Oman Ministry of Health Circular No. 10/2025
Field Safety Notice of THUNDERBEAT Type S Hand Instruments from Olympus
Source | SFDA- Saudi Food & Drug Authority |
Product | THUNDERBEA T Type S Hand Instruments. |
Manufacturer | Olympus. |
Local agent | Muscat Pharmacy & Stores LLC. |
The affected products | Model Number (Material Description; Material ID): TB-0535FCS (Thunderbeat, 5MM,35CM, Front-actuated Grip Type S; EGTB-0535FCS, N5423630, N5423730) TB-0545FCS (Thunderbeat, 5MM,45CM, Front-actuated Grip Type S; EGTB-0545FCS, N5423330, N5423430) TB-0520FCS (Thunderbeat, 5MM,20CM, Front-actuated Grip Type S; N5423930, N5424030) LOT Number: All (unexpired) Refer to the attachment for more details. |
Reason | The potential of probe tips of the THUNDERBEAT Type S Hand instrument are becoming damaged or are breaking, as well as instances of pad damage or detachment. |
Action |
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comments | Healthcare professionals are encouraged to report any adverse events Suspected to be associated with the above device or any other medical device to Department of Medical Device Control through the E-mail: vigilance-md@moh.gov.om |
Dr. Mohammed Hamdan Al Rubaie
Director General
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