Device product
Brand Name: MST Duet Reusable Handle for Single Use Heads Product Name: Reusable Handle for Single Use Heads (Forceps and Scissors) Model/Catalog Number: DFH-1028 Software Version: N/A Product Description: A MST Single Use Forceps or Scissors System consists of a reusable handle and one of a number of single use interchangeable heads. MST Single Use Forceps and Scissor heads are shipped ready to use sterile in a tray with Tyvek lid within a sterile pouch. MST Duet Reusable Handle for Single Use Forceps & Scissor Heads are supplied in a non-sterile condition and must be sterilized prior to and after every use. The blue sleeve the handle is packaged in is not intended to be sterilized and does not maintain sterility. Component: Yes. The MST Duet¿ Reusable Handle for Single Use Heads is the reusable handle component which connect to either Single Use Forceps or Scissors heads.
Z-0521-2025
Product summary
- Event
- Event 95572
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 24
- Official record key
device-enforcement:Z-0521-2025
Official wording
Reason: Due to pin coming off of handles.
Code information: Lot Code: Product Codes: HNF or HNR (Regulation Number 886.4350). Either code can apply as the Duet Handle Assembly can be used with MST Duet Ophthalmic Scissors or MST Duet Forceps. UDI: 00844685005536 Lot #: 160458. Lot number is a sequential number generated through the internal SAP. All finished goods can be effectively traced by the lot number as either the finished good part or the sub part used. Expected life: The number of handle reprocessing cycles is not limited as long as the post-cleaning and pre-use inspections determine that the product is still functional and shows no signs of damage or corrosion.
Distribution pattern: U.S.: CT, GA, MN, MT and TX. O.U.S.: Netherlands 24 total devices = 6 devices distributed in the United States and 18 devices distributed in Germany.
Derived failure modes
-
Unknown
Due to pin coming off of handles.