FCA Notification - Olympus Forceps/Irrigation Plug (Isolated Type) MAJ-891 : Reprocessing Recommendations for Forceps/Irrigation Plug (Isolated Type) MAJ-891

 

Affected Medical Device : Forceps/irrigation plug

 

MDA Reference Number : MDA/FCA/2021-P117

 

MDA Registration Number : GB3798579516

Decription : To remind of important reprocessing instructions for the Forceps/Irrigation Plug (Isolated Type) model MAJ-891 (“MAJ-891”). Improper and/or incomplete reprocessing can present an infection control risk. Accordingly, it is important to closely follow the instructions for use for reprocessing the MAJ-891, including disassembling the MAJ-891 as instructed.

 

Local Establishment Contact Detail :

Shelly Yeoh
Assistant Manager, Regulatory Affairs | Medical Systems Business Division | Olympus (Malaysia) Sdn. Bhd.
TEL: (603) 7886 9188 | FAX: (603) 7887 2833 |

Email : seoching.yeoh@olympus-ap.com

 

 A copy of FSN.