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

Model Number HX-400U-30

Device Problem Separation Failure (2547)

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

Event Date 06/24/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was returned to olympus for evaluation and the investigation is in process.During inspection of the returned device, the following observations were made: the coil sheath was cut at a position of approximately 226 cm from the tip.The coil sheath was stretched at a position of approximately 208 cm from the tip.The tube sheath was cut at a position of approximately 205 cm from the tip.No buckling or coil misalignment was observed in other parts of the coil sheath.A loop protruded from the tip of the coil sheath.The end of the loop was cut off.The loop did not have a stopper.The rear end of the loop hung on a hook in the coil sheath.The loop could not be pulled out of the coil sheath.The operation part was disassembled and the lid at the tip was removed.The operation pipe in the operation section was broken.The outer diameter of the operating pipe was measured, and no abnormality was identified.The coil sheath connected to the tip of the operation unit was disconnected.The coil sheath was cut near the tip of the coil receptacle, and the operation pipe came off on the hand side, exposing the two wires inside.The disconnected operation pipe was not returned.A tube near the tube fitting was cut.There were no abnormalities observed that could have led to the reported event.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.If additional information becomes available, this report will be supplemented accordingly.

Event Description

A nurse at the user facility reported that during a colonic polypectomy procedure, the physician tried to remove the loop after ligating a polyp with the subject device, but the sheath was kinked and the physician could not remove the loop.The sheath of the device was cut with nippers, the scope was reinserted, and the loop was released using a loop cutter.The loop was still ligating the polyp even after the release, but another loop was placed as a precaution, and the polypectomy was performed.The procedure was successfully completed with no health hazard to the patient.

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.It has been over 1 year since the subject device was manufactured.Based on the results of the investigation, it is likely that the operating wire was unable to operate due to the buckling of the coil sheath.This may have caused the loop not to detach from the hook.In addition, the coil sheath buckled at the portion protruding from the biopsy valve of the endoscope.It is likely that the coil sheath buckled due to excessive force applied to the coil sheath.However, the exact cause of the reported event could not be determined.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.¿ ¿never use excessive force to operate the instrument.This could damage the instrument.¿ 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 Contact: masaharu hirose ; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0-357 ; JA 036-0357 ; 426422891
• MDR Report Key: 15113100
• MDR Text Key: 304714019
• Report Number: 9614641-2022-00043
• 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,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/27/2022
• 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: 17K
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/30/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/23/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2021
• 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