BiCOAG Hemostasis Probe

Brief description of the problem (reason for recall)

Olympus, the original equipment manufacturer, determined that the affected recalled models may have been manufactured without the designated amount of adhesive to the rear of the device’s ceramic tip, which may result in detachment of the ceramic tip. These products are designed to function as conventional electro-coagulation devices when supplied with current from a standard bipolar electrosurgical generator and are intended for coagulation of active bleeding lesions in the upper or lower gastrointestinal tracts during endoscopic procedures.

Advice for health professionals and distributors:

Surgical Innovations (SI) in consultation with the South African Health Product Regulatory Authority (SAHPRA) is recalling the affected lot numbers of the BiCOAG Hemostasis Probe on behalf of the manufacturer. Further use or distribution of the above products must be discontinued immediately. Urgently check your internal inventory and quarantine the affected products.

Surgical Innovations will arrange for upliftment and/or credits as applicable. If any of the recalled stock could have been transferred from your institution to another, please let that institution know or alternatively inform our company so that we can contact the institution supplied from your institution. Should you have any queries regarding this matter, please contact us on +27 (0) 11 568 9047 or email renes@surgicalinnovations.co.za

Proposed action taken and its urgency: A SAHPRA approved recall letter was distributed to all distribution points, and the recall process was initiated.

Reporting side effects

Public and healthcare professionals are encouraged to report any side effects after using a health product or after immunisation by using the Med Safety App. Your report will contribute to our monitoring of these health products.