* Medical Device Safety Tips highlight what can go wrong if labeling is overlooked or not followed, and provide advice on how to mitigate risks. Commonly known as Instruction for Use manuals or package inserts, labeling includes any written material from the manufacturer accompanying medical devices. FDA’s goal is to promote awareness of labeling to enhance device safety and prevent patient harm.
What is the problem?
FDA received a report about three AVM Micro Clips that were accidentally implanted in a patient prior to being sterilized. The patient was placed on prophylactic IV antibiotics after the error was discovered and was to be scheduled for an imaging study at 6-months post-op to rule out infection.
The surgeon elected to use the AVM Micro Clips because its size was compatible with the very small vessel he was clipping, however, this particular size and style of clip was not often used at this facility. The clip typically used, also manufactured by Aesculap, is supplied sterile. Although the packaging for both of these clips is similar, there is text and a symbol noting that the AVM Micro Clip is non-sterile.
How are these devices used?
AVM Micro Clips, made by Aesculap, are microneurosurgical clips used for temporary or permanent occlusion of small vessels during surgery for intracranial arteriovenous malformation (AVM).
What can I do to prevent patient injuries?
- Be aware that some devices within the same manufacturer’s product line may be sold sterile while others are not (for example, Aesculap AVM Micro Clips that have always been supplied non-sterile must be sterilized prior to use, while Aesculap Yasargil Aneurysm clips have always been supplied sterile). Facilities should consult the product insert supplied with the device for sterilization methods and follow instructions accordingly.
- To help distinguish non-sterile from sterile products in your facility’s inventory, consider placing non-sterile products in a separate location from sterile ones.
How can I report problems to FDA?
If you suspect a problem with a medical device, we encourage you to file a voluntary report through MedWatch, the FDA Safety Information and Adverse Event Reporting program. Healthcare personnel employed by facilities that are subject to FDA's user facility reporting requirements should follow the reporting procedures established by their facilities