UNIVERSAL PLUS 60-5274-132Recalls & reported problems

Summary

The FDA's MAUDE database contains 29 adverse event reports that list this exact device (DI 30653405010733), received between Sep 1, 2016 and Dec 3, 2024 — classified as 6 injuries, 23 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (8 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 25 most recent of 29 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING WAS BEING USED ON (B)(6) 2024 AND ¿THE ELECTRODE PART CAME OFF WHILE IT WAS BEING TAKEN OUT OF THE PATIENT'S BODY.¿. PER FURTHER ASSESSMENT IT WAS FOUND THAT "THE SURGEON WAS WIPING AWAY THE SCORCH ON THE ELECTRODE WITH GAUZE WHEN IT CAME OFF.". THERE WAS NO IMPACT OR INJURY TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. 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 20834696 ↗
• MalfunctionOct 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, LAPAROSCOPIC ELECTRODE WITH ESCHAR-RESISTANT COATING WAS BEING USED ON (B)(6) 2024 DURING A LAPAROSCOPIC CHOLECYSTECTOMY AND ¿DURING USE, THE ELECTRODE TIP CAME OFF. THE PART THAT FELL INTO THE BODY WAS RETRIEVED. IN THE FIRST DEVICE, THE ELECTRODE CAME OFF WHILE BEING WIPED OUTSIDE THE BODY. THEREFORE, THE FACILITY REPLACED IT TO THE SAME NEW DEVICE. HOWEVER, THE REPLACED ELECTRODE CAME OFF INSIDE THE PATIENT'S BODY WHILE IT WAS BEING REPLACED AND USED. THE DETACHED ELECTRODE WAS RETRIEVED WITH FORCEPS.¿. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE SAME DEVICE. 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 20523536 ↗
• MalfunctionAug 6, 2024Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE ON (B)(6) 2024 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT L-HOOK ELECTRODE WAS DETACHED DURING THE SURGERY.¿. FURTHER ASSESSMENT FOUND THAT THE COMPONENT DETACHMENT OCCURRED OUTSIDE OF THE PATIENT; THEREFORE, NO FRAGMENTATION MADE CONTACT TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER SAME DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR 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 19916946 ↗
• MalfunctionJun 17, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON 29MAY24 AND ¿IT WAS REPORTED THAT THE L-HOOK ELECTRODE WAS DETACHED DURING THE SURGERY.¿. PER FURTHER ASSESSMENT IT WAS FOUND "IT WAS INITIALLY REPORTED THAT THE ELECTRODE FELL OUT WITHIN THE ABDOMINAL CAVITY, BUT IT WAS CONFIRMED THAT THE ELECTRODE FELL OUT OUTSIDE THE ABDOMINAL CAVITY.". THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION 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 19548246 ↗
• MalfunctionJun 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON (B)(6) 24 DURING A UTERINE SALPINGO-OOPHORECTOMY AND ¿IT WAS REPORTED THAT AT THE BEGINNING OF THE SURGERY, WHILE USING THE CANNULA L-HOOK ELECTRODE WITH AN ELECTRODE, IT CAME OFF AND FELL INTO THE ABDOMINAL CAVITY, BUT THE ELECTRODE WAS QUICKLY REMOVED USING GRASPING FORCEPS.¿ THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. AN UNKNOWN ALTERNATE DEVICE WAS USED. 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 19484335 ↗
• MalfunctionNov 3, 2023Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON (B)(6) 2023 DURING A LAPAROSCOPIC TOTAL HYSTERECTOMY PROCEDURE AND ¿IT WAS REPORTED THAT THE TIP OF ELECTRODE DETACHED AND DROPPED OFF DURING EXTRAPERITONEAL OPERATION. THERE WAS NO SHEDDING INTO THE PATIENT'S BODY. ON (B)(6) UPDATED: ¿IT WAS CONFIRMED THAT THE TIP OF THE SHAFT WAS DAMAGED AND THERE WERE BROKEN PIECES, RATHER THAN THE ELECTRODE TIP COMING OFF.¿. THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION 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 18064635 ↗
• MalfunctionNov 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT THE INSULATION COVER DETACHED FROM THE CANNULA¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THERE WAS NO REPORT OF FRAGMENTATION OF THE DEVICE AND NO COMPONENT FELL INTO THE SURGICAL SITE. THE PROCEDURE WAS COMPLETED USING A ALTERNATE, SAME DEVICE AND THERE WAS NO REPORT OF PROCEDURE DELAY. 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 18064062 ↗
• MalfunctionOct 26, 2023Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING A LAPAROSCOPIC PARTIAL LIVER RESECTION PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿IT WAS REPORTED THAT THE L-HOOK ELECTRODE WAS DETACHED AND FELL INTO THE SURGICAL FIELD DURING THE SURGERY. THE ELECTRODE WAS RETRIEVED AND THERE WAS NO RESIDUE INSIDE THE BODY.¿. THE FRAGMENTATION WAS REMOVED FROM THE PATIENT USING GRASPING FORCEPS. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THE PROCEDURE WAS REPORTED AS BEING COMPLETED WITH ONLY A FEW SECONDS OF DELAY. 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 18010154 ↗
• MalfunctionSep 21, 2023Peeled/Delaminated; Peeled/Delaminated

