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THD SLIDE ONE

THD SPA · Model THD OPTI-FIBER (REVO/BT) · UDI-DI 08033737710777

JAF Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

The THD 880012 sterilizable flexible fibre optic cable is to be used in conjunction with the THD Slide disposable kit and the THD disposable diagnostic devices. One end of the cable has a cylindrical anodised aluminium attachment for connection to the light source of the generator (THD Evolution / THD Revolution) and other THD light sources; the other end has a curved stainless steel tip exclusively for THD anoscopes. The cable has an external silicon sheath and an internal reinforcement to prevent damaging the optical fibres. The length of the cable and its extreme flexibility allow the user to easily and comfortably use the instrument.

Recalls

Date	Firm	Reason
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2023-02-10	Unetixs Vascular, Inc.	The current luer fittings and adaptors allow for the possibility of the air line to be misconnected to an intravenous line, which may cause an air embolism.
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood
2017-06-09	Natus Neurology Inc	Some of the Elite 2 and 3 Obstetric probes and 5 MHz Vascular Probes may exhibit excessive background noise that may mask the users ability to clearly hear heart rate and/or blood

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.