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

Model Number	C910001
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/24/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
After the devices failed to deploy the clips inside the patient, the physician was able to successfully deploy the clips into a towel outside the patient.Review of the device history records found no issue during the manufacture of either device; the devices were manufactured to specification.The instructions for use instruct the user to, "deploy padlock clip by rapidly pushing the thumb actuator while holding the handle body." the padlock clip device is compatible with endoscopes with an outer diameter between 9.5mm and 14mm.The endoscope in use during to procedure had a diameter outside this range.In-service training will be provided to the customer.Not returned to manufacturer.
Event or Problem Description
The user facility reported during a hemostasis procedure two padlock clips failed to deploy.The patient was subsequently sent to interventional radiology to complete the procedure and was discharged the same day.

• Brand Name: PADLOCK CLIP
• Common Device Name: HEMOSTATIC CLIP
• Manufacturer (Section D): UNITED STATES ENDOSCOPY GROUP, INC.; 5976 heisley rd; mentor OH 44060
• MDR Report Key: 7075905
• Report Number: 1528319-2017-00034
• Device Sequence Number: 11080748
• 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: 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): 12/01/2017

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: No Information
• Device Model Number: C910001
• Device Catalogue Number: C910001
• Device Lot Number: 2016040770 & 2016083070
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/03/2017
• Initial Report FDA Received Date: 12/01/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention