MAUDE Adverse Event Report: OLYMPUS MEDICAL SYSTEMS CORP. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problem Break (1069)

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

Event Date 01/25/2022

Event Type  malfunction  

Event Description

It was reported during a therapeutic polypectomy procedure, upon release, the metal rod in the handle bent and broke.According to the reporter, the endoloop was then already around the polyp and it was impossible to get it out of there.The user then made the decision to cut the sheath of the endoloop at the bottom of the handle.Customer removed the endoscope leaving the sheath and endoloop in place.The user returned with the endoscope to the polyp next to the sheath of the endoloop.With a hot snare, user burned the endoloop free from the polyp.The user pulled on the sheath and it all came out.The intended procedure was completed with no patient harm or injury reported due to the event.No user injury reported.According to the reporter, "this was apparently the second time such an incident had occurred with the endoloop.The nurse had forgotten to call or write, to report the incident " and just mentioned it to the olympus representative (reporter) only on this event.In addition, the nurse stated that she is not 100% certain of the precise date of this incident.The nurse was advised asked to please take more notes next time.This report is related to a report with patient (b)(6).

Manufacturer Narrative

The subject device was returned to the service center for evaluation; however, the device evaluation is still pending.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on device return evaluation and the legal manufacturer's final investigation.Olympus service business center (sbc) received and evaluated the subject device.A visual inspection on the received condition performed and was unable to test the device as the manipulating wire in the slider was split in two approximately 40mm from the bottom of the slider.It was able to verify the insertion portion was detached approximately 55mm from the handle.Other than the cut on the insertion portion there were no signs of damages/kinks/dents found with the coil sheath, tube sheath and yellow tube joint.The lot number of the device was 06v with supplementary information number of ¿10¿.(m-bc manufacture date: jun 10, 2020).The dhr (device history record) with the lot number of the subject device was confirmed.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.Ifu (instruction for use) : 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.·never use excessive force to operate the instrument.This could damage the instrument.[conclusion summary].Based on the device evaluation result by sbc and the replication testing results in the past, a likely mechanism causing the reported event might be the following: 1) the loop was surrounding the body tissue, and it was temporarily ligated by pulling the slider.2) the tube sheath was pushed out, and the distal end of the coil sheath went into the tube sheath.3) an attempt was made to detach the loop in state of above description 2).Therefore, the loop detached from the hook in the tube.4) while the hook was extending from the coil sheath, the loop moved towards the proximal side and went into the coil sheath.5) 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.6) since the loop and the hook got stuck together inside the coil, the loop did not detach when the slider was pulled.7) the slider was continuously pulled back and forth in state of above description 6).This applied a force to the operating pipe causing it to bend and break.Other possibility is that the slider was operated with the coil sheath near the operating portion bent.This applied a force causing it to bend and break.However, the exact cause could not be conclusively identified.Olympus will continue to monitor complaints for this device.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8 507; JA 192-8507
• Manufacturer Contact: kazutaka matsumoto ; 2951 ishikawa-cho; hachioji-shi, tokyo-to 192-8-507 ; JA 192-8507 ; 426425177
• MDR Report Key: 13932512
• MDR Text Key: 298059509
• Report Number: 8010047-2022-05148
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: CA
• 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: 06/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2022
• 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: 06V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/28/2022
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/19/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/10/2020
• 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: ENDOSCOPE.