MAUDE Adverse Event Report: UNITED STATES ENDOSCOPY GROUP, INC. PADLOCK PROSELECT CLIP

Model Number	C913131
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	12/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record was reviewed and we found no issues during manufacture; the device was manufactured to specification.We have requested the return of this padlock proselect clip for further evaluation and to-date are awaiting it's return.The instructions for use instruct the user to "deploy padlock clip by rapidly pushing the thumb actuator while holding the handle body".
Event or Problem Description
The user facility reported during a procedure the padlock proselect clip did not fully deploy into the tissue.The clip was released into the lumen of the patient's colon and then the physician retrieved the clip without issue.There was no harm to the patient or the user.
Additional Manufacturer Narrative
Follow-up # 1: in-service training has been provided to the customer.The device was returned and evaluation of the device found it to be in proper working order.No additional issues have been reported.

• Brand Name: PADLOCK PROSELECT CLIP
• Common Device Name: CLIP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7161820
• Report Number: 1528319-2018-00001
• Device Sequence Number: 1476267
• Product Code: PKL
• UDI-Device Identifier: 00816765013809
• UDI-Public: (01)00816765013809
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K120814
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Physician
• Device Expiration Date: 12/31/2019
• Device Model Number: C913131
• Device Catalogue Number: C913131
• Device Lot Number: 2016-12-16-701
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/16/2018
• Was the Report Sent to FDA?: No
• Initial Date Received by Manufacturer: 12/04/2017
• Supplement Date Received by Manufacturer: 12/04/2017
• Initial Report FDA Received Date: 01/03/2018
• Supplement Report FDA Received Date: 01/17/2018
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention