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 08/23/2023

Event Type  Injury  

Event Description

The olympus representative reported on behalf of the customer that during the colonoscopy with lesion removal and after the ligation, the endoloop on the single use ligating device deployed correctly however, it remained attached to the spring.The emergency loop cutters were used to cut the string externally and the scope was removed over the endoloop catheter.The colonoscope was then reinserted and the loop cutter was used again to cut the endoloop from the spring/catheter, which was later completely removed.The user was able to use the emergency cutter to detach the loop and the procedure was completed.The loop stayed with the patient and eventually passed.The procedure lasted 79 minutes and was not prolonged.The anesthesia/sedation was extended approximately five to seven minutes to troubleshoot the device.The condition of the patient was not impacted by the failure.No further medical intervention was required as a result of the reported problem.

• 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: 17818758
• MDR Text Key: 324278274
• Report Number: 2429304-2023-00301
• 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