FDA MAUDE database analysis · Maimonides Medical Center · MSRE, summer 2024

Adverse events of two vessel-sealing devices in robotic urologic surgery

Henry M. Blair · Christopher Edwards · Ariel Schulman, MD · Jacob Khurgin, MD

Robotic vessel sealers cut and seal blood vessels in nearly every major urologic operation. On March 3rd, 2022 the FDA issued a field safety notice about two of them — SynchroSeal and Vessel Sealer Extend — warning that seals could fail when excessive tissue is caught in the jaws. A safety notice says a failure mode is possible; the FDA's adverse-event database says what has actually been reported.

urologic adverse-event reports reviewed

p = 0.025

severity difference between devices

22% / 19%

sealing / cutting issues, SynchroSeal

Status. Conducted through the Medical Student Research Experience at Maimonides in summer 2024 and presented at the Society of Urologic Robotic Surgeons Focal Therapy Conference, 2024, and at regional surgical meetings.

The question

What adverse events are reported for the SynchroSeal and Vessel Sealer Extend in urologic surgery, do the two devices differ in the severity of what is reported, and do the reports match the failure mode the FDA warned about?

How it is being done

The MAUDE database — the FDA's repository of mandatory manufacturer reports and voluntary reports from clinicians and patients — was queried for both devices across prostatectomy, nephrectomy, cystectomy, lymphadenectomy, nephroureterectomy and pyeloplasty.
Every report was read and classified twice: by severity, and by whether the event was actually related to device use — the second axis matters because a device that attracts more unrelated reports looks worse than it is.
Python scripts handled the classification and grouping of event descriptions into comparable categories.
Chi-square analysis compared severity profiles between devices, then was repeated after excluding unrelated events — the comparison that answers the clinical question.
37 SynchroSeal and 30 Vessel Sealer Extend urologic reports met criteria.

What it shows so far

SynchroSeal drew more reports overall, but a higher share of them were unrelated to device use — the raw count is misleading on its own.
After excluding unrelated events, SynchroSeal had significantly fewer severe and critical events than Vessel Sealer Extend (p = 0.025).
The characteristic SynchroSeal failures were dislodged components, jaw-cover tears and thermal damage.
Sealing issues appeared in 22% and cutting issues in 19% of urologic events — matching the failure mode the FDA's notice described, which is the finding that ties the database back to the warning.

Why the two-axis classification mattered. Ranked by raw report count, one device looks worse. Ranked by severity of events actually attributable to the device, the ordering reverses. Reporting volume is not a safety signal.

Materials

Conference poster (PDF) — passphrase

What comes next

The queries were restricted to urologic reports for time. Extending to all surgical specialties would add the statistical power this analysis lacks and test whether the severity difference holds outside urology.

This page grows as the work does.