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

Model Number	C910001
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	11/19/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The padlock clip is indicated for use in flexible endoscopy and for the compression of tissue in the gastrointestinal tract, for hemostasis or for treating lesions of the wall of the gastrointestinal organs.The user facility reported that multiple attempts and significant force were required to deploy the clip.The endoscope used in this procedure had a tip diameter of 9.2mm, which is smaller than the minimum compatible size specified in the device instructions for use.The ifu states that the padlock clip defect closure device is compatible with flexible endoscopes with distal tip diameters ranging from 9.5mm to 11mm.The patient presented with heavy bleeding, and the physician did not believe bleeding was controlled after clip placement.Patient was sent to interventional radiology and four coils were placed to control bleeding.The patient was admitted to the intensive care unit.The user facility has declined to provide further information regarding the current status of the patient.In-service training was completed on 12/19/2018, including instruction on compatible scope sizes.No further issues have been reported after in-service was completed.
Event or Problem Description
The user facility reported difficulty while attempting to deploy the clip component of the padlock device during a hemostasis procedure.The clip was deployed on the third attempt; however, the physician did not believe bleeding was controlled after clip placement and the patient was sent to interventional radiology for further treatment.Through follow up, us endoscopy learned the endoscope used in this procedure was not compatible with the padlock clip device.

• Brand Name: PADLOCK CLIP DEFECT CLOSURE DEVICE
• Common Device Name: DEFECT CLOSURE DEVICE
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 8219054
• Report Number: 1528319-2019-00001
• Device Sequence Number: 18889442
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• Initial Reporter State: AL
• 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): 01/04/2019

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: 07/08/2021
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1811797
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 12/05/2018
• Initial Report FDA Received Date: 01/04/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1