  CONMED JAPAN REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5274-132-STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON (B)(6) 2023 AND THE ¿INSULATION PART OF THE ELECTRODE SEEMED TO HAVE FUZZ LOOKS LIKE PEELING.¿ THERE WAS NO REPORT OF IMPACT/INJURY, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION TO THE PATIENT. THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE DEVICE. 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 17792136 ↗
• MalfunctionJul 14, 2023Material Fragmentation; Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING A LAP CHOLE PROCEDURE ON (B)(6) 2023 WHEN IT WAS REPORTED, ¿THE LAPAROSCOPIC L HOOK BROKE OFF DURING THE PROCEDURE.¿. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE USER OR PATIENT. THE PROCEDURE WAS COMPLETED AS PLANNED WITH A FEW MINUTES DELAY. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE COMPONENT FELL INTO THE ABDOMINAL CAVITY OF THE PATIENT AND WAS RETRIEVED USING LAP GRASPERS. THE PATIENT WAS DISCHARGED AS NORMAL. 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 17324541 ↗
• InjuryAug 5, 2022Material Split, Cut or Torn; Excessive Heating; Material Split, Cut or Torn; Excessive Heating

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT DURING AN UNKNOWN SURGERY ON (B)(6) 2022 IT WAS REPORTED THAT THE ¿60-5274-132 STEALTH 32 LHOOK LAP ELEC WAS NOT ENERGIZED FROM THE ELECTRODE PART, BUT IS ENERGIZED FROM THE OUTER CYLINDER, WHICH IS AN INTERMEDIATE ROUTE.¿ IT WAS CONFIRMED BY THE FACILITY THAT THERE WAS A CRACK ON THE CANNULA. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE SAME DEVICE. FURTHER ASSESSMENT FOUND THE POSITION WHERE ENERGIZATION OCCURRED IS UNKNOWN. "HOWEVER, DURING THE OPERATION, THE TIP OF THE SHAFT WILL ONLY ENTER THE BODY ABOUT 2 TO 3 CENTIMETERS. IN ADDITION, PART OF THE LIVER TURNED WHITE DURING THE OPERATION, SO THERE IS DOUBT THAT THE LIVER WAS MISTAKENLY BURNT". IT WAS JUDGED BY THE FACILITY THAT IS WHERE THE DEVICE ENERGIZED. "NO SPECIAL TREATMENT WAS GIVEN TO THE DAMAGED LIVER.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO A BURN TO THE LIVER.

  Patient problems: Burn(s)

  MAUDE report 15175787 ↗
• InjuryJul 12, 2022Peeled/Delaminated; Peeled/Delaminated

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON (B)(6) 2022 DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THAT THE TIP COATING OR INSULATION TUBE OF L-HOOK ELECTRODE WAS PEELED OFF DURING THE SURGERY. THEREFORE, THE USE OF THAT DEVICE WAS DISCONTINUED.¿ 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. AN ALTERNATE DEVICE OF THE SAME WAS USED TO COMPLETE THE PROCEDURE AND THIS DEVICE ALSO PEELED. FURTHER ASSESSMENT FOUND THAT THE PROCEDURE WAS DELAYED APPROXIMATELY 1 TO 1.5 HOURS AND IT IS UNKNOWN IF A FRAGMENT FELL INTO THE SURGICAL SITE. ¿CLEANING WAS PERFORMED MORE THAN USUAL.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO FRAGMENTS OF THE DEVICE POTENTIALLY REMAINING IN THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14988248 ↗
• InjuryJun 17, 2022Material Fragmentation; Peeled/Delaminated; Material Fragmentation; Peeled/Delaminated

  CONMED (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON (B)(6) 2022 DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THAT THE TIP COATING OR INSULATION TUBE OF L-HOOK ELECTRODE WAS PEELED OFF DURING THE SURGERY. THEREFORE, THE USE OF THAT DEVICE WAS DISCONTINUED.¿ 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. AN ALTERNATE DEVICE OF THE SAME WAS USED TO COMPLETE THE PROCEDURE. FURTHER ASSESSMENT FOUND THAT THE PROCEDURE WAS DELAYED APPROXIMATELY 1 TO 1.5 HOURS AND IT IS UNKNOWN IF A FRAGMENT FELL INTO THE SURGICAL SITE. ¿CLEANING WAS PERFORMED MORE THAN USUAL.¿ THIS REPORT IS BEING RAISED ON THE BASIS OF POTENTIAL INJURY BASED UPON THE LACK OF INFORMATION REGARDING IF FRAGMENTS FELL INTO THE PATIENT AND POTENTIALLY REMAIN.

