UNIVERSAL PLUS 60-5274-032Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 30653405010702), received between Mar 7, 2016 and Jan 13, 2026 — classified as 1 injury, 15 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 13, 2026Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5274-032 LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING DEVICE, WAS BEING USED DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY AND ADNEXAL TUMOR RESECTION PROCEDURE ON (B)(6) 2025 WHEN IT WAS REPORTED, ¿THE TIP OF THE SPATULA WAS DAMAGED AND DETACHED.¿. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE DID FRAGMENT AND FALL INTO THE SURGICAL SITE AND WAS REMOVED WITH THE USE OF A FORCEP. THE PROCEDURE WAS COMPLETED WITH THE USE THE SAME ALTERNATE DEVICE AND THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24051876 ↗
• MalfunctionNov 11, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-032, LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING WAS BEING USED ON (B)(6)2024 DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY AND THE ¿ELECTRODE TIP WAS BROKEN AND FELL INTO THE PATIENT'S BODY. THE FRAGMENT WAS RETRIEVED FROM THE PATIENT AND THE SURGERY WAS COMPLETED USING A NEW PIECE OF THE SAME OTHER DEVICE. NO MEDICAL INTERVENTION WAS PERFORMED AND THE SURGERY TIME WAS NOT EXTENDED.¿. THERE WAS NO INJURY OR IMPACT TO THE PATIENT. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20651615 ↗
• MalfunctionSep 19, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-5274-032, LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING DEVICE WAS BEING USED DURING A UTERINE ADNEXAL TUMOR REMOVAL PROCEDURE ON (B)(6) 2024, AND ¿THE ELECTRODE WAS DETACHED FROM THE CANNULA.¿. FOLLOW-UP ASSESSMENT FOUND A FRAGMENT FELL INTO THE PATIENT AND WAS RETRIEVED WITH FORCEPS. THE SURGERY WAS COMPLETED AS NORMAL WITH AN ALTERNATE SAME DEVICE AND NO REPORTED DELAY. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR 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 20255795 ↗
• MalfunctionSep 3, 2024Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF A CUSTOMER THAT THE 60-5274-032, SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS) DEVICE WAS BEING USED DURING AN UNNAMED PROCEDURE ON 01AUG24, AND ¿THE TIP OF ELECTRODE WAS DETACHED DURING SURGERY¿. FOLLOW-UP ASSESSMENT ¿CONFIRMED THE ELECTRODE CAME OFF AFTER BEING REMOVED FROM THE PATIENT'S BODY. HOWEVER, THEY WERE UNABLE TO OBTAIN THE PROCEDURE TYPE. IN THIS CASE, EVEN THOUGH THE DEVICE DID NOT FALL OUT OF THE PATIENT'S BODY, THERE WAS A POSSIBILITY THAT IT MIGHT BE LEFT BEHIND, SO A REPORT MUST BE SUBMITTED TO THE AUTHORITIES IN JAPAN." IT WAS FURTHER CLARIFIED THAT "NO FRAGMENTS HAD FALL INTO THE PATIENT'S BODY". THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR 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 20126586 ↗
• MalfunctionMar 19, 2024Material Separation; Material Separation

  THE CUSTOMER REPORTED THAT THE 60-5274-032, SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS), WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED "THE SPATULA ELECTRODE WAS DETACHED AND FELL OFF DURING THE SURGERY." IT WAS ALSO REPORTED THAT "THE ELECTRODE FELL OUT INTO THE PATIENT'S BODY AND WAS REMOVED USING CROCE FORCEPS (INTESTINE FORCEPS)." THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR PROLONGED HOSPITALIZATION FOR 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 18929067 ↗
• MalfunctionSep 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE 60-5274-032-SPATULA ELECTROD W/STEALTH ER 5MM X 32 CM ¿THE ELECTRODE TIP WAS DETACHED, WHEN WIPING OFF THE SCORCH ON THE ELECTRODE. SINCE THE ELECTRODE DETACHMENT OCCURRED ON THE INSTRUMENT TABLE.¿ IT WAS REPORTED THAT THIS OCCURRED DURING SURGERY WITH NO IMPACT ON THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. ADDITIONALLY, THE DEVICE DID NOT MALFUNCTION IN A CATASTROPHIC MANNER; AS A RESULT, THE PROBABILITY OF THE EVENT LEADING TO SERIOUS INJURY OR DEATH IS REMOTE. THIS TYPE OF FAILURE MODE WOULD BE OBVIOUS TO THE USER PROMPTING THE USE OF AN ALTERNATE DEVICE. BASED ON THE DECISION TREE RESULTS AND PROVIDED INFORMATION, THIS COMPLAINT DOES NOT MEET THE REGULATORY DEFINITION OF A REPORTABLE EVENT. HOWEVER, CONMED JAPAN HAS REPORTED THIS EVENT AND A MEDWATCH REPORT WILL BE FILED IN CONJUNCTION WITH ALL OUS ADVERSE EVENTS. 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 17844092 ↗
• MalfunctionJul 28, 2023Material Fragmentation; Material Fragmentation

  CONMED AUSTRALIA REPORTED ON BEHALF OF THE CUSTOMER THAT THE (B)(4), SPATULA ELECTROD W/STEALTH ER WAS BEING USED ON (B)(6) 23 DURING AN UNKNOWN PROCEDURE AND THAT THE ¿SPATULA TIP END BROKE OFF INSIDE PATIENT WHILE OPERATING. IMMEDIATELY REPLACED ITEM FOR SURGEONS AFTER THEY RETRIEVED THE TIP FROM INSIDE THE PATIENT.". THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. THERE WAS A 2 MINUTE DELAY TO THE PROCEDURE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17412589 ↗
• InjuryDec 5, 2022Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-032, SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS) WAS BEING USED DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE ON (B)(6) 2022, WHEN IT WAS REPORTED, ¿THE ELECTRODE COATING WAS PEELING OFF WHILE USING AT THE SURGERY. ALTHOUGH IT HAS NOT BEEN CONFIRMED THAT IT REMAINS INSIDE THE BODY, IT CANNOT BE COMPLETELY RULED OUT THAT THERE IS A POSSIBILITY OF IT REMAINING INSIDE THE BODY¿. THE PROCEDURE WAS COMPLETED WITH ANOTHER 60-5274-032, SPATULA ELECTROD DEVICE. THE DELAY WAS ONLY FOR THE TIME IT TOOK TO PREPARE THE REPLACEMENT. AFTER FURTHER ASSESSMENT QUESTIONS IT WAS DISCOVERED THE PIECE OF THE FRAGMENTED DEVICE WAS NOT RETRIEVED. XRAY IMAGING WAS USED TO HELP LOCATE THE MISSING PIECE, BUT IT WAS UNSUCCESSFUL. THERE ARE NO REPORTS OF MEDICAL INTERVENTION OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY WITH THE POTENTIAL OF FRAGMENTATION BEING LEFT BEHIND.

  Patient problems: Foreign Body In Patient

  MAUDE report 15917038 ↗
• MalfunctionJul 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-032, SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS), WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2022 WHEN IT WAS REPORTED THAT THE ¿TIP OF ELECTRODE WAS DETACHED DURING THE SURGERY.¿ FURTHER ASSESSMENT FOUND THE PROCEDURE WAS COMPLETED AND THERE WAS NO DELAY TO THE SURGERY REPORTED. THE TIP OF THE DEVICE WAS IN THE STERILE FIELD WHEN IT BECAME DETACHED FROM THE DEVICE AND FELL INTO THE SURGICAL SITE. THE TIP WAS RETRIEVED USING GRASPING FORCEPS. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THE PATIENT¿S CURRENT STATUS IS UNKNOWN. 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 15029029 ↗
• MalfunctionJun 27, 2022Peeled/Delaminated; Peeled/Delaminated

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-032, SPATULA ELECTROD W/STEALTH ER 5MM X 32CM (5/CS) WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON AN UNKNOWN DATE WHEN IT WAS REPORTED THAT THE ¿TIP COATING OF ELECTRODE WAS PEELING DURING THE SURGERY. SEEMS THAT THE HOSPITAL IS PRESUMED TO BE AN INITIAL DEFECT, AND IT IS UNKNOWN WHETHER IT CAME OFF DURING USE WITH ELECTRICITY (THERE IS BLOOD ADHESION).¿ IT WAS REPORTED THAT THERE WAS NO DELAY TO SURGERY AND THAT AN UNKNOWN ALTERNATE DEVICE WAS USED TO COMPLETE THE PROCEDURE. FURTHER ASSESSMENT FOUND THAT THE DEVICE DID NOT FRAGMENT AND DID NOT FALL INTO THE SURGICAL SITE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR 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 14830539 ↗
• MalfunctionJun 14, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-032, SPATULA ELECTROD W/STEALTH ER WAS BEING USED ON 30MAY22 DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THAT THE TIP OF ELECTRODE WAS DETACHED DURING THE SURGERY. IT WAS DROPPED OFF INTO THE PATIENT BODY BUT IT WAS SUCCESSFULLY RETRIEVED FROM THE BODY.¿ AN ALTERNATE UNKNOWN DEVICE WAS USED TO COMPLETE THE SURGERY." THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ANY PROLONGED HOSPITALIZATION FOR THE PATIENT. AFTER FURTHER ASSESSMENT IT WAS FOUND THAT THERE WAS A DELAY OF ¿SEVERAL MINUTES¿. THE FRAGMENT WAS RETRIEVED WITH LAPAROSCOPIC FORCEPS. 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 14684845 ↗
• MalfunctionSep 26, 2018Nonstandard Device; Nonstandard Device

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-032 DEVICE SHRINK SLEEVE WAS NOT FIXED INTO PLACE. IT IS UNKNOWN IF THIS WAS AN OBVIOUS FAILURE TO THE USER. THIS WAS DISCOVERED BEFORE SURGERY AND THE DEVICE WAS NOT USED; HOWEVER, A SIMILAR FAILURE MODE HAS BEEN REPORTED WITHIN THE PAST TWO YEARS. THIS REPORT IS BEING RAISED ON THE BASIS OF DEVICE MALFUNCTION.

  Patient problems: No Patient Involvement

  MAUDE report 7910330 ↗
• MalfunctionMay 4, 2018Delivered as Unsterile Product; Delivered as Unsterile Product

  THE DISTRIBUTOR IN (B)(6) REPORTED A "DAMAGE" ON THE STERILE POUCH OF THIS (B)(4), 5MM,SPATULA W/STEALTH,32 CM . THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A DEVICE MALFUNCTION DUE TO A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7486301 ↗
• MalfunctionFeb 14, 2018Packaging Problem; Packaging Problem

  THE DISTRIBUTOR IN (B)(4) REPORTED A "TEAR" ON THE STERILE POUCH OF THE DEVICE. THERE WAS NO PATIENT INVOLVEMENT AS THIS DEFECT WAS DISCOVERED DURING INCOMING INSPECTION. THIS REPORT IS RAISED ON THE BASIS OF A STERILITY BREACH FOUND DURING THE DEVICE EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 7270658 ↗
• MalfunctionJan 4, 2017Material Separation; Material Separation

  AS REPORTED BY THE DISTRIBUTOR, DURING A LAPAROSCOPIC PROCEDURE ON (B)(6) -2016, "THE SHRINK TUBE WAS DROPPED OFF FROM THE ELECTRODE DURING SURGERY." THE SURGERY WAS COMPLETED USING AN ALTERNATE DEVICE, 60-6010-003 WITH NO PATIENT INJURY OR REPORTED DELAY. THIS REPORT IS BEING FILED WITH THE POTENTIAL FOR INJURY WITH RECURRENCE. NO FURTHER INFORMATION HAS BEEN RECEIVED, NOR HAS A DEVICE BEEN RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6221985 ↗
• MalfunctionMar 7, 2016Detachment Of Device Component; Component Falling; Material Separation

  THE CUSTOMER REPORTED THAT WHILE UTILIZING A UNIVERSAL PLUS LAPAROSCOPIC SPATULA ELECTRODE WITH ULTRA NON-STICK COATING, SUCTION/IRRIGATION LUMEN, IN A LAPAROSCOPIC VENTRAL HERNIA REPAIR, THE BLACK PLASTIC INSULATION ON THE ELECTRODE FELL OFF OF THE SPATULA INTO THE PATIENT'S PERITONEAL CAVITY. THE INSULATION COATING WAS REMOVED FROM THE PERITONEAL CAVITY WITH NO PROBLEMS REPORTED. THE REPORT FURTHER STATED A SECOND SPATULA WITH A DIFFERENT LOT NUMBER WAS OPENED AND INTRODUCED INTO THE STERILE FIELD FOR SURGICAL USE. THE INSULATION BEGAN SEPARATING FROM THE SHAFT ALSO, BUT THAT THE BLACK PLASTIC INSULATION DID NOT FALL FREE FROM THE DEVICE. AT THIS POINT, THE SURGEON CHANGED THE SURGICAL PROCEDURE FROM A LAPAROSCOPIC CASE TO AN OPEN VENTRAL HERNIA REPAIR DUE TO THE MEDICAL REASON OF COMPLICATED ADHESIONS WITHIN THE PATIENT'S PERITONEAL CAVITY. THE SURGICAL PROCEDURE WAS OTHERWISE COMPLETED WITHOUT FURTHER INCIDENT OR PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5484932 ↗

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