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

Model Number HX-400U-30

Device Problems Break (1069); Defective Device (2588)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

The subject device has not yet been received for evaluation.The cause of the issue cannot be determined at this time.The investigation is ongoing; therefore, the root cause of the reported event cannot be determined at this time.However, if additional information becomes available this report will be supplemented accordingly.

Event Description

It was reported a male patient on coumadin therapy presented with acute onset rectal bleeding.The patient underwent a sigmoidoscopy procedure in which a olympus flexible single use ligating device (polyloop) was placed around patient polyp mass, the loop was tightened however the loop would not release from the loading device/hook that was threaded through the endoscope.The user had to use a loop cutter to remove the loop from the scope.No known harm or injury to the patient.No user injury reported.

Manufacturer Narrative

This supplemental report is to advise that upon further review this is not a reportable malfunction.Per the legal manufacturer, there is no potential for this issue to cause or contribute to death or serious injury if the malfunction were to recur.

• 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: 11087454
• MDR Text Key: 224165914
• Report Number: 8010047-2020-11076
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170368615
• UDI-Public: 04953170368615
• 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,health
• Type of Report: Initial,Followup
• Report Date: 02/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• 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: 98V
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: SCOPE; SCOPE
• Patient Age: 95 YR
• Patient Weight: 107