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

Model Number	C913131
Medical Device Problem Codes	Difficult to Remove (1528); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of the reported event was not returned to steris endoscopy for evaluation.Without the return of the device, the root cause could not be determined.The instructions for use includes the following statements, "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 no abnormalities were noted.There have been no other complaints associated with this lot.Steris offered in-service training on the proper use and operation of the padlock clip pro-select; however, the user facility declined.No additional issues have been reported.
Event or Problem Description
The user facility reported via medwatch report (b)(4) that during a patient procedure while withdrawing their scope after padlock clip deployment, the cap detached.The cap was removed from the patient.No report of injury.

• 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
• MDR Report Key: 17138031
• Report Number: 1528319-2023-00019
• Device Sequence Number: 17116926
• Product Code: PKL
• UDI-Device Identifier: 00724995184254
• UDI-Public: 00724995184254
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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): 06/15/2023

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: 4612352
• 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: 05/22/2023
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/15/2023
• Supplement Report FDA Received Date: 04/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2022
• 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