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

Model Number HX-400U-30

Device Problems Break (1069); Mechanical Problem (1384); Separation Failure (2547); Separation Problem (4043)

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

Event Date 07/12/2022

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the reported problem is unknown at this time.Investigation is ongoing.This report will be supplemented accordingly following investigation.

Event Description

Customer reported that the polyloop did not work properly.According to the report, the customer used the polyloop as normal and when putting on the loop when releasing, something in the handle snapped, the iron spring was perpendicular to the opening of the handle, afterwards, the loop could no longer separated from the polyp and as a result two scopes were brought at the same time at the patient without having a view of the endoloop.According to the reporter, in the end, the procedure (therapeutic) was able to be completed successfully with no patient harm or injury reported.No user injury reported due to the event.

Manufacturer Narrative

This report is being supplemented to provide additional information based on the approved final investigation and device evaluation.A review of the device history record found no deviations that could have caused or contributed to the reported issue.Based on the results of the investigation, the operating pipe was broken and could not be operated.The coil sheath was buckled at the distal end of the supporting pipe.Investigation of the inside of the coil sheath revealed that the loop was retracted into the distal end of the coil sheath.The distal end of the loop was severed.The condition of the connection between the loop and the hook was inspected by stretching the coil sheath.The loop was properly connected to the hook.No deformation was observed in the rear end of the loop.The hook presented no abnormalities such as deformation or bending.However, the definitive root cause of the ligating device malfunction could not be determined.It is possible that the loop was unable to be released from the hook due to the sheath being bent near the handle, the operation wire being unable to move due to increased sliding resistance between the sheath and operating wire, or the operating pipe having broken or deformed due to the forceful operation of the slider.The instruction manual identifies the following verbiage, which may have prevented the phenomenon: 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): OLYMPUS MEDICAL SYSTEMS CORP.; 2951 ishikawa-cho; hachioji-shi, tokyo 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: 15194533
• MDR Text Key: 297890960
• Report Number: 8010047-2022-12129
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: CLASS2-EXMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/09/2022
• 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: V2223 / 22V
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/22/2022
• 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: 2 SCOPES (SERIAL.MODEL NOT PROVIDED)