 2022 but a specific date could not be identified.A review of the device history record found no deviations that could have caused or contributed to the reported issue.The device was discarded by the customer.However, based on the results of the investigation, likely mechanisms causing the reported event (loop was difficult to detach from the polyp-loop) include: mechanism 1: 1) the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.2) the tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.3) an attempt was made to detach the loop in state of above description 2).Therefore, the loop detached from the hook in the tube.4) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.5) the hook was pulled.This caused the hook and the loop to retract into the coil sheath together.As a result, the loop and the hook got stuck inside the coil and could not move.6) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.Or mechanism 2: 1) the sheath was bent near the handle.2) the operating wire could not move because sliding resistance between the sheath and the operating wire increased.3) the operating pipe deformed or broke because the slider was forcefully operated.(see fig.4) 4) due to above, the loop could not detach from the hook.The following is included in the instructions for use: ¿do not strike or crush the coil sheath during operation.Doing so can damage the distal end of the coil sheath, which could make it impossible to detach the loop after ligation.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.Do not remove the loop from the hook while the coil sheath is not extended from the tube sheath.Otherwise, the loop may be tangled with the hook and become impossible to be removed.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.Do not hold the loop with the distal end of the tube sheath while the loop is surrounding the tissue.Otherwise, when the tissue is ligated, the loop may be detached from the hook in the tube sheath and tangled with the hook.That may make the loop impossible to be removed.In this case, refer to section 12, ¿emergency treatment¿ and as shown ¿equipment to be used in an emergency¿ on page 3 in this manual.Never use excessive force to operate the instrument.This could damage the instrument.Straighten out the portion of the instrument that extends from the biopsy valve.¿ olympus will continue to monitor field performance for this device.
 
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Brand Name
SINGLE USE LIGATING DEVICE
Type of Device
SINGLE USE LIGATING DEVICE
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 Key17390238
MDR Text Key320675346
Report Number9614641-2023-01027
Device Sequence Number1
Product Code FHN
UDI-Device Identifier04953170194641
UDI-Public04953170194641
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
CLASS2-EXMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Other,Foreign,User Facility
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 08/16/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberHX-400U-30
Device Lot Number26K
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? No
Initial Date Manufacturer Received 06/26/2023
Initial Date FDA Received07/25/2023
Supplement Dates Manufacturer Received08/03/2023
Supplement Dates FDA Received08/16/2023
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured06/01/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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