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THD SLIDE ONE

THD SPA · Model THD SLIDE · UDI-DI 08033737710869

JAF Prescription

510(k) clearances

Adverse events (4 deaths)

Recalls

Facilities

Description

The THD Slide proctoscope includes a handle and an anatomically shaped sliding part to be inserted transanally in the rectum during the surgical procedure. The handle is shaped so that the tip of the THD Fiber Optic Cable can be inserted. A slot on the sliding part accommodates the Doppler transducer (THD Doppler Probe). The upper portion of the proctoscope includes a window to access the surgical area: this characteristic permits the physician to slide this part during the operation and to position the window correctly for the artery ligation. The movement of the upper part of THD Slide proctoscope allows the physician to obtain a wide surgical window that can be moved in the rectum to facilitate the ligation of the artery and to perform a pexy to reduce the prolapse. The THD Slide device pack includes also a know tightner that facilitate the closure of the knot carried out with the surgical suture. This instrument allows the surgeon to push the knot towards the anal mucosa, avoiding that the surgeon should use his finger to perform this operation. The knot-tightener features a tiny groove for tightening the knot. THD Slide is individually packed and EO sterilized.

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.