  Patient problems: Insufficient Information

  MAUDE report 14735081 ↗
• MalfunctionJun 6, 2022Material Fragmentation; Material Fragmentation

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING TESTED PRE-OPERATIVELY ON 11MAY2022 FOR A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE WHEN IT WAS REPORTED ¿THAT THE L-HOOK ELECTRODE CAME OFF AFTER THE ELECTRODE WAS MOVED IN AND OUT OF THE CANNULA SEVERAL TIMES DURING THE PRE-OPERATIVE CHECK.¿ THE PROCEDURE WAS COMPLETED WITH AN ALTERNATE UNKNOWN DEVICE. THERE WAS NO IMPACT OR INJURY TO THE PATIENT OR USER. ON MAY 19TH ADDITIONAL INFORMATION WAS RECEIVED FROM THE DISTRIBUTOR. ¿IT WAS REPORTED THAT THE HOOK HAD COME OFF FROM THE FACILITY, BUT WHEN THE AGENCY OBSERVED THE ACTUAL PRODUCT, IT WAS SAID THAT THE COATING ON THE HOOK WAS MISSING.¿ ON MAY 24TH IT WAS REPORTED THAT ¿THE DEVICE WAS OBSERVED AND FOUND THE COATING WAS PEELED AND DETACHED, ALSO THE POSITION OF THE INSULATION TUBE WAS MISALIGNED AND DAMAGED.¿ 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 14601148 ↗
• MalfunctionJun 1, 2022Melted; Melted

  CONMED JAPAN REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON 25APRIL2022 WHEN IT WAS REPORTED THAT, ¿IT WAS REPORTED THAT THE INSULATION TUBE OF ELECTRODE HAD MELTED ABOUT 30 MIN TO 1HOUR AFTER THE START OF USE.¿ THE PROCEDURE WAS COMPLETED USING AN ALTERNATE UNKNOWN DEVICE AND THERE WAS NO REPORT OF A TIME DELAY FOR THE SURGERY. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE WAS IN THE STERILE FIELD WHEN IT BROKE HOWEVER THE DEVICE DID NOT FRAGMENT AND THE DEVICE DID NOT FALL INTO THE SURGICAL SITE. FURTHER CLARIFICATION WAS NEEDED REGARDING IF INSULATION COATING MELTED OR PEELED, AND IT WAS DETERMINED THAT THE INSULATION COATING WAS NOT PEELING. IT WAS REPORTED THAT THERE WAS NO INJURY TO PATIENT AND NO MEDICAL/SURGICAL INTERVENTION OR 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 14566390 ↗
• MalfunctionJun 1, 2022Melted; Melted

  CONMED (B)(6) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT, ¿THAT THE COATING MELTED ABOUT 30 MIN TO 1 HOUR AFTER THE START OF USE. 6 OUT OF 8 ARE UNOPENED.¿ BOTH OPENED BOTTLES SHOWED EVIDENCE THAT THE COATING HAD MELTED. THE PROCEDURE WAS COMPLETED USING AN ALTERNATE UNKNOWN DEVICE AND THERE WAS NO REPORT OF A TIME DELAY FOR THE SURGERY. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE DEVICE WAS IN THE STERILE FIELD WHEN IT BROKE HOWEVER THE DEVICE DID NOT FRAGMENT AND THE DEVICE DID NOT FALL INTO THE SURGICAL SITE. IT WAS REPORTED THAT THERE WAS NO INJURY TO PATIENT AND NO MEDICAL/SURGICAL INTERVENTION OR 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 14565515 ↗
• MalfunctionApr 29, 2022Peeled/Delaminated; Peeled/Delaminated

