Starting from 1 January 2022, active safety alerts related to medical devices listed under MDACS are listed below. For safety alerts before 1 January 2022, please refer to archive.
The United Kingdom Medicines and Healthcare products Regulatory Agency (MHRA) has posted a medical device safety alert concerning Caiman Maryland Non Articulat.D5/360mm/ (Pl770SU), Caiman Maryland Articulating D5/360MM/ (PL771SU), Caiman Maryland Non Articulat.D5/125MM/ (PL774SU), Caiman Maryland Non Articulat.D5/170mm/ (PL775SU) [UDI-DI: 40392390000012752F; Part number(s): PL770SU, PL771SU, PL774SU, PL775SU; Affected serial or lot: 52781985, 52793444, 52798113, 52800364, 52802809, 52803165, 52803332, 52803886, 52805370] [HKMD No.: 190199].
According to the MHRA, after implementation of the design change in production a functional deviation related to the spring has been internally detected. The functional deviation may be that the spring becomes loose, displaced and may fall out of the jaw housing. If the spring falls out during use, the functionality of the device itself is still given and it is possible that the user will not notice the defect that the spring may have fallen into the patient’s body. Based on the relatively small size of the spring (3mm) it is also unlikely that the user would recognize the missing spring after finalizing the laparoscopic procedure. The remaining spring inside the patient’s body may cause a foreign body reaction, such as immune response, inflammation or pain and could result in a revision surgery.
For further information, please visit https://mhra-gov.filecamp.com/s/d/TBENzsf2MXBWCZiR
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 17 Mar 2023