Totally endoscopic ear surgery is a novel method of conducting otological surgery. Hierarchical task analysis and the systematic human error reduction and prediction approach (‘SHERPA’) are valuable tools that can effectively deconstruct the technical and non-technical skills required to successfully complete a surgical procedure.

Twenty-five endoscopic tragal cartilage tympanoplasties were observed, to identify the tasks and subtasks required for completion of totally endoscopic tragal cartilage tympanoplasty. The systematic human error reduction and prediction approach was used to identify the potential risks and methods, to reduce or remediate these risks.

A hierarchical task analysis was performed, identifying 8 tasks and 50 subtasks for a safe approach to completing totally endoscopic tragal cartilage tympanoplasty. A risk score for each subtask was calculated to produce a systematic human error reduction and prediction approach and to highlight potential errors.

This hierarchical task analysis allowed for quick reference to a correct method of endoscopic tympanoplasty. The systematic human error reduction and prediction approach was employed to reduce the risks associated with undergoing endoscopic tympanoplasty, to improve patient safety.

The aim of this study was to describe previously unrecognised or under-recognised adverse events associated with Melody® valve implantation.

In rare diseases and conditions, it is typically not feasible to conduct large-scale safety trials before drug or device approval. Therefore, post-market surveillance mechanisms are necessary to detect rare but potentially serious adverse events.

We reviewed the United States Food and Drug Administration’s Manufacturer and User Facility Device Experience (MAUDE) database and conducted a structured literature review to evaluate adverse events associated with on- and off-label Melody® valve implantation. Adverse events were compared with those described in the prospective Investigational Device Exemption and Post-Market Approval Melody® transcatheter pulmonary valve trials.

We identified 631 adverse events associated with “on-label” Melody® valve implants and 84 adverse events associated with “off-label” implants. The most frequent “on-label” adverse events were similar to those described in the prospective trials including stent fracture (n=210) and endocarditis (n=104). Previously unrecognised or under-recognised adverse events included stent fragment embolisation (n=5), device erosion (n=4), immediate post-implant severe valvar insufficiency (n=2), and late coronary compression (n=2 cases at 5 days and 3 months after implantation). Under-recognised adverse events associated with off-label implantation included early valve failure due to insufficiency when implanted in the tricuspid position (n=7) and embolisation with percutaneous implantation in the mitral position (n=5).

Post-market passive surveillance does not demonstrate a high frequency of previously unrecognised serious adverse events with “on-label” Melody® valve implantation. Further study is needed to evaluate safety of “off-label” uses.