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

Model Number C913131

Device Problem Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/18/2019

Event Type  malfunction  

Manufacturer Narrative

The device subject of the reported event was returned to steris endoscopy for evaluation.Examination of the returned device found the clip to be slightly advanced on the housing with the points protruding, however the cause of the advanced position could not be determined.The device was otherwise found to be functional.The device history record was reviewed and confirmed the lot was manufactured to specification.The instructions for use include the following statements: "twist and pull the safety cap gently to remove.Caution: inspect padlock clip 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." the distributor has provided in-service training on use of the padlock clip device to the user facility on (b)(6) 2019.No further issues have been reported.

Event Description

The distributor reported that during intubation of an endoscope with a padlock clip pro select defect closure system attached, the user noted blood in the esophagus and withdrew the endoscope.Upon withdrawal of the device, the user noted the points of the clip were protruding past the deployment housing.The procedure was stopped due to the reported event and was completed at a later date with another padlock clip device.

• Brand Name: PADLOCK CLIP PRO-SELECT DEFECT CLOSURE DEVICE
• Type of Device: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer (Section G): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley rd; mentor, OH 44060 ; 4403586251
• MDR Report Key: 9492147
• MDR Text Key: 202058132
• Report Number: 1528319-2019-00045
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00816765013809
• UDI-Public: (01)00816765013809
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K180689
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 12/18/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 08/26/2022
• Device Model Number: C913131
• Device Catalogue Number: C913131
• Device Lot Number: 1912112
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 11/19/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/27/2019
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1