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

Model Number	C910001
Health Effect - Clinical Code	Injury (2348)
Date of Event	05/25/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Contrary to the instructions for use, the user did not inspect the clip position within the housing prior to use and the deployment handle stay was removed prior to intubation.Statements in the instructions for use include: "twist and pull the safety cap gently to remove.Caution: inspect clip delivery housing closely, and circumferentially, to make sure that none of the clip's points extend beyond the distal rim/edge.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." examination of the device subject of the reported event confirmed the clip to be advanced on the housing, and found the device to be otherwise functional.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.A us endoscopy representative advised the user facility regarding use of the padlock defect closure device, including checking the position of the clip points prior to intubation and maintaining the handle stay until ready to deploy.No additional issues have been reported.
Event or Problem Description
The user facility reported that during intubation of an endoscope with a padlock clip defect closure system attached, the user was unable to advance past the upper esophageal sphincter.Upon withdrawal of the device, the user noted the points of the clip were protruding past the deployment housing.The user reported local trauma to the patient's oropharynx with no treatment required and the procedure was completed with another padlock device.

• Brand Name: PADLOCK CLIP DEFECT CLOSURE SYSTEM
• Common Device Name: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor, oh
• MDR Report Key: 10200759
• Report Number: 1528319-2020-00020
• Device Sequence Number: 16674364
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• 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,user faci
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/26/2020

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: 12/01/2022
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1916345
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2020
• Initial Report FDA Received Date: 06/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1