Module 16 2024

Scenarios

Scenario # Device type

Event

1

Topical wound care dressing Cerebral aneurysm clip

Type I diabetic patient in Nottingham (UK) experiences a known 'skin irritation'. At a major hospital in Spain, a patient with 2x devices implanted undergoes an MRI scan 3 months after surgery. The implant card for the device incorrectly indicates that the device is MR compatible. The patient experiences a sub dural haemorrhage.

2

3

Surgical suture Manufacturer markets a suture with and without an antibacterial coating.

The manufacturer discovers that a batch of product (for distribution across the Nordic region) labelled as uncoated is in fact coated. A salesperson in Iceland receives a report of a patient (undergoing a thyroidectomy) experiencing an allergic reaction that required medical intervention. A hospital in Greece reports that a nurse in the OR suffers an electric shock when moving an external power supply of a coagulation system. A reusable device fractures during a routine general surgical procedure at a hospital in Jersey, unknown to the surgeons, a small fragment of the instrument remains inside the abdomen at the completion of the procedure. This issue was identified post-op, and second procedure was required to remove the foreign body. Numerous hospitals in France, Belgium and the Netherlands report that packets of swabs are empty when opened. Due to a shortage of supplies, a UK prison has to use Covid-19 test kits beyond their expiry date. Having tested positive, 5x patients are confined to isolation in the medical centre. Further testing (using in date kits) reveals that the original tests were false positive results, i.e., positive tests when the patients were negative. Europe. An Italian community centre reports that the seals of 3x 1L bottles of WFI are incomplete. 2x French centres report that the coated surface of the surgical mesh is contaminated with black particles. The contamination is noted before use of the mesh, and alternative devices are used, albeit with a delay in the surgery. Manufacturer supplies hospitals across

4

External power supply for a coagulation system Instrument for an orthopaedic implant

5

6

Surgical swab

7

Covid-19 test

8

Sterile water for injection (WFI)

9

Coated surgical mesh

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