Device product
LigaSure Blunt Tip Laparoscopic Sealer/Divider, Nano-Coated, Product Number LF1837
Z-0495-2022
Product summary
- Firm
- Covidien Llc
- Event
- Event 89182
- Status
- Terminated
- Classification
- Class II
- Quantity
- 504 devices
- Official record key
device-enforcement:Z-0495-2022
Official wording
Reason: Customers reported that the device jaws were difficult to open or would not open following application on tissue. Use of a device with this potential assembly issue could result in the potential for bleeding, unintended tissue injury or loss, and delay in treatment while an alternate device is obtained.
Code information: UDI: 20884521705880 10884521705883; Lot Number: 11320187X
Distribution pattern: Worldwide Distribution in the countries of Australia, Austria, Belgium, Czech Republic, France, Germany, Ireland, Kazakhstan, Netherlands, Spain, United Kingdom. No US distribution.
Derived failure modes
-
Manufacturing or process control
assembly issue