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	01/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The reported event occurred after the clip was successfully placed in the patient.Following the subject event, the patient was admitted to hospital for observation.Patient was discharged with no reported complications.The device subject of the reported event was returned to use for evaluation.Examination of the subject device shows the mounting strap was present and no apparent nonconformance of the mounting feature.The endoscope used in the procedure was confirmed to be of a size compatible with the padlock clip device subject of the reported event.Given the lack of apparent defect in the returned device and use of compatible scope, the event is likely attributed to the user technique when attaching the device to the endoscope.The instructions for use include the following statements regarding attachment of the deployment housing to the endoscope: "check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that there is no gap on the open side where the scope and distal housing meet.Grasp the securing strap and stretch it across the "c" shaped opening and secure the securing strap onto the #2 securing strap mounting hook on the far side.When the strap is in both hooks, the housing is now secured onto the scope.Carefully apply lubricant liberally to the outside of the housing." there have been no other complaints associated with this lot.Use has offered in-service training and the user facility has accepted.The training is scheduled for 2/14/2019.
Event or Problem Description
The user facility reported the deployment housing of the padlock clip device became detached from the endoscope during withdrawal of the endoscope.The deployment housing was retrieved using a rigid endoscope and the procedure was completed successfully.No report of injury.

• 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: 8318187
• Report Number: 1528319-2019-00005
• Device Sequence Number: 19267427
• Product Code: PKL
• UDI-Device Identifier: 00816765013809
• UDI-Public: (01)00816765013809
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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): 02/07/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: C913131
• Device Catalogue Number: C913131
• Device Lot Number: 1818519
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2019
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/07/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1