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 09/05/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device was not returned to aomori olympus for the following reasons: the customer discarded the subject device.The subject device was manufactured on july, 2021 based on the provided 3 digit lot information ¿17v.¿ the manufacture date cannot be identified since the subject device was not returned.The dhrs (device history records) for this product have been reviewed and no abnormalities were detected in the device history record for the following inspection items which related to the reported phenomenon.Process inspection; quality inspection; nonconforming product report.Instruction for use (ifu): the device's instruction manual provides the following warnings which may help to prevent the issue: the instruction manual (drawing number: gk4574, revision number: 16) 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.The exact cause of detachment fault of the loop could not be conclusively identified by the following reason; ·the device was not retuned for the investigation.The subject device was not returned to olympus.Therefore, the reported phenomenon and condition of the device could not be confirmed.·no abnormalities on the device was considered as no abnormalities were found in the device history record.However, from a past similar case, detachment fault of the loop was likely caused by the mechanism below.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.The tube sheath was pulled toward the proximate side while the hook was extended from the distal end of the coil sheath.The pulling of the tube sheath caused the loop to move with the distal end of the tube sheath toward the coil sheath.Subsequently, the loop entered the coil sheath and got caught between the hook and the coil sheath.Olympus will continue to monitor complaints for this device.

Event Description

As reported, during a therapeutic polyloop application on stalked polyp procedure, the polyloop was placed over stalked polyp and tightened to cut off blood circulation.After placement while deploying the loop the handle malfunctioned and would not release the loop.The operator cut the handle off and the loop was manually released.The intended procedure was completed with no patient harm or injury due to the event.No user injury reported.

• 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: 15535196
• MDR Text Key: 306637185
• Report Number: 9614641-2022-00402
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: NZ
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 10/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/04/2022
• 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: 17V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 09/05/2022
• 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