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

Model Number	SLK6LF
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is currently in progress.Steris has requested that the smartband safegrip multi-band ligation kit be returned for evaluation.A follow-up report will be submitted when additional information becomes available.
Event or Problem Description
The user facility reported that during a patient procedure, the cord that deploys bands through their smartband safegrip multi-band ligation kit broke.No report of injury.

• Brand Name: SMARTBAND SAFEGRIP MULTI-BAND LIGATION KIT
• Common Device Name: LIGATOR
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 24203601
• Report Number: 1528319-2026-00004
• Device Sequence Number: 18594319
• Product Code: MND
• UDI-Device Identifier: 00724995247331
• UDI-Public: (01)00724995247331(11)240327(17)260327(10)9002784
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• 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): 01/28/2026

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 Expiration Date: 03/27/2026
• Device Model Number: SLK6LF
• Device Catalogue Number: SLK6LF
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/29/2025
• Initial Report FDA Received Date: 01/28/2026
• Date Device Manufactured: 03/27/2024
• 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