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

Model Number	C910001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device subject of this event has not been provided to steris endoscopy for evaluation.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "check to ensure that the scope is inserted completely into the scope mounting feature of the delivery housing and that the housing isn't expanded.Too tight of a fit can expand the scope mounting feature making the pushing mechanism sluggish and allow the padlock clip to get hung up on deployment, especially in retroflexion.Lesions located in the esophagus and the lesser curvature of the stomach may be difficult to treat due to endoscope articulation and positioning that is required.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." steris endoscopy has requested that the distributor offer in-service training to the user facility.No further issues have been reported.
Event or Problem Description
A user facility reported through the distributor in (b)(6) that a padlock clip defect closure system did not fully deploy, and the clip subsequently dropped from the deployment housing into the patient's stomach.The clip was immediately retrieved using a raptor grasping device and the procedure was completed successfully using a second padlock clip device.No harm to the patient or user was reported.

• 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: 9948320
• Report Number: 1528319-2020-00012
• Device Sequence Number: 2547206
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• Initial Reporter Country: MY
• PMA/510(K) Number: K180689
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/10/2020

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: 07/25/2022
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1911366
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 04/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1