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

Model Number C913131

Device Problems Positioning Failure (1158); Material Protrusion/Extrusion (2979)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 06/05/2018

Event Type  malfunction  

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 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
• Type of Device: ENDOSCOPIC CLIP
• Manufacturer (Section D): US ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer (Section G): US ENDOSCOPY GROUP, INC.; 5976 heisley road; mentor OH 44060
• Manufacturer Contact: coletta cohara ; 5976 heisley road; mentor, OH 44060 ; 4403586251
• MDR Report Key: 7652353
• MDR Text Key: 113163215
• Report Number: 1528319-2018-00018
• Device Sequence Number: 1
• Product Code: PKL
• UDI-Device Identifier: 00816765013809
• UDI-Public: (01)00816765013809
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K120814
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 06/05/2018
• Initial Date FDA Received: 06/29/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/13/2018
• Is the Device Single Use?: Yes
• Type of Device Usage: N
• Patient Sequence Number: 1