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

Model Number	C913131
Medical Device Problem Code	Failure to Fire (2610)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Steris endoscopy has requested the device subject of the event to be returned for evaluation.A follow-up report will be submitted when additional information becomes available.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.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." the device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.
Event or Problem Description
The distributor reported that during a patient procedure the padlock clip pro-select defect closure system did not deploy.Facility personnel utilized a different clip to complete the procedure resulting in an approximately 20 minute delay.The procedure was completed successfully, no report of injury.
Additional Manufacturer Narrative
Us endoscopy has requested that the distributor return the device subject of the event for evaluation.To date, we have not yet received the device for evaluation.We will continue to follow-up with the distributor to determine if the device is available to be returned.A follow-up report will be submitted when additional information becomes available.
Additional Manufacturer Narrative
The device subject of the event was not returned to us endoscopy for evaluation.The distributor provided pictures and video of the device subject of the event which showed that the safety wires were no longer attached to the handle assembly and the spring sheath had kinks.The observed damage is indicative of improper handling by user facility personnel.The distributor reported that the customer does not need in-service training.No additional issues have been reported.
Additional Manufacturer Narrative
On march 7, 2024, the device subject of the event was returned to steris for evaluation.The evaluation confirmed that the control wires were disconnected from the handle assembly and the spring sheath had bends/kinks which is indicative of improper handling by user facility personnel.No additional issues have been reported.

• Brand Name: PADLOCK CLIP PRO-SELECT DEFECT CLOSURE SYSTEM
• Common Device Name: 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: 17246448
• Report Number: 1528319-2023-00024
• Device Sequence Number: 20510316
• Product Code: PKL
• UDI-Device Identifier: 00724995184254
• UDI-Public: 00724995184254
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date (Section B): 07/03/2023

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: 2200041
• 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: 06/19/2023
• Supplement Date Received by Manufacturer: 06/19/2023; 06/19/2023; 06/19/2023; Not provided
• Initial Report FDA Received Date: 07/03/2023
• Supplement Report FDA Received Date: 08/23/2023; 10/20/2023; 03/13/2024; 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/04/2022
• 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