MAUDE Adverse Event Report: US Endoscopy SmartBand SafeGrip Multi-Band Ligation Kit

Model Number	SLK6LF
Medical Device Problem Code	Failure to Advance (2524)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The user facility reported that during a patient procedure, multiple attempts were made to deploy the smartband safegrip multi-band ligation kit following successful tissue capture.The procedure was completed successfully; however, a procedural delay was reported as the facility had to use another device before continuing the procedure.
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris for evaluation.Without the returned device, a cause of the reported event could not be determined.The instructions for use states, "refer to package label for minimum channel size for this device.Esophageal ligation devices are not intended for ligation of varices below the gastroesophageal junction.Passing endoscope over a previously placed band may dislodge band.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.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.Note: keep the deployment cord clear of the barrel and endoscope, so that it does not become caught.Lubricate endoscope and exterior portion of barrel.Caution: do not place lubricant inside of barrel.Caution: do not apply alcohol to device." the device history record for the subject lot was reviewed and confirmed the device was manufactured to specifications; no abnormalities were noted.A complaint review was conducted for this lot of products and confirmed this to be an isolated event.No additional issues have been reported.

• Brand Name: SmartBand SafeGrip Multi-Band Ligation Kit
• Common Device Name: Multi-Band Ligation Kit
• Manufacturer (Section D): US Endoscopy; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US Endoscopy; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: daniel davy ; 5976 heisley road; mentor, OH 44060 ; +1(440)259-7401
• MDR Report Key: 50006441
• Report Number: 1528319-2026-00090
• Device Sequence Number: 21446934
• Product Code: MND
• UDI-Device Identifier: 00724995247331
• UDI-Public: (01)00724995247331(11)250805(17)270805(10)12614032
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/23/2026

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: SLK6LF
• Device Catalogue Number: SLK6LF
• Device Lot Number: (10)12614032
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 07/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/05/2025
• 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