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING A LAPAROSCOPIC UTERINE MYOMECTOMY PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED THAT, ¿ABOUT 1 HOUR AFTER THE START OF OPERATION, THE INSULATING COATING ON THE ELECTRODES BROKE AND BECAME HANGNAIL-LIKE AND ADHERED TO THE TIP.¿ THE PROCEDURE WAS COMPLETED USING AN ALTERNATE UNKNOWN DEVICE AND THERE WAS NO TIME DELAY FOR THE SURGERY. FURTHER ASSESSMENT QUESTIONING FOUND THAT THE OBSTETRICIAN-GYNECOLOGIST WAS THE INITIAL REPORTER, THE DEVICE WAS IN THE STERILE FIELD WHEN IT BROKE HOWEVER THE DEVICE DID NOT FRAGMENT AND THE DEVICE 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 14250020 ↗
• MalfunctionMar 19, 2022Peeled/Delaminated; Peeled/Delaminated

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY ON (B)(6) 2022 WHEN IT WAS REPORTED ¿THAT THE CUSTOMER FOUND PEELING OF THE L-HOOK ELECTRODE COATING DURING SURGERY. DURING THE OPERATION, THEY FOUND PEELING OF THE L HOOK COATING BEFORE USING IT FOR THE PATIENT, SO THEY PREPARED AN ALTERNATIVE DEVICE, BUT IT WAS ALSO CONFIRMED TO PEEL OFF. THEREFORE, SURGERY WAS PERFORMED WITH THE THIRD DEVICE AND COMPLETED WITHOUT ANY PROBLEM.¿. A SECOND DEVICE, SAME LOT, EXPERIENCED THE SAME TYPE OF MALFUNCTION; HOWEVER, A THIRD, SAME-LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO REPORT OF FRAGMENTATION CONTACT TO THE PATIENT. 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 13823719 ↗
• MalfunctionMar 3, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  CONMED (B)(4) REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS OPENED IN PRE-OPERATIVE TESTING ON (B)(6) 2022 FOR AN UNKNOWN PROCEDURE WHEN IT WAS REPORTED ¿THAT THE TIP OF ELECTRODE WAS BROKEN, SO THE CUSTOMER REPLACED IT WITH THE NEW DEVICE. CONFIRMED THAT WHEN THE CUSTOMER OPENED THE PACKAGE, THEY FOUND THAT THE TIP OF ELECTRODE WAS DETACHED FROM THE CANNULA.¿ THE DEVICE WAS NOT USED ON A PATIENT. THIS INCIDENT DID NOT OCCUR WHILE IN THE STERILE FIELD. 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 13661072 ↗
• MalfunctionMar 2, 2022Material Fragmentation; Material Fragmentation

  THE CUSTOMER REPORTED THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG, WAS BEING USED DURING AN UNKNOWN TYPE OF PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED ¿L-HOOK WAS FELL INTO THE PATIENT'S BODY WHEN THE L HOOK WAS USED INTRAPERITONEALLY DURING THE SURGERY. THE SURGEON FOUND AND RETRIEVED IT FROM THE PATIENT'S BODY¿. THE PROCEDURE WAS REPORTED AS HAVING BEEN COMPLETED AS PLANNED. 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 13651069 ↗
• InjuryFeb 23, 2022Arcing; Arcing

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON APPROXIMATELY (B)(6) 2022 DURING A LAP CHOLE AND THE DEVICE WAS REPORTED AS ¿SPARKING AND BURNING THROUGH THE L-HOOK BLACK SHAFT. IT ENDS UP BURNING THE LIVER. ¿. FURTHER ASSESSMENT FOUND, THEY WERE USING THE L HOOK TO ¿DISSECT THE GALLBLADDER FROM THE LIVER. WHILE WE WERE WORKING, WE NOTICED AN ARC FROM THE L HOOK SHEATH TO THE LIVER WHICH CAUSED A BURN.¿ THE BURN WAS 2ND DEGREE. THE PATIENT WAS REPORTED AS RECOVERING WELL AND THERE WAS NO EXTENDED STAY AT THE HOSPITAL. THE PROCEDURE WAS COMPLETED, ¿EXCEPT FOR THE BURNS TO THE LIVER FROM DEVICE.¿. THE ELECTRO SURGICAL UNIT USED WAS THE OLYMPUS AND THE SETTINGS WERE 35. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO ALLEGATION AGAINST THE 60-6010-005, UNIVERSAL PLUS STRAIGHT-ROCKER AND IT WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO 2ND DEGREE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13584000 ↗
• InjuryFeb 23, 2022Arcing; Arcing

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, 60-5274-132, STEALTH 32 LHOOK LAP ELEC PKG WAS BEING USED ON APPROXIMATELY (B)(6) 2022 DURING A LAP CHOLE AND THE DEVICE WAS REPORTED AS ¿SPARKING AND BURNING THROUGH THE L-HOOK BLACK SHAFT. IT ENDS UP BURNING THE LIVER.¿ FURTHER ASSESSMENT FOUND, THEY WERE USING THE L HOOK TO ¿DISSECT THE GALLBLADDER FROM THE LIVER. WHILE WE WERE WORKING, WE NOTICED AN ARC FROM THE L HOOK SHEATH TO THE LIVER WHICH CAUSED A BURN. THIS ACTION HAPPENED 3 TIMES IN THE FIRST CASE AND AGAIN IN THE SECOND CASE.¿ THE BURN WAS 2ND DEGREE. THE PATIENT WAS REPORTED AS RECOVERING WELL AND THERE WAS NO EXTENDED STAY AT THE HOSPITAL. THE PROCEDURE WAS COMPLETED, ¿EXCEPT FOR THE BURNS TO THE LIVER FROM DEVICE.¿. THE ELECTRO SURGICAL UNIT USED WAS THE OLYMPUS AND THE SETTINGS WERE 35. THERE WAS NO DELAY TO THE PROCEDURE. THERE WAS NO ALLEGATION AGAINST THE 60-6010-005, UNIVERSAL PLUS STRAIGHT-ROCKER AND IT WILL BE LISTED AS A CONCOMITANT DEVICE. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO 2ND DEGREE BURN.

  Patient problems: Partial thickness (Second Degree) Burn

  MAUDE report 13583999 ↗
• InjurySep 1, 2021Fracture; Fracture

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE 60-5274-132 WAS BEING USED DURING A LAPAROSCOPIC APPENDECTOMY ON (B)(6) 2021 WHEN IT WAS REPORTED ¿ON 5/23/21, A PATIENT WAS TAKEN TO THE OR FOR A LAPAROSCOPIC APPENDECTOMY. DURING THE SURGERY, THE SURGEON ASKED FOR A SECOND L HOOK CAUTERY (THE CONMED DEVICE) BECAUSE THE FIRST ONE OPENED HAD A ¿BENT TIP¿. THE SECOND DEVICE WAS OPENED, AND THE SURGERY PROCEEDED. AFTER SURGERY, THE PATIENT REMAINED IN THE HOSPITAL DUE TO FEVER. ON (B)(6) 2021, A CT SCAN WAS DONE, AND A METALLIC OBJECT WAS SEEN ON THE CT. THE STAFF WHO WERE IN THE FIRST CASE WERE ALSO THERE ON (B)(6) AND LOOKED FOR THE DISCARDED CONMED DEVICE THAT WAS TAKEN OUT OF SERVICE DURING THE FIRST SURGERY. THEY FOUND IT AND NOTED THAT THE TIP WAS BROKEN OFF. DURING THE SECOND SURGERY ON (B)(6) 2021, THE SURGEON RETRIEVED THE TIP OF THE DEVICE.¿ THE DETAILS OF THE PROLONGED HOSPITALIZATION ARE UNKNOWN; HOWEVER, THE PATIENT DID UNDERGO A SECONDARY SURGERY ON (B)(6) 2021 TO REMOVE THE DEVICE COMPONENT. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY DUE TO THE SECONDARY SURGERY TO REMOVE THE DEVICE COMPONENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12410005 ↗
• MalfunctionAug 6, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT 60-5274-132 LINING SHEATH CAME OFF ITS SEAT ON (B)(6) 2019 DURING A LAPAROSCOPIC CHOLECYSTECTOMY. IT IS THOUGHT THAT THIS DESCRIPTION IS DEFINING THE LOSS OF THE SHEATH. FURTHER ASSESSMENT INFORMATION WAS REQUESTED; HOWEVER, ADVISEMENT WAS THAT THERE IS NO FURTHER INFORMATION AVAILABLE. THERE WAS NO REPORT OF INJURY TO THE PATIENT. THE CUSTOMER COMPLAINT FORM DOES NOT STATE THAT THE COMPONENT CAME INTO CONTACT WITH THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8863787 ↗
• MalfunctionOct 9, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  THIS DISTRIBUTOR REPORTED ON BEHALF OF THEIR CUSTOMER THAT THE 60-5274-132 DEVICE SHRINK SLEEVE WAS NOT FIXED INTO PLACE. THIS WAS DISCOVERED DURING SURGERY AND THE DEVICE WAS NOT USED; HOWEVER, A SIMILAR FAILURE MODE HAS BEEN REPORTED WITHIN THE PAST TWO YEARS. DUE TO THE EXPLANATION OF THE FAILURE MODE IN THAT REPORTING, THIS EVENT HAS THE POTENTIAL FOR INJURY DUE TO THIS MALFUNCTION. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7948637 ↗

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