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

Model Number HX-400U-30

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Hemorrhage/Bleeding (1888); Melena (4480)

Event Date 09/11/2020

Event Type  Injury  

Event Description

It was reported 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.Cross reference the manufacturer's report #  8010047-2020-07298.

• 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: 10638358
• MDR Text Key: 210379894
• Report Number: 2951238-2020-00503
• Device Sequence Number: 1
• Product Code: FHN
• UDI-Device Identifier: 04953170194641
• UDI-Public: 04953170194641
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 09/11/2020,10/06/2020

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?: No
• Device Operator: Health Professional
• Device Model Number: HX-400U-30
• Device Lot Number: 97V
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 09/11/2020
• Date Report to Manufacturer: 09/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention