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

Model Number	C913131
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The padlock device subject of the event was returned to us endoscopy for evaluation.The returned device was received in a partially deployed state indicating insufficient deployment force.Insufficient force may be caused by insufficient application of force by the user or use of the device in an overly tortuous position.Statements from the device instructions for use include: "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 devices were manufactured to specification.There have been no other complaints associated with this lot.Us endoscopy has provided in-service training on the use and deployment of the padlock clip device on (b)(6) 2019.No additional issues have been reported.
Event or Problem Description
The user facility reported that, during a procedure to close an esophageal fistula, a padlock pro-select defect closure device failed to deploy.A covered stent was placed to close the fistula instead, necessitating a future procedure to remove said stent.The patient is reported to be doing well.

• Brand Name: PADLOCK CLIP PRO SELECT DEFECT CLOSURE SYSTEM
• Common Device Name: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8520706
• Report Number: 1528319-2019-00018
• Device Sequence Number: 19429184
• Product Code: PKL
• UDI-Device Identifier: 00816765013809
• UDI-Public: (01)00816765013809
• Combination Product (Y/N): N
• Initial Reporter State: LA
• Initial Reporter Country: US
• PMA/510(K) Number: K180689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/16/2019

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 Expiration Date: 01/25/2022
• Device Model Number: C913131
• Device Catalogue Number: C913131
• Device Lot Number: 1901228
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 03/18/2019
• Initial Report FDA Received Date: 04/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1