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

Model Number HX-400U-30

Device Problems Mechanical Problem (1384); Material Split, Cut or Torn (4008)

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

Event Date 03/10/2022

Event Type  malfunction  

Event Description

Customer reported with an issue of device was unexpanded.As reported , during a diagnostic colonoscopy procedure, the small piece of plastic that holds the polyp is cut.Cause the polyp to be cut and not strangled.Tweezers difficult to handle.The customer reported no impact on the outcome of the procedure as a result of the issue reported.The intended procedure was completed.No patient harm or injury reported due to the event.No user injury reported.

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.

Event Description

Updates on event/problem reported: further communication, the customer conveyed the following information: once realized the polyloop was not working properly, it was removed and used another one.The second one worked great.No further information provided.

Manufacturer Narrative

This report is being supplemented to provide additional information based on customer response to follow up.Supplemental report(s) will be submitted should any relevant new information is available.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented based on the device return evaluation.Device inspection and evaluation, the following noted below : the customer returned a hx-400u-30 single use ligating device, (lot oxv 07) for evaluation due to "small piece of plastic that holds the polyp is cut.Caused the polyp to be cut and not strangled".The device was received in the original package that was open prior to receipt for inspection.Visual inspection on the received condition noted the plastic loop stopper, missing at the distal end.The loop was separated from the insertion portion when received.The lot number is displayed on the handle portion of the complaint device and is clear and legible.Inspected the device, ran fingertips along the insertion portion and did not note any crushed, bent, or broken areas.There were no sharp protrusions, burrs, or edges on the distal end of the insertion portion.The yellow tube joint is present and undamaged.The operating wire was normal prior to attempted testing.Functional testing performed : during functional inspection, the loop was tested according to the directions supplied in the instruction manual.The loop responds normal when manipulating the slider handle, but continues to fully close when deploying, due to to the missing stopper.A same model test ligating device used as comparison and noted without having something in place to target, the stopper would become dislodged, which is stated in the instruction manual.As per the ifu (instruction for use)."do not pull the slider before surrounding the target tissue with the loop.Otherwise, the loop stopper would be dislodged." further testing, it was noted the slider handle, and while coiling, damaged the operation wire, which was kinked and bent after the inspection.The complaint device was damaged during the evaluation.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the device evaluation and the legal manufacturer's final investigation.The device was received in the original package.Visual inspection of the returned device revealed that the plastic loop stopper was missing at the distal end, and the loop was separated from the insertion portion.The lot number was clearly displayed.Further visual examination of the device did not reveal any crushed, bent, or broken areas.There were no sharp protrusions, burrs, or edges on the distal end of the insertion portion.The yellow tube joint was present and undamaged.The operating wire was normal.The loop was functionally tested according to the directions supplied in the instruction manual.The loop was found to respond normally when manipulating the slider handle, however it continued to fully close during deployment because of the missing stopper.A device of the same model, containing the stopper, was tested for comparison.The testing confirmed that without having something in place to target, the stopper would become dislodged.This is also confirmed by the instructions for use (ifu) which states the following: "do not pull the slider before surrounding the target tissue with the loop.Otherwise, the loop stopper would be dislodged.·never use excessive force to operate the instrument.This could damage the instrument." additional testing was performed on the slider handle.It was noted that coiling had damaged the operation wire which was kinked and bent.A review of the device history record found no deviations that could have caused or contributed to the reported problem.No abnormalities were observed in the dhr for the following aspects which related to the reported event.Process inspection sheet.Quality inspection sheet.Nonconforming product report.The investigation confirmed the reported device problem.A definitive root cause for the reported problem was not established.However, based on a review of similar complaints in the past, it is probable that the reported event occurred according to the following mechanism: 1.The slider was pulled before surrounding the target tissue with the loop.2.The loop stopper was detached from the distal end of the loop and fell off.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): 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: 14054902
• MDR Text Key: 288894599
• Report Number: 8010047-2022-05979
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• 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: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 07/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2022
• 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: 0XV
• 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: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/06/2020
• 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: TWEEZERS