FDA Adverse Event Injury Summary report: N

ENVISIO SYSTEM

MDR report key: 22181430 · Received June 10, 2025

Report

Report Number: 3014653199-2025-00003
Event Type: Injury
Date Received: June 10, 2025
Date of Event: May 14, 2025
Report Date: June 10, 2025
Manufacturer: ELUCENT MEDICAL, INC.
Product Code: NEU
UDI-DI: 00851674008034
PMA / PMN Number: K183400
Adverse Event: Yes
Report Source: Manufacturer report
Reporter Location: MN, US
Reporter Occupation: 003

Narratives

Additional Manufacturer Narrative · 0

THE SYSTEM WAS USED TO LOCALIZE AND GUIDE EXCISION OF A LESION MARKED WITH THREE CLIPS. IMAGING PERFORMED AFTER PLACEMENT SHOWED THAT THE CLIPS WERE POSITIONED OUTSIDE THE LESION. DURING SURGERY, TWO CLIPS WERE BRACKETED AND USED TO GUIDE TISSUE EXCISION. ONLY ONE CLIP WAS RECOVERED IN THE SPECIMEN, AND THE TARGET LESION WAS NOT PRESENT. A SECOND SURGICAL PROCEDURE WAS REQUIRED TO REMOVE THE REMAINING CLIPS AND EXCISE THE LESION. A REVIEW OF THE CASE LOGS CONFIRMED THAT THE SYSTEM PERFORMED AS INTENDED, ACCURATELY GUIDING REMOVAL OF THE TARGETED CLIP. BECAUSE THE CLIPS WERE LOCATED OUTSIDE THE LESION, THE SECOND AND THIRD CLIPS WERE NOT SUBSEQUENTLY SELECTED FOR NAVIGATION.

Description of Event or Problem · 0

THREE CLIPS WERE IMPLANTED TO LOCALIZE A TARGET. POST-IMPLANT IMAGING REVEALED ALL THREE CLIPS TO BE POSITIONED OUTSIDE OF THE LESION. DURING THE SUBSEQUENT SURGICAL PROCEDURE, TWO CLIPS WERE BRACKETED TO GUIDE TISSUE EXCISION. UPON REMOVAL OF THE LOCALIZED SPECIMEN, ONLY ONE CLIP WAS CONFIRMED WITHIN THE EXCISED TISSUE. THE REMAINING TWO CLIPS WERE NOT RETRIEVED, NECESSITATING A SECOND SURGICAL EXCISION TO LOCATE AND REMOVE THE RESIDUAL MARKERS AND THE TARGET LESION.

Devices

Seq	Brand	Generic	Product Code	Manufacturer	Model	Lot	UDI-DI
95247	ENVISIO SYSTEM	ENVISIO	NEU	ELUCENT MEDICAL, INC.	ENVISIO-SYS		00851674008034

Patients

Seq	Age	Sex	Outcome	Treatment
1	NA	Female	Required Intervention