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 Hemorrhage/Bleeding (1888)

Event Date 10/02/2023

Event Type  Injury  

Event Description

An olympus representative initially reported on behalf of the customer that during an endoscopic mucosal resection (emr), it became impossible to release the loop after polyp ligation with the single use ligating device.The sheath could not be removed by operating the handle, and the sheath was cut.Since the polyp could not be cut with a loop cutter, the polyp was removed with an endoscopic submucosal dissection (esd) knife.Polypectomy was originally performed, but additional treatment was required due to the occurrence of this problem as excessive bleeding occurred.As such, treatment using hemostatic forceps was performed.The procedure and anesthesia were extended by 1 hour.Olympus received further information clarifying that the single use ligating device was used for excision of stromal polyps.The device was inspected prior to use without any abnormality noted.There was no further harm or user injury reported due to the event.

Manufacturer Narrative

The suspect device was returned to olympus for evaluation.The operator was not returned, only the cut sheath.The sheath was cut at a position of about 590 millimeters (mm) from the tip of the insertion part and at the base of the control part.A loop was built into the body and most of the loop was retracted into the coil sheath, with part of a stopper at the tip.Upon stretching the coil sheath and checking the condition of the hook and loop, it was discovered that the rear end of the loop was not properly connected to the hook and was sandwiched between the coil sheath and the hook.Destroying the actual product, the loop was removed from the coil sheath.The loop was not broken, and the rear end of the loop was deformed.There were no abnormalities such as deformation or bending on the hook.There were no other abnormalities that led to the events described.Initial evaluation verified that the loop is not released from the console.Due to damage to the actual product, a reproducibility check for the event that the loop could not be released could not be performed.The investigation is ongoing.Additional information is being requested from the user facility.A supplemental report will be submitted upon completion of the investigation.

Event Description

The user mentions that the incision of the incarcerated part with a hook knife, hemostasis with hemostatic forceps, and hemostasis with a clip.No other interventions that the patient received for bleeding (e.G., blood transfusions, fluids, long-term hospitalization for monitoring, etc.).No information that any special anomalies have occurred.Hx-400u-30 was used for the purpose of removing pedunculated polyps.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the legal manufacturer's final investigation and correction to the initial with information inadvertently left out.Additionally, to provide additional information received.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, it is likely the phenomenon "loops can no longer be released" occurred by the following mechanism described below: 1) the loop was surrounding the body tissue.2) the tube sheath was pushed out, and the body tissue was temporarily ligated by using the distal end of the tube sheath.3) the loop was tightened by pulling the slider.4) the slider was pushed while the distal end of coil sheath did not extend from the tube sheath.Therefore, the loop detached from the hook in the tube sheath.5) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.6) 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.7) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.However, the root cause of the phenomenon could not be identified.The event can be prevented by following the instructions for use 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." "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." "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." 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: 18012540
• MDR Text Key: 326626857
• Report Number: 9614641-2023-01589
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• 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,User Facility,Company Representative,Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/15/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 22K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/15/2023
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 11/08/2023
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Treatment: PCF-H290Z/UNKNOWN SERIAL NO.
• Patient Outcome(s): Required Intervention
• Patient Ethnicity: Non Hispanic
• Patient Race: Asian