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 04/27/2021

Event Type  Injury  

Manufacturer Narrative

Olympus (b)(4) provided the information as follows.Repair history of the item.Repair history: there is no repair record since it is a disposable product.Occurrence of similar event in this facility.Hx-400u-30 of this hospital has not been repaired for this event since it is a disposable product.The disposable product has been opened for use, and the product was not returned.The subject device referenced in this report has not yet been completed omsc's evaluation.Therefore the exact cause of the reported event could not be conclusively determined at this time.A supplemental report will be submitted, if additional or significant information becomes available at a later time.

Event Description

Olympus medical systems corp.(omsc) was informed by the user facility that during the surgery of purse-string suture using the subject device, the snare was broken when tighten up, causing the failure of suture.The broken part was retrieved.No patient injury reported.The subject device was used with gif-q260j.The surgery was discontinued and finished at surgical department.

Manufacturer Narrative

This is a supplemental report to provide additional information.The subject device was not returned to olympus medical systems corp.(omsc) for investigation.The devices combined with the subject device is below; according to ocsm lei wang, the medical instrument combined with the loop was the titanium clamp produced by nanjing minimally invasive medical technology co., ltd.The model number was rocc- d-26-165c while its photo was not available.The subject device was not returned for investigation.However, the picture was provided in the etq.According to the provided picture, one breakage of the loop was confirmed near the stopper.However, the condition of the broken portion could not be confirmed.The device history records below were reviewed for the lot.The review revealed the lot had passed all the event-related inspection items.-nonconforming product report.[replication test] the following replication test of the loop breakage was carried out.However, the shape of the broken loop could not be confirmed.Therefore, it was not possible to compare the returned loop and the loop that was used for the replication test, and the exact cause of the reported event could not be determined.1) replication test was carried out by pulling both sides of the loop strongly.However, the breakage of the loop could not be replicated.2) replication test was carried out by severing the loop by single edge cutter.It was confirmed that the surface of the broken portion was smooth.3) replication test was carried out by contacting the loop with the snare while electrosurgical snare was activating.The breakage of the loop was confirmed.It was also confirmed that the broken portion was melted, and it became round.[conclusion summary] the provided picture alone could not be confirmed the condition of the broken area.Dhr presented no abnormalities.Therefore, the exact cause of the reported event could not be determined.It is possible that the following factor causing the loop breakage, and the procedure could not be completed.Therefore, the procedure might have changed to surgical procedure.1) the loop came into contact with something sharp.This caused the loop to break.2) the loop was in contact with the electrosurgical unit causing the loop to melt and break.Since the root cause of this event could not be determined, we will continue to monitor trends and take appropriate actions as necessary.The instruction manual (drawing number: gk4574, revision number: 15) contains following warnings.When the tissue is to be resected using an electrosurgical snare after ligature, make sure that the electrosurgical snare and loop are not in contact with each other before activating the output.If the output is activated when the electrosurgical snare and loop are in contact as shown in figure 1, the loop could be cut, resulting in patient injury, such as hemorrhages or mucous membrane damage.It may also fuse the loop and electrosurgical snare together, preventing removal of the electrosurgical snare.

• 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
• MDR Report Key: 11873859
• MDR Text Key: 252298076
• Report Number: 8010047-2021-06697
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Type of Report: Initial,Followup
• Report Date: 07/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: HX-400U-30
• Device Lot Number: 12K
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/29/2021
• Initial Date FDA Received: 05/24/2021
• Supplement Dates Manufacturer Received: 07/21/2021
• Supplement Dates FDA Received: 07/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention