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

Model Number HX-400U-30

Device Problem Failure to Disconnect (2541)

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

Event Date 05/23/2023

Event Type  Injury  

Event Description

The physician reported to olympus that after ligation, this single use ligating device loop did not detach.The tech assisted the physician and deployed the polyloop according to training but failed.The physician cut the inner metal wire in the catheter and used the guidewire to complete the deployment of the loop.The user noticed a hole in catheter about 2 centimeters from the tip.The procedure was completed with the same device.As reported to olympus, the device was inspected prior to use and the loop's protective sheath was removed; the yellow lever was used to open and close loop.The reported device failure occurred at the mid-way point of a colonoscopy procedure.Deployment of the loop took 5 minutes; no adverse health effect to the patient occurred which was attributed to the delay in procedure.There were no reports of patient or user harm associated with this event.

• 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: 17187397
• MDR Text Key: 317719038
• Report Number: 2429304-2023-00194
• 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: Physician
• Type of Report: Initial
• Report Date: 05/23/2023,06/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 28V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/23/2023
• Event Location: Hospital
• Date Report to Manufacturer: 05/23/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 06/22/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention