MAUDE Adverse Event Report: US ENDOSCOPY PADLOCK CLIP; PADLOCK CLIP DEFECT CLOSURE SYSTEM

Model Number	C910001
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/25/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The padlock clip defect closure system subject of the reported event is being returned for evaluation.Investigation of the event is currently in progress.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 padlock clip defect closure system did not deploy the clip.A second padlock clip was used to complete the procedure resulting in a procedure delay.No report of injury.
Additional Manufacturer Narrative
The padlock clip is used for clip placement within the gastrointestinal tract and consists of a single-use clip within a delivery system.The clip component of the device is within a delivery housing which is mounted and secured at the distal tip on the outside surface of a flexible endoscope.A linking cable rests along the outside of the endoscope's insertion tube and connects the delivery housing/clip to a control handle and thumb actuator outside of the patient.The user depresses the thumb actuator to deploy the clip.The user facility returned the device subject of the reported event to steris for evaluation.The evaluation determined that the linking cable was disconnected from the control handle and had multiple kinks.Based on the evaluation results, the reported event was likely caused by the disconnected linking cable which is part of the mechanism to deploy the clip.The damage observed to the linking cable is indicative of improper handling by user facility personnel.The instructions for use (ifu) include the following statement about proper handling of the linking cable, "avoid bending the linking cable too aggressively or using a grasping/clamping device on the linking cable as it can create a "kink" and/or disable device function." additionally, the ifu includes instructions to inspect the linking cable for kinks prior to use, specifically, "inspect the entire padlock clip defect closure system for kinks in the linking cable or other damage to the delivery housing, control handle body, and the thumb actuator (cracks, breaks, protruding or missing parts).If damage is evident do not use this product and contact your local product specialist or customer service representative." the device history record for the subject lot was reviewed and confirmed the lot was manufactured according to specifications; no abnormalities were noted.No additional issues have been reported.

• Brand Name: PADLOCK CLIP
• Common Device Name: PADLOCK CLIP DEFECT CLOSURE SYSTEM
• Manufacturer (Section D): US ENDOSCOPY; 5976 heisley road; mentor 44060
• Manufacturer (Section G): US ENDOSCOPY; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor 44060 ; 4405197842
• MDR Report Key: 22591360
• Report Number: 1528319-2025-00080
• Device Sequence Number: 8995741
• Product Code: PKL
• UDI-Device Identifier: 00724995184247
• UDI-Public: (01)00724995184247(11)240606(17)270606(10)10549785
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/24/2025

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: C910001
• Device Catalogue Number: C910001
• Device Lot Number: (10)10549785
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/25/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/06/2024
• 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