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THD SensyProbe

THD SPA · Model THD SensyProbe · UDI-DI 08033737712290

KLA Prescription

510(k) clearances

Adverse events

Recalls

Facilities

Description

THD SensyProbe is an innovative single-use probe to be used with the Anopress device to perform a THD anorectal manometry examination. THD SensyProbe allows measuring of the actual mean sphincter tone pressure in the various functional activations (resting, squeeze and strain tone). In addition, thanks to a balloon fitted at the end of the probe and connection via a dedicated line, THD SensyProbe allows analysing the rectal ampulla volume and hence assessing rectal sensitivity and anorectal inhibitory reflex (this measurement can be made after inflating the balloon with the dedicated THD SensyProbe Accessory). THD SensyProbe does not need to be calibrated, as this is automatically done each time a procedure with THD Anopress is started. The probe is equipped with an ergonomic grip and has a fully atraumatic tip ensuring maximum comfort for the medical staff and the patient during the examination, and it has been dimensioned so as to reproduce the conditions during a normal digital exploration. A Probe Card to record the examination is included in the package.

Recalls

Date	Firm	Reason
2006-04-06	Medtronic Gastroenterology / Urology	Mislabeling- The 8 ports of the manometric catheter were incorrectly labeled 1,3,5,7,8,2,4,6 from the distal to the proximal end of the catheter. The correct port configuration is

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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.