MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE LIGATING DEVICE

Model Number HX-400U-30

Device Problem Difficult to Remove (1528)

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

Event Date 08/28/2023

Event Type  Injury  

Event Description

The olympus representative reported on behalf of the customer that during the sigmoidoscopy with endoscopic ultrasound-guided (eus) fine needle aspiration (fna) and after the ligation, they were unable to deploy the loop on the single use ligating device.The user was able to use the emergency loop cutter to detach the loop and the procedure was completed.The loop stayed with the patient and eventually passed.The procedure lasted 39 minutes and was not prolonged.The anesthesia/sedation was extended approximately seven to eight minutes to troubleshoot the device and obtain additional polyloops from the supply room.The condition of the patient was not impacted by the failure.

• Brand Name: SINGLE USE LIGATING DEVICE
• Type of Device: SINGLE USE LIGATING DEVICE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• MDR Report Key: 17818567
• MDR Text Key: 324275566
• Report Number: 2429304-2023-00300
• 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: Distributor
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/28/2023,09/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/26/2023
• 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: 2XV
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/28/2023
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/28/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNKNOWN COLONOSCOPE
• Patient Outcome(s): Required Intervention