MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. PADLOCK CLIP PRO-SELECT

Model Number	C913131
Medical Device Problem Codes	Failure to Fire (2610); Activation, Positioning or Separation Problem (2906); Positioning Problem (3009)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The user facility reported that during a procedure the padlock clip pro-select did not fully deploy into the tissue.The clip was released into the lumen of the patient and was then retrieved without issue.There was no report of injury, and the procedure was completed with a second padlock clip pro-select device.
Additional Manufacturer Narrative
The device subject of the event was returned to steris endoscopy for evaluation.The returned device was found to have a significant kink at both the distal and proximal ends of the device.The kink may be caused by over articulation and insufficient application of force by the facility personnel.The padlock clip pro-select instructions for use states: "check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that the housing isn't expanded.Too tight of a fit can expand the scope mounting feature making the pushing mechanism sluggish and allow the padlock clip® to get hung up on deployment, especially in retroflexion.If any clip points extend beyond distal rim/edge, carefully replace safety cap, do not use this product, contact your local product specialist or customer service representative, and use a different device for procedure.Do not remove the handle stay until endoscope with loaded padlock clip® defect closure system is in position over defect and ready for deployment.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.Deploy padlock clip® by using a firm and rapid thrust of the thumb actuator while holding the control handle body.Once the handle stay is removed, keep hands and fingers clear from the delivery housing distal tip so that an accidental release of the padlock clip® does not result in personal injury.Once the handle stay is removed, use caution in handling thumb actuator button to prevent inadvertent deployment of the clip.When using suction to pull target tissue into the cap, there is a risk of capturing tissue/organs outside of the lumen and adjacent to the target treatment area.Use of a grasping device is recommended to acquire the target tissue and minimize the risk of capturing tissue/ organs adjacent to the treatment area." the device history record was reviewed and confirmed the devices were manufactured to specification.There have been no other complaints associated with this lot.The territory manager offered in-service training on the use and deployment of the padlock clip device; however, the user facility declined.No additional issues have been reported.

• Brand Name: PADLOCK CLIP PRO-SELECT
• Common Device Name: PADLOCK CLIP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 19617712
• Report Number: 1528319-2024-00050
• Device Sequence Number: 15194321
• Product Code: PKL
• UDI-Device Identifier: 00724995184254
• UDI-Public: 00724995184254
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 06/26/2024

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: C913131
• Device Catalogue Number: C913131
• Device Lot Number: 9284068
• 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: 05/29/2024
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/09/2024
• 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