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

Model Number HX-400U-30

Device Problems Detachment of Device or Device Component (2907); Mechanical Jam (2983)

Patient Problem Hemorrhage/Bleeding (1888)

Event Type  Injury  

Event Description

The customer reported to olympus that during an endoscopic polypectomy procedure, the stopper of the ligating device fell off into the patient, possibly into the colonic lumen.The stopper was retrieved from the patient with forceps.Upon attempt to ligate the polyp single use ligation device, the loop could not be tightened.The polyp was torn off causing hemorrhage.Hemostatic clips were used to achieve hemostasis.

Manufacturer Narrative

The lot was not provided, and the manufacture date cannot be identified since the subject device was not returned, therefore the production date cannot be determined.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

The following additional information regarding the event was provided: the subject device was not inspected prior to use.The patient currently has no health problems related to this event.

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, although the root cause of the event (tissue torn off with a loop) could not be determined, the event was likely due to the following mechanism: the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.The tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.An attempt was made to detach the loop in state of above description 2).Therefore, the loop detached from the hook in the tube.(see fig.1) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.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.(see fig.2) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.The loop was moved in state of ¿6¿ description.This had caused the ligated tissue to tear off.Furthermore, during the polypectomy procedure, the stopper of the subject device (hx-400u-30) reportedly fell into the patient's body.Although the root cause could not be determined, the issue was likely caused by the following: the slider was pulled before surrounding the target tissue with the loop.The loop stopper was detached from the distal end of the loop and fell off.The event can be detected/prevented by following the instructions for use (ifu) which state: ¿do not pull the slider before surrounding the target tissue with the loop.Otherwise, the loop stopper would be dislodged.¿.This supplemental report includes a correction to b2, b5 and g2 to provide information that was inadvertently not included in the initial medwatch.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: 16287762
• MDR Text Key: 308708503
• Report Number: 9614641-2023-00152
• Device Sequence Number: 1
• Product Code: FHN
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/27/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 06/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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): Other; Required Intervention