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

Model Number C910001

Device Problems Material Protrusion/Extrusion (2979); Activation Problem (4042)

Patient Problem No Code Available (3191)

Event Date 10/29/2019

Event Type  malfunction  

Manufacturer Narrative

The device subject of the reported event was discarded by the user facility and therefore was not available for evaluation.The device history record was reviewed and confirmed the lot was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "carefully examine the unit to verify that neither the contents not the package have been damaged in shipment and if damaged, do not use this product and contact your local product specialist or customer service representative.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.Deploy the padlock clip by using a firm and rapid thrust of the thumb actuator while holding the control handle body." the distributor was onsite and immediately provided in-service training to the user facility regarding attachment of the device to the endoscope and deployment technique.No additional issues have been reported.

Event Description

The distributor reported the clip component was not fully deployed during use of the padlock clip defect closure system, necessitating device withdrawal with the clip prongs partially protruding from the delivery housing.Scratches were detected on the esophagus however no treatment was required.The procedure was completed with a second padlock clip defect closure system.

Manufacturer Narrative

Follow up filed to correct field d1 to padlock clip defect closure system.Field d1 on previous report was erroneously filled as padlock clip pro-select defect closure device.

• Brand Name: PADLOCK CLIP DEFECT CLOSURE SYSTEM
• Type of Device: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 9382743
• MDR Text Key: 189590622
• Report Number: 1528319-2019-00041
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (y/n): N
• PMA/PMN Number: K180689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Type of Report: Initial,Followup
• Report Date: 11/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/14/2019
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1910799
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/30/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1