Device product
US Endoscopy Padlock Clip defect closure system Ref: C910001 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.
Z-1011-2019
Product summary
- Event
- Event 82142
- Status
- Terminated
- Classification
- Class II
- Quantity
- 483 units ( 325 units US and 158 OUS)
- Official record key
device-enforcement:Z-1011-2019
Official wording
Reason: Potential esophageal laceration during a patient procedure
Code information: Lot Numbers: 1814568, 1814569, 1815200, 1815592, 1816056, 1817174, 1817810, 1818187, 1818596, 1819180, 1819181, 1819407, 1819793, and 1820177.
Distribution pattern: Worldwide Distribution: US (Nationwide) and countries of: Australia, Belgium, Czech Republic, Germany, Great Britain, India, Italy, Lebanon, Mexico, Netherlands, Norway, Philippines, S. Korea, Spain, Sweden and United Arab Emirates.
Derived failure modes
-
Unknown
Potential esophageal laceration during a patient procedure