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

Model Number	C913131
Health Effect - Clinical Code	No Code Available (3191)
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A us endoscopy clinical specialist discussed the event with the user.The user attributed the reported event to their technique when placing clips in the affected portion of patient anatomy.No malfunction of the subject device was alleged.The user did not retain the padlock clip device subject of the reported event for evaluation.The user facility was not able to provide the lot number of the padlock clip subject of this event.The instructions for use include the following statements: "perform initial surveillance endoscopy to uncover any anatomical concerns and location of defect to be treated prior to using the padlock clip defect closure system." a us endoscopy clinical specialist has provided in-service to the user, including recommendations concerning tissue gathering technique.No additional issues have been reported.
Event or Problem Description
During a procedure to close a defect in the sigmoid colon, the user inadvertently gathered too much tissue when positioning a clip device not manufactured by us endoscopy, which restricted the sigmoid colon.The first clip device was removed, and the user continued the procedure with the us endoscopy padlock clip device and again inadvertently gathered too much tissue into the clip and restricted the sigmoid colon.Surgical intervention was then required to remove the padlock clip and close the defect.

• Brand Name: PADLOCK CLIP PRO-SELECT 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: 8754867
• Report Number: 1528319-2019-00025
• Device Sequence Number: 2280711
• Product Code: PKL
• UDI-Device Identifier: 00816765013809
• UDI-Public: (01)00816765013809
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K180689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/02/2019

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 Model Number: C913131
• Device Catalogue Number: C913131
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/04/2019
• Initial Report FDA Received Date: 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1