MAUDE Adverse Event Report: AOMORI OLYMPUS CO., LTD. SINGLE USE ELECTROSURGICAL SNARE SD-400

Model Number SD-400U-15

Device Problem Difficult to Remove (1528)

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

Event Date 03/05/2024

Event Type  Injury  

Manufacturer Narrative

Once the investigation has been completed, a supplemental report will be submitted with the device evaluation results.

Event Description

It was reported that when performing a cold polypectomy on a polyp with a lesion size of 5 mm ("cold cut" -therapeutic procedure) in the large intestine, the polyp could not be detached/torn when it was strangled with a single use electrosurgical snare.Due to the inability to perform polypectomy, the procedure was changed to "emr procedure" and the polyp was mechanically excised which could then be removed from the tissue ("the treatment was performed by locally injecting it into the treatment area without using high frequency") the procedure was extended; however, the delay is unknown.The procedure was completed by replacing the device.No additional medication was given to the patient no reports of health hazards to the patient.Futher procedural details and outcome of patient were requested but not available at the time of the report.

• Brand Name: SINGLE USE ELECTROSURGICAL SNARE SD-400
• Type of Device: ELECTROSURGICAL SNARE
• Manufacturer (Section D): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer (Section G): AOMORI OLYMPUS CO., LTD.; 2-248-1 okkonoki; kuroishi-shi, aomori 036-0 357; JA 036-0357
• Manufacturer Contact: todd brill ; 800 west park drive; westborough, MA 01581 ; 5082077661
• MDR Report Key: 18908881
• MDR Text Key: 337731994
• Report Number: 9614641-2024-00669
• Device Sequence Number: 1
• Product Code: FDI
• UDI-Device Identifier: 04953170408250
• UDI-Public: 04953170408250
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K172734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/14/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SD-400U-15
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2024
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention