Having been involved before with some rather profound MDR reporting litigation, I can tell you that this topic is not always black and white. And without knowing more about the nature of the "error" your firm made, I suspect that this scenario may qualify as an 803.3 "malfunction". Specifically, based off of the liberal intent in that definition regarding failure to meet the product claims (I.e. the promises that your company has made to the customer about being able to complete the implantation without the complications associated with the error you mention).
On that line of thought, a United States threshold for having to submit an MDR report to the FDA is iif the device has malfunctioned and the device or a similar device that you market would be likely (more likely than not) to cause or contribute to a death or serious injury if the malfunction were to recur. I would say that unplanned, extended, or redundant administration of general anesthesia may reasonably meet the definition of "serious injury" because such a medical state intrinsically requires medical intervention to avoid permanent impairment or damage. In other words, if the next time around the patient made it to the general anesthesia stage or implantation stage before the procedure was aborted, then the subsequent procedure to complete the implantation wood mean that either the aborted or the subsequent procedure would intrinsically be unplanned, extended, or redundant.
And I think an analogous rationale is reasonably appropriate regarding the EU MDR's definitions of "incident" and "serious incident".
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Kevin Randall, ASQ CQA, RAC (U.S., Europe, Canada)
Principal Consultant
Ridgway, CO
United States
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Original Message:
Sent: 04-Aug-2023 03:03
From: Anonymous Member
Subject: Is planned surgery a "serious injury"?
This message was posted by a user wishing to remain anonymous
Hello,
I'm evaluating a recent event where due to an error on my company's behalf an implant device could not be placed as planned. Luckily in this case the error was identified before the patient had received anesthesia and outcome was only disappointment and postponed surgery date. However, as this could lead to the patient having unnecessary surgery if this had been discovered later the patient would be exposed to harm in the form of an additional surgical procedure requiring general anesthesia. The condition of the patient remains the same and this type of surgery is not urgent, the patient had been waiting over a year in the current condition.
Regarding reportability of this event I am now doubting whether a planned additional surgical procedure constitutes and "illness or injury" per 21 CF 803.3 or a "Serious deterioration in ...health" from MDR Art 2 (58)?
Although the event does cause an additional medical internvention including hospitalization, this intervention is not needed due to any new illness, injury or serious deterioration caused by the error, since the patient remains in the same condition. How would you argue in this situation and do you think there is a difference between the FDA and EU regulations for this event?
Following the guidance to report when in doubt we have reported the event but I wanted to see if you can help me clear this doubt.
Thanks in advance!