MAUDE Adverse Event Report: US ENDOSCOPY GROUP, INC. PADLOCK CLIP; ENDOSCOPIC CLIP

Model Number	C913131
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/05/2018
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 device was not returned to us endoscopy 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 state: carefully examine unit to verify that neither the contents nor the package has been damaged in shipment and if damage is evident, do not use this product and contact your local product specialist or customer service representative.Deploy padlock clip by rapidly pushing the thumb actuator while holding the handle body.In-service training was completed immediately following the event.There have been no further reports of partial deployment.
Event or Problem Description
The user facility reported that a padlock clip failed to fully deploy during procedural use.The device was removed from the patient with the tips of the clip component protruding from the delivery system housing.There was no report of harm to the patient or user and the procedure was completed with a second padlock clip device.

• Brand Name: PADLOCK CLIP
• Common Device Name: ENDOSCOPIC CLIP
• Manufacturer (Section D): US ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• MDR Report Key: 7652353
• Report Number: 1528319-2018-00018
• Device Sequence Number: 14082244
• Product Code: PKL
• UDI-Device Identifier: 00816765013809
• UDI-Public: (01)00816765013809
• Combination Product (Y/N): N
• Initial Reporter State: SD
• 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
• Report Date (Section B): 06/29/2018

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: 03/13/2021
• Device Model Number: C913131
• Device Catalogue Number: C913131
• Device Lot Number: 1804311
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/05/2018
• Initial Report FDA Received Date: 06/29/2018
• Patient Sequence Number: 1