MAUDE Adverse Event Report: INTELLIGENT ENDOSCOPY SMARTBAND MULTI-BAND LIGATION SYSTEM; LIGATOR

Model Number	SLK-6-LF
Medical Device Problem Code	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure which included use of their smartband multi-band ligation system an area of bleeding in the patient's throat was noted.No medical intervention was administered.The patient is reported to be doing fine.The procedure was completed successfully utilizing the ligation system.
Additional Manufacturer Narrative
The ligation system subject of the reported event will be returned for evaluation.The device history record was reviewed and confirmed that the device was manufactured to specification.There have been no other complaints associated with this lot.Intelligent endoscopy's distributor will offer in-service training on the proper use and operation of the smartband multi-band ligation system.A follow-up mdr will be submitted should additional information become available.
Additional Manufacturer Narrative
The ligation system subject of the reported event was returned for evaluation.The evaluation confirmed that the device was smooth as designed and no abnormalities were identified.The reported event is likely attributed to the intubation process of the patient during the procedure.No additional issues were noted.

• Brand Name: SMARTBAND MULTI-BAND LIGATION SYSTEM
• Common Device Name: LIGATOR
• Manufacturer (Section D): INTELLIGENT ENDOSCOPY; 4740 commercial park ct ste 1; clemmons NC 27012
• Manufacturer (Section G): INTELLIGENT ENDOSCOPY; 4740 commercial park ct ste 1; clemmons NC 27012
• Manufacturer Contact: coletta cohara ; 4740 commercial park ct ste 1; clemmons, NC 27012 ; 4403586251
• MDR Report Key: 12967383
• Report Number: 3011324403-2021-00001
• Device Sequence Number: 13829281
• Product Code: MND
• UDI-Device Identifier: 00850261006033
• UDI-Public: 00850261006033
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2021

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?: No
• Operator of Device: Health Professional
• Device Model Number: SLK-6-LF
• Device Catalogue Number: IE11004
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/26/2021
• Supplement Date Received by Manufacturer: 11/26/2021
• Initial Report FDA Received Date: 12/09/2021
• Supplement Report FDA Received Date: 03/25/2022
• Date Device Manufactured: 09/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown