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

Model Number	C910001
Health Effect - Clinical Code	Laceration(s) (1946)
Date of Event	01/09/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Reference user facility medwatch report #(b)(4).The reported event occurred during a procedure to close a fistula at a percutaneous endoscopic gastrostomy (peg) site and included four endoscopic insertions and withdrawals.The presence of blood in the esophagus was initially noted during the second endoscopic withdrawal.Following the reported event, the doctor chose to complete the procedure using a different type of clip at the peg site.The patient was sent for ct scan following procedure, was admitted to hospital for observation and has since been discharged.The device subject of the reported event was returned to us endoscopy for evaluation.Upon inspection of the returned device, us endoscopy identified that a small piece of the plastic housing on the delivery system was not properly seated/flush.If not flush, this could result in a laceration to the surrounding tissue during withdrawal of the endoscope.We cannot isolate the extent of affected units and therefore are initiating a recall.This recall will be completed and monitored under us endoscopy field correction #1528319-02/01/19-r-001.
Event or Problem Description
The user facility reported an esophageal laceration occurred during a procedure in which our padlock clip defect closure system was one of the medical devices utilized.The procedure was successfully completed with another device, and the patient was admitted to hospital for observation and has since been discharged.

• 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: 8323666
• Report Number: 1528319-2019-00009
• Device Sequence Number: 13987778
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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
• Remedial Action: Recall
• Type of Report: Initial
• Report Date (Section B): 02/08/2019

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: 12/09/2021
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1820177
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 01/09/2019
• Initial Report FDA Received Date: 02/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: 1528319-02/01/19-R-001
• Patient Sequence Number: 1