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

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/27/2022

Event Type  Injury  

Manufacturer Narrative

The device referenced in this report has been returned to olympus.The evaluation is not yet completed.The investigation is ongoing.This report will be updated upon completion of the investigation or upon receipt of additional relevant information.

Event Description

The customer reports during a polypectomy procedure using a single use ligating device, the loop could not release, the inner wire broke in/at the handle.Loop was well around the polyp, colored purple and then it had to be released.Pushing the handle system forward, the thin wire, where the hook is located at the end, shot into the handle.You could see 2 vulnerable spots on that wire.The colleague who placed the endoloop is very experienced and did not force anything.Immediately stopped.After consultation, it was decided to cut the system at the handle.The scope could therefore be removed from the patient and the scope was reinserted with an endoloop cutter.The endoloop system therefore remained behind in the patient.After that the endoloop was cut with the endoloop cutter the system be removed from the patient.Then loops and clips were used, and the user was able to remove the polyp.Luckily, we still had an endoloop cutter, otherwise i don't know if we were able to remove the endoloop system from the patient.The procedure took about half an hour longer.The patient received the treatment under propofol, she had a deep sleep and did not experience any of the procedure.The patient has had no adverse effects from the procedure.It was just a bit of a thrill for the doctor and nurses performing the procedure, how to remove the endoloop without damaging the patient and scope.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and device evaluation.The device was returned to olympus for inspection, and the findings are as follows: the customer¿s reported complaint was confirmed.The operating pipe in the handle was deformed and bent in two positions.The loop was not attached to the hook.The coil sheath was severed at 2300 mm from its distal end.The tube sheath was severed at 2190 mm from its distal end.The tube sheath was missing approximately 150 mm.An inspection of the broken area of the coil sheath revealed the shape that was severed mechanically by using a tool.The distal side of the loop and stopper were severed.The rear side of the loop had dent marks that the hook was strongly pressed to.No other abnormalities were found.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, the reported event was likely cause by the following mechanism: 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 the 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.7) the slider was forcefully operated in state of ¿6¿ description.This had caused the operation pipe to deform.Furthermore, it can be inferred that the loop and sheaths were severed for emergency measures.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿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 remove.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 remove.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.¿ this supplemental report includes information added to h4.Also, h3 has been updated to ¿yes.¿ olympus will continue to monitor field performance for this device.

• 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 Key: 16033327
• MDR Text Key: 305981457
• Report Number: 9614641-2022-00841
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 04/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/22/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 23V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/14/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 04/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/21/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention