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

Model Number SLK6LF

Device Problem Material Twisted/Bent (2981)

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

Event Date 08/17/2023

Event Type  malfunction  

Event 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.

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
• Type of Device: 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
• MDR Text Key: 323322641
• Report Number: 3011324403-2023-00002
• Device Sequence Number: 1
• Product Code: MND
• UDI-Device Identifier: 00850261006033
• UDI-Public: 00850261006033
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 09/13/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/13/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SLK6LF
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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