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

Model Number	C910001
Health Effect - Clinical Code	Laceration(s) of Esophagus (2398)
Date of Event	04/29/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Through follow-up with the user facility, us endoscopy has learned that lubricant was not applied to the device housing.Lubrication of this device prior to insertion is required and specified in the instructions for use.The device subject of the reported event was discarded by the user facility and is not available for evaluation.The device history record was reviewed and confirmed the device was manufactured to specification.There have been no other complaints associated with this lot.The instructions for use include the following statements: "carefully apply lubricant liberally to the outside of the padlock clip housing.Pass endoscope loaded with padlock clip delivery system cautiously through cricopharyngeal area of patient." us endoscopy has provided in-service training to the user facility, including instruction on proper lubrication of the device housing.No additional issues have been reported.
Event or Problem Description
The user facility reported difficulty passing the padlock defect closure device through the upper esophagus during a procedure to close a fistula.Subsequent to insertion of the device, a laceration of the esophagus was noted.An injection of epinephrine was administered to control bleeding and the fistula closure procedure was completed.

• 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: 8649819
• Report Number: 1528319-2019-00023
• Device Sequence Number: 2247440
• Product Code: PKL
• UDI-Device Identifier: 00816765013793
• UDI-Public: (01)00816765013793
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/29/2019

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: 04/01/2022
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 1905141
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/01/2019
• Initial Report FDA Received Date: 05/29/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1