Reportable Event for a Medical Device? Opinions welcomed.

[Jkc3usc12]

A medical device that pulls samples ( tissue ) samples to be sent away for diagnosis. A complaint comes in that tissue ends up in not the designed place. Or tissue is found in the device when it is sent back for investigation. Lost tissue sample could result in inability to make correct diagnosis.

Thoughts on being reportable?

 

[shimonv]

Honestly, I think it's unwise to use the cove in MDR decision making process.

 

[Jkc3usc12]

I am not using the cove for an answer. I am throwing this out for any others that may have device that is used to acquire a sample for diagnosis.

 

[ScottK]

I don't think you could ever post enough information for the cove to really be able to advise on this - you'd need to share the entire history of the product.

So read below and do the risk analysis of how likely it is to cause a death or serious injury.

"Manufacturers: Manufacturers are required to report to the FDA when they learn that any of their devices may have caused or contributed to a death or serious injury. Manufacturers must also report to the FDA when they become aware that their device has malfunctioned and would be likely to cause or contribute to a death or serious injury if the malfunction were to recur. "
Medical Device Reporting (MDR): How to Report Medical Device Problems

 

[Parul Chansoria]

Seems to be reportable, nonetheless, further facts and details are needed to be sure about it, for example, the clinical condition involved in this case, etc. Further, seems like one of the following could be used

• Mandatory reporting - if already caused or contributed, or may if this malfunction were to recur, and result in death or serious injury.
• Voluntary reporting - when not sure, or root cause is not determined, or not sure of the risk in this case. According to “The Voluntary Malfunction Summary Reporting (VMSR)”, the manufacturer can do voluntary reporting in a summary form on a quarterly basis.