09 Sep Single Use Distal Cover – Model: MAJ-2315
| Company name & Address: | Registration number | Batch number(s) | Expiry date | Pack size | First Distribution date | Re-call Classification | Recall date |
| Surgical Innovations (Pty) Ltd (SI)
Stand 208 C, Paddock Lane, Corner Epsom Avenue and Malibongwe Drive, Boundary Park, Northriding, Randburg, 2162
|
N/A | H3913
H3928 H3X26 H3X27 H3Y10 H4227 H4617 H4801 H4802 H4X08
|
Not provided | each | June 2024 | Class I, Type C | 04 September 2026 |
Brief description of the problem (reason for recall)
The MAJ-2315 is a single use detachable cap designed to cover the exposed mechanical components at the distal end of the following Duodenoscope models TJF-Q190V, TJF-Q290V, and TJF-Q170V. Olympus conducted an investigation into the Single Use Distal Covers after receiving complaints of the distal cover unexpectedly detaching from the duodenoscope during use. In the past 12 months, Olympus has received 96 complaints of the MAJ-2315 distal cover falling off within or outside patients. This included 36 events considered to be Serious Injury, which involved foreign body retrieval and/or additional treatment. To address this issue, Olympus has developed a newly designed version of the Distal Cover (MAJ2315), which contains a new attachment tool to help mitigate the risk of incorrect attachment of the distal cover to the scope.
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 Single Use Distal Cover MAJ-2315 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 stock upliftment, and replacement and/or credits to be further discussed. Refer to the below images showing the new design versus the old design.
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 paulp@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.