FDA Adverse Event Malfunction Summary report: N

PADLOCK CLIP

MDR report key: 7652353 · Received June 29, 2018

Report

Report Number: 1528319-2018-00018
Event Type: Malfunction
Date Received: June 29, 2018
Date of Event: June 5, 2018
Report Date: June 29, 2018
Manufacturer: US ENDOSCOPY GROUP, INC.
Product Code: PKL
UDI-DI: 00816765013809
PMA / PMN Number: K120814
Product Problem: Yes
Report Source: Manufacturer report
Reporter Location: SD, US
Reporter Occupation: OTHER

Narratives

Additional Manufacturer Narrative · 1

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.

Description of Event or Problem · 1

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.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
492314	PADLOCK CLIP	ENDOSCOPIC CLIP	PKL	US ENDOSCOPY GROUP, INC.	C913131	1804311	00816765013809

Patients

Seq	Age	Sex	Outcome	Treatment
1