UNIVERSAL PLUS 60-5274-144Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 30653405010740), received between Dec 30, 2021 and Nov 19, 2024 — classified as 1 injury, 1 malfunction.

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

1 other recall cover devices cleared under the same FDA submission (K952204); they may or may not involve this specific model.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryNov 19, 2024Arcing; Arcing

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-5274-144, LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING, WAS BEING USED DURING A LAP ANTERIOR RESECTION PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿I WAS HANDED A YELLOW BAG AND LABEL CONTAINING THE UNIVERSAL PLUS L HOOK ALONG WITH THE NURISING NOTE STATING "HOOK KEPT ARCHING OUT CAUSING MULTIPLE BOWEL INJURY.". THERE WAS NO REPORT OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. FURTHER ASSESSMENT HAS BEEN REQUESTED; HOWEVER, TO DATE WE HAVE NOT RECEIVED ANY ADDITIONAL INFORMATION. THIS REPORT IS BEING RAISED DUE TO THE POTENTIAL REPORTED INJURY OF BOWEL DURING SURGERY.

  Patient problems: Bowel Burn; Burn(s)

  MAUDE report 20723347 ↗
• MalfunctionDec 30, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-5274-144, STEALTH 44 LHOOK LAP ELEC PKG WAS BEING USED ON (B)(6) 2021 DURING A BARIATRIC PROCEDURE AND ¿ELECTRODE FELL INTO THE PATIENT¿S ABDOMINAL CAVITY UPON INSERTION. IT WAS FISHED OUT AND RETRIEVED BY THE SURGEON.¿ THERE WAS A DELAY OF 2 MINUTES. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13117220 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K952204. One submission often covers many models, so check the product and lot details in each record.

• Z-1250-2022 · May 3, 2022 · Terminated
  Regard Item Number: 800214007 Sterile GS00367 - GASTRO BYPASS - SPARTANBURG. CONMED Catalog No. 60-5274-944-Needle w/ Stealth ER, 44cm, 5mm