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

Model Number HX-400U-30

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 08/18/2022

Event Type  Injury  

Event Description

The customer reports during an unspecified procedure using a single use poly loop, the handle broke when trying to deploy the loop.The device was stuck inside the patient.The user was able to remove the device endoscopically with no further consequences to the patient.

• 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: 15427433
• MDR Text Key: 299963116
• Report Number: 2429304-2022-00057
• 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: Nurse
• Type of Report: Initial
• Report Date: 08/18/2022,09/15/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2022
• 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: 26V
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 08/18/2022
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention