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

Model Number HX-400U-30

Device Problems Material Separation (1562); Device Fell (4014)

Patient Problems Hemorrhage/Bleeding (1888); Blood Loss (2597)

Event Date 09/11/2020

Event Type  Injury  

Manufacturer Narrative

The cause of the reported event could not be determined at this time.If additional information becomes available, this report will be updated accordingly.

Event Description

It was reported that the patient experienced bloody stool following an unspecified therapeutic procedure.Upon patient examination, the physician determined the loop of the device had come off.The physician attempted to stop the bleeding to no avail.As a result, the patient was sent to the hospital.Additional information is unavailable at this time.

Manufacturer Narrative

This report is being updated to provide investigation findings.The device history record (dhr) for the complaint device has been evaluated.All records indicate that the product was manufactured, tested in accordance with all applicable procedures, and met all final product release criteria.The instructions for use shipped with the device provides the user the following information related to the reported issue: in order to prevent the ligator loop from slipping off, care should be taken to ensure that there is adequate space remaining above the loop.Conclusion: the subject device was not returned for investigation.The exact cause of the reported event could not be identified.It can be inferred that the upper side of the ligation area did not have enough height.Therefore, the loop might have come off from the ligation area and bleeding might occur.

• 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: 10638189
• MDR Text Key: 214756504
• Report Number: 8010047-2020-07298
• 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: company representative,user f
• Type of Report: Initial,Followup
• Report Date: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/06/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 97V
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention