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

https://ade.sfda.gov.sa/Fsca/PublishDetails/227

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

  1. Ensure all personnel are completely knowledgeable and thoroughly trained on the content of the attachment and the relevant IFU

  2. Contact the local agent for remedial action.

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

To: