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

Model Number	C910001
Health Effect - Clinical Code	Perforation (2001)
Date of Event	01/28/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Use of the padlock clip for tissue closure prior to polyp resection is off-label use and contrary to the information provided in the instructions for use for the padlock clip defect closure system.The event is attributed to loss of tissue compression during off-label use of the device.The padlock clip is designed for tissue closure after polyp resection.A review of past complaints has found no previous reports of device use in this manner.Us endoscopy informed the user facility of the intended use of the device and offered in-service training, however the user facility has declined.No further issues have been reported.
Event or Problem Description
The user facility reported a perforation was detected during use of the padlock clip device in a polyp resection procedure.The clip was deployed over a duodenal polyp prior to resection and the polyp was resected above the clip.The tissue separated from the clip, exposing the resection site perforation.Surgical intervention was needed, and the patient has been discharged.

• Brand Name: PADLOCK CLIP DEFECT CLOSURE DEVICE
• Common Device Name: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8398493
• Report Number: 1528319-2019-00012
• Device Sequence Number: 312987
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2019

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: 10/16/2021
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1819180
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 02/05/2019
• Initial Report FDA Received Date: 03/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1