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

Model Number HX-400U-30

Device Problem Separation Problem (4043)

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

Event Date 11/02/2022

Event Type  malfunction  

Event Description

As reported , "when using the hx-400u-30 to ligate the polyp, although there was some resistance to pushing and pulling the handle from the beginning, when the polyp was ligated as it was, a problem occurred in which the loop could not be released.The sheath was cut with a nipper to remove the scope, and then the sheath was removed using a loop cutter.The procedure was completed as it was, and there was no health damage to the patient.It is unknown whether the loop was temporarily stopped".Per the report " the device was inspected before use", noted that there was a little resistance pushing and puling the handle".The intended therapeutic colon polypectomy procedure was completed using the same set of equipment.No harm was reported.No patient, no user injury reported due to the event.

Manufacturer Narrative

The subject device hx-400u-30 was returned for investigation.The lot number was 26k with supplementary information number of ¿09¿.(m-bc manufacture date: june 9, 2022) subject device inspection and evaluation, the following were noted: the loop was attached to the coil sheath.The distal end of the loop was severed.The sheath was severed at the distal end of the handle.The tube sheath was severed at approximately 2235 mm from the distal end of the tube sheath.The tube sheath was missing approximately 65-75 mm.The coil sheath was severed at approximately 2250 mm from the distal end of the coil sheath.Inspection of the broken areas of the coil sheath revealed the shape that was severed mechanically by using a tool.The operating pipe in the handle was broken.The loop was pulled in the direction of the distal end.However, the loop could not be withdrawn from the coil sheath.Condition of the connection between the loop and the hook was inspected by stretching the coil sheath.The rear end of the loop was properly connected to the hook.The subject device was teared down to remove the loop from the coil sheath.Deformation was not observed in the rear end of the loop.The hook presented no abnormalities such as deformation or bending.Other abnormalities that could lead to the reported event were not confirmed.The dhrs (device history records) for this product was reviewed.No abnormalities detected in the dhr for the following items which related to the reported phenomenon.·process inspection sheet ·quality inspection sheet ·nonconforming product report instruction for use: the instruction manual (drawing number: gk8332, revision number: 05) contains following warnings.·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.Based on the investigation result and similar cases in the past, a likely factor causing the reported phenomenon might be the following: ·the proximate side of the loop was temporarily retracted into the coil sheath, and the loop was caught in between the coil sheath and the hook.This prevented the slider from moving and the loop could not be detached from the coil sheath.Under these circumstances, the slider was forcefully operated.As a result, the operating pipe was bent and broken.Detachment fault of the loop was likely caused by the following mechanism below : 1) the loop was detached from the hook while the coil sheath was being retracted into the tube sheath, or the loop was hung on to the tissue and it was positionally fixed at the distal end of the tube.As a result, the loop was unable to release.2) the tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.3) since the tube sheath was pulled toward the proximate side, causing the tube to pull the loop.This caused the loop to retract into the coil sheath.As a result, the loop was caught in between the hook and inner surface of the coil, and the loop stopped moving.4) the slider was forcefully operated in state of ¿3¿ description.This had caused the operation pipe and to break.It can be inferred that the loop and sheath were severed for emergency measures.Olympus will continue to monitor complaints for this device.

Manufacturer Narrative

This supplemental report includes a correction to the following fields from initial medwatch: d4, g2 and h6.The added information was inadvertently not included on the initial medwatch.

• 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, amori 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: 15890248
• MDR Text Key: 307628862
• Report Number: 9614641-2022-00682
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse Practitioner
• Type of Report: Initial,Followup
• Report Date: 01/06/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 26K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2022
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/09/2022
• 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
• Treatment: LOOP CUTTER.SCOPE (UNKNOWN MODEL, SN).NIPPER.