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

Model Number	C910001
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 during a procedure to close a gastric fistula at a peg site with scar tissue.The failure to deploy is attributed to the presence of hardened scar tissue, which the clip was unable to penetrate.Following the reported event, the doctor chose to complete the procedure using a different type of clip as no further padlock clip devices were available.The doctor placed three other clips, two of which successfully engaged the tissue.The device history record of the subject device lot was reviewed and found no noted nonconformities.There have been no other complaints associated with this lot.The instructions for use include the following statements: "clipping hardened or severely fibrotic lesions to achieve hemostasis may be more difficult and may require, if possible, the removal of the avascular tissue." in-service training was completed on (b)(4) 2019.No further issues have been reported after in-service was completed.
Event or Problem Description
The user facility reported the padlock clip failed to engage tissue.The clip was released into the stomach and retrieved with a roth net.The procedure was completed with another device, and there was no report of injury.

• 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: 8310432
• Report Number: 1528319-2019-00004
• Device Sequence Number: 47075
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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): 02/06/2019

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: 09/16/2021
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1815592
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/11/2019
• Initial Report FDA Received Date: 02/06/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1