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

Model Number	SLK6LF
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/17/2023
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a patient procedure the banding string from their multi-band ligation kit became knotted resulting in a procedure delay.
Additional Manufacturer Narrative
The product specialist reported that there are no pictures of the device available, and the issue occurred right out of the package prior to patient use.The device was not returned for investigation and the reported issue could not be determined.The lot number of the product could not be provided.Without the lot number, the device history record could not be reviewed.The instructions for use (ifu) gives the user the following information to the user: "place barrel on tip of endoscope.Then, advance barrel using a continuous rocking motion until scope tabs stop the barrel.Correct barrel placement can be verified when you cannot see the scope tabs on the monitor.Note: do not use excessive force when advancing the barrel onto the endoscope.Remove barrel by turning in a counterclockwise motion, twisting barrel off the endoscope.Note: do not use excessive force to remove the barrel from the scope.Attach deployment cord loop onto ligation handle hook feature.With deployment cord secure on ligation handle, rotate ligation handle slowly to remove the extra slack in the deployment cord.Note: putting too much tension on the deployment cord can cause premature band deployment.If package is opened or damaged when received, do not use.Visually inspect with particular attention to kinks, bends and breaks.If abnormality is detected that would prohibit proper working condition, do not use.Please notify intelligent endoscopy for return authorization.Olympus/fujifilm endoscopes: insert handle stem with preloaded universal connector into accessory channel port ensuring it forms a complete seal and secure fit around the metal port.Lubricate endoscope and exterior portion of barrel.Caution: do not place lubricant inside of barrel.Caution: do not apply alcohol to device." no additional issues have been reported.

• Brand Name: SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT
• 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: 17739587
• Report Number: 3011324403-2023-00002
• Device Sequence Number: 17795906
• Product Code: MND
• UDI-Device Identifier: 00850261006033
• UDI-Public: 00850261006033
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: SLK6LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/17/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 09/13/2023
• Supplement Report FDA Received Date: 10/17/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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