Device product
Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F
Z-1020-2019
Product summary
- Firm
- Covidien, PLC
- Event
- Event 82244
- Status
- Terminated
- Classification
- Class II
- Quantity
- 850 units
- Official record key
device-enforcement:Z-1020-2019
Official wording
Reason: Potential for the sterile packaging to be compromised
Code information: Lot Number: 80390309X UDI-Device Identifier (GTIN/UPN) 10884524000084/ 20884524000081
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Sterility assurance
sterile packaging to be compromised