MAUDE Adverse Event Report: US ENDOSCOPY HISTOLOCK; RESECTION DEVICE

Model Number	00711177
Medical Device Problem Code	Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/23/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not returned for evaluation.Without the return of the device, an evaluation could not be completed, and the cause of the reported event could not be determined.The histolock resction device ifu states, "thin snare wires may unintentionally cut prior to good electrocoagulation.The following conditions may not allow the device to function properly or cause patient injury: attempting to advance the handle to the open position with too much speed or force, attempting to pass or open the device in an extremely articulated endoscope, attempting to actuate the device in an extremely coiled position and/or, attempting to actuate the device when the handle is at an acute angle in relation to the sheath.If resistance to insertion is encountered, reduce the angulation (or lower the forceps elevator if applicable) until the instrument passes smoothly.Read the entire instructions for use, inspect and familiarize yourself with the device.If there is evidence of damage, (e.G.Deformed or bent snare, inoperable handle, or damaged packaging) do not use this product, save the packaging and device, and contact your local product specialist." the device history record was reviewed and confirmed the lot subject of the event was manufactured to specifications; no abnormalities were noted.A complaint review was performed and confirmed the reported event to be isolated for the subject lot.As the user facility's contact information was blank in the received medwatch, steris was unable to obtain additional information regarding the report event.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch #5184607 that during a patient procedure the snare to their histolock resection device protruded outside of the plastic sheath.The procedure was completed successfully after the snare was fed back into the sheath and the polyp was released.No report of injury.

• Brand Name: HISTOLOCK
• Common Device Name: RESECTION DEVICE
• 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 ; 4402597401
• MDR Report Key: 25056261
• Report Number: 1528319-2026-00043
• Device Sequence Number: 13111532
• Product Code: FDI
• UDI-Device Identifier: 00724995182625
• UDI-Public: (01)00724995182625(11)251118(17)281118(10)13128556
• Combination Product (Y/N): N
• 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): 05/01/2026

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: 00711177
• Device Catalogue Number: 00711177
• Device Lot Number: (10)13128556
• 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: 04/03/2026
• Initial Report FDA Received Date: 05/01/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/18/2025
• 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