Valleylab E2783R-28ASPRecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 10884524000725), received between Nov 27, 2017 and Nov 27, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Unstable” (1 report).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2017Unstable; Unstable

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE PHYSICIAN WAS ATTEMPTING TO RETRACT THE L-HOOK WHILE THE DISTAL END OF THE ELECTRODE REMAINED IN THE ABDOMINAL CAVITY. WHILE ATTEMPTING THIS, THE ELECTRODE DISLODGED FROM THE HAND PIECE BECAUSE THE LOCKING RING FOR THE ELECTRODE DID NOT LOCK INTO PLACE. THE REPORTER INDICATED THAT THE LOCKING RING DID NOT FIT PROPERLY INTO THE HAND PIECE. THE RESULTING FORCE THAT WAS APPLIED TO THE HAND PIECE WAS TRANSFERRED TO THE ELECTRODE CAUSING THE TIP TO PUNCTURE THE PATIENT'S LIVER BED, CAUSING A LOSS OF 150 CC OF BLOOD. THE BLEEDING WAS CONTROLLED THROUGH THE USE OF MECHANICAL PRESSURE USING A SPONGE AND INSTRUMENT, FOLLOWED BY CAUTERIZATION OF THE WOUND UNTIL HEMOSTASIS WAS ACHIEVED. THIS RESULTED IN A DELAY OF 15 MINUTES TO THE PROCEDURE. THE PATIENT INJURY WAS REPORTED AS TEMPORARY, WITH NO FURTHER INFORMATION PROVIDED.

  Patient problems: Blood Loss; Bowel Perforation

  MAUDE report 7061503 ↗