Megadyne RS271A30Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 19005531507774), received between Jul 26, 2017 and May 19, 2026 — classified as 22 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (23 reports).

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 26 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Insufficient Device Problem Information

  ON APRIL 21ST, 2026, WE HAVE BEEN INFORMED OF AN ADVERSE EVENT INVOLVING TWO DISPERSIVE ELECTRODES. AN UNKNOWN PROCEDURE WAS PERFORMED UW HEALTH IN MADISON (USA). MEGADYNE DISPERSIVE ELECTRODE CATALOGUE NUMBER: 0855C (OUR MODEL: RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT: "IT WAS REPORTED BY DISTRIBUTOR PER ACCOUNT THAT THERE ARE TWO PATIENT INJURIES OCCURRING ON CONSECUTIVE DAYS. PADS ARE BURNING PATIENTS. UNINTENDED THERMAL INJURY LESS THAN 2ND DEGREE." IT WAS ALSO STATED IN THE INITIAL REPORT THAT THE INVOLVED "DEVICES ARE AVAILABLE FOR RETURN." NO INFORMATION ABOUT THE GENERATOR MODEL, THE POWER SETTINGS, THE PATIENTS, HOW THE SKIN WAS PREPARED, HOW THE INJURIES WERE TREATED AFTERWARDS AND A FILLED IN QUESTIONNAIRE HAVE BEEN DISCLOSED TO US SO FAR.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 25212713 ↗
• InjuryMar 30, 2026Insufficient Device Problem Information

  ON MARCH 05TH, 2026 WE HAVE BEEN INFORMED OF AN ADVERSE EVENT INVOLVING A DISPERSIVE ELECTRODE. A SHOULDER PROCEDURE WAS PERFORMED AT (b)(6) IN (b)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED.THE INITIAL REPORT WAS STATING THAT: "IT WAS REPORTED BY THE SALES REP THAT DURING A REVERSE TOTAL SHOULDER PROCEDURE, WHEN THEY PULL OFF THE DEVICE FROM THE PATIENT, THE PATIENT SKIN TORE WITH THE PAD. THE PATIENT IS OKAY AND HAD THEM "[SIC]" TREATED. "IT WAS ALSO STATED, "PRODUCT RETURN STATUS: AVAILABLE".NO INFORMATION ABOUT THE GENERATOR MODEL, THE POWER SETTINGS, THE PATIENT, HOW THE SKIN WAS PREPARED, HOW THE INJURY WAS TREATED AFTERWARDS AND A FILLED IN QUESTIONAIRE HAVE BEEN DISCLOSED TO US.

  Patient problems: Skin Tears

  MAUDE report 24726406 ↗
• MalfunctionNov 27, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON NOVEMBER 04TH, 2025, WE HAVE BEEN INFORMED OF A PRODUCT PROBLEM INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER: 0855C (OUR MODEL: RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT: "IT WAS REPORTED BY HEALTHCARE PROFESSIONAL THAT THE MEGADYNE NEUTRAL ELECTRODES ALLOW FOR THE CAUTERY GENERATOR TO SHOW "READY" WHEN THE ELECTRODES ARE NOT ATTACHED TO THE PATIENT. THIS CAN ALLOW THE PAD TO NOT BE ATTACHED TO THE PATIENT FULLY AND THEREFORE NOT GROUNDING THE PATIENT DURING A PROCEDURE AND COULD CAUSE HARM. THERE IS NO PATIENT INJURY REPORTED. DEVICE IS AVAILABLE FOR RETURN." FURTHER ON WE HAVE BEEN INFORMED THAT "NO PATIENT CONSEQUENCE, NO SIGNS, SYMPTOMS OR PATIENT INVOLVEMENT." NO FURTHER INFORMATION WAS PROVIDED ON THE GENERATOR MODEL, THE GENERATOR SETTINGS AND OTHER FURTHER DETAILS THAT MAY HAVE AN INFLUENCE ON THE INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23664166 ↗
• InjurySep 10, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2025, WE HAVE BEEN INFORMED OF AN INCIDENT INVOLVING DISPERSIVE ELECTRODES. AN UNKNOWN PROCEDURE WAS PERFORMED AT (B)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER: 0855C (OUR MODEL: RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT ": IT WAS REPORTED TO THE SALES REP BY THE SURGEON THAT WHEN PAD WAS REMOVED, THE STICKINESS CAUSED MILD SKIN IRRITATION. ONE DEVICE RETURNING. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED." NO FURTHER INFORMATION WAS PROVIDED ON THE BODY TYPE/WEIGHT OF THE PATIENT, PATIENT SKIN, WHETHER THE PLACEMENT SITE WAS PREPPED AND THE DURATION OF THE PROCEDURE.

  Patient problems: Skin Inflammation/ Irritation

  MAUDE report 23013052 ↗
• InjuryAug 12, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024 WE HAVE BEEN INFORMED OF AN INCIDENT INVOLVING DISPERSIVE ELECTRODES. A HEART ABLATION PROCEDURE WAS PERFORMED AT COX HEALTH SYSTEMS (B)(6) HOSPITAL, (B)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT ": IT WAS REPORTED THAT HEART ABLATION IN THE CATH LAB. USING 0855C AS GROUNDING PAD. POST OP A PAD SITE BURN WAS REPORTED. SURGICAL DELAY WAS UNKNOWN. DEVICE IS NOT RETURNING. I CERTIFY THAT ALL INFORMATION THAT ARE KNOWN/AVAILABLE HAS BEEN DISCLOSED." THE EVENT DATE WAS SPECIFIED AS "UNK/UNK/2025" AND THE PROCEDURE DATE AS " (B)(6) 2025" NO FURTHER INFORMATION WAS PROVIDED ON THE BODY TYPE/WEIGHT OF THE PATIENT, PATIENT SKIN, WHETHER THE PLACEMENT SITE WAS PREPPED, THE ORIENTATION OF THE DISPERSIVE ELECTRODE RELATIVE TO THE SURGICAL AREA, THE DURATION OF THE PROCEDURE.

  Patient problems: Burn(s)

  MAUDE report 22780365 ↗
• InjuryFeb 11, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024 WE HAVE BEEN INFORMED ABOUT TWO INCIDENTS INVOLVING DISPERSIVE ELECTRODES. A "CARDIOVASCULAR PROCEDURE" WAS PERFORMED (B)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT ": THE ACCOUNT CONTACT THAT POST OP TWO OPEN HEART PROCEDURES, WHEN THEY GET THE PATIENTS OUT INTO ICU TO REMOVE, THEY ARE HAVING SKIN TEARS, NO MATTER HOW CAREFUL THEY ARE WITH REMOVING THE PRODUCT. SKIN TEARS, PATIENTS HAVING TO BE TREATED FOR WOUND. CALLER DID NOT KNOW TREATMENT AT TIME OF CALL." THE EVENT DATE WAS SPECIFIED AS "UNK/UNK/2025" AND THE PROCEDURE DATE AS "(B)(6) 2025" NO FURTHER INFORMATION WAS PROVIDED ON THE BODY TYPE/WEIGHT OF THE PATIENTS, PATIENT SKIN, IF SKIN WEAKENING MEDICAL SUBSTANCES HAVE BEEN USED (E.G. STEROIDS), WHETHER THE PLACEMENT SITES WERE PREPPED, THE ORIENTATION OF THE DISPERSIVE ELECTRODEA RELATIVE TO THE SURGICAL AREA, THE DURATION OF THE PROCEDUREA DESPITE REPEATED REQUESTS.

  Patient problems: Insufficient Information

  MAUDE report 21352870 ↗
• InjuryMar 13, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2024 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A "TOTAL HIP REPLACEMENT" PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL LLC, (B)(6) TEXAS. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT ": IT WAS REPORTED BY THE SALES REP THAT DURING A TOTAL HIP REPLACEMENT, THE PATIENT HAD AN ICD AND THEY USED A MEGADYNE STICKY PAD AND THEY PUT THE PAD ON THE LEFT SHOULDER AND THE ICD WAS NOT TURNED OFF. THE LEADS WERE LATER FOUND TO BE BURNED. THEY DO NOT KNOW IF THE BURNS WERE FROM THIS SURGERY OR NOT. CASE WAS SUCCESSFULLY COMPLETED. NO DEVICE WILL BE RETURNED." THE EVENT DATE WAS SPECIFIED AS "01/UNK/2024". NO FURTHER INFORMATION WAS PROVIDED ON THE BODY TYPE/WEIGHT OF THE PATIENT, WHETHER THE PLACEMENT SITE WAS PREPPED, THE ORIENTATION OF THE DISPERSIVE ELECTRODE RELATIVE TO THE SURGICAL AREA, THE DURATION OF THE PROCEDURE AND THE ACTIVATION CYCLE DESPITE REPEATED REQUESTS.

  Patient problems: Insufficient Information

  MAUDE report 18892494 ↗
• InjuryJan 31, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6), 2024 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A "ROBOTIC ASST TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BSO" PROCEDURE WAS PERFORMED AT (B)(6)HOSPITAL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN ERBE GENERATOR (MODEL UNKNOWN) HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "SALES REP REPORTED FROM THE CUSTOMER THAT ON (B)(6) 2023, DR (B)(6) WAS PERFORMING A ROBOTIC ASST TOTAL LAPAROSCOPIC HYSTERECTOMY WITH BSO. WHEN THE PROCEDURE WAS OVER AND THE PATIENT WAS UNDRAPED, THE STAFF NOTICED A BURN WHERE THE DISPOSABLE RETURN ELECTRODE (0855C) HAD BEEN PLACED ON THE PATIENT'S RIGHT UPPER THIGH. THE BURN WAS DESCRIBED AS A FULL THICKNESS BURN APPROXIMATELY 2.5CM X 2.0CM. THE PATIENT WAS INSTRUCTED TO APPLY BACITRACIN OINTMENT DAILY. THE CAUTERY PENCIL AND DISPOSABLE RETURN ELECTRODE WERE PLUGGED INTO THE ERBE ESU (ON THE ROBOTIC TOWER) WITH SETTINGS OF 3 & 3 ON CUT & COAG RESPECTIVELY. THE PATIENT'S HOSPITAL STAY WAS NOT PROLONGED DUE TO THE BURN. DEVICE IS NOT AVAILABLE FOR RETURN." NO FURTHER INFORMATION WAS PROVIDED ON THE BODY TYPE/WEIGHT OF THE PATIENT