Module 16 2024

Scenario # Device type

Event

10

Reusable surgical instrument

A reusable laparoscopic instrument is not processed (washed/disinfected/sterilised) in accordance with the IFU provided with the device. 2x patients treated in a Norwegian hospital develop a post-surgical infection requiring further medical intervention. The device is approved for the same intended purpose in the EU and US. The devices are the same, although the pump unit of the device is sourced from 3 different suppliers in China.

11

Negative pressure wound therapy devices

<10 US patients using this 'home use' device report that their pumps stop working.

To date there have been no such events reported in the EU.

12

MIS heart valve Deaths are reported for 2 patients (1x US and 1x France) who receive a particular sized heart value (from a range of 5 sized valves) supplied by the manufacturer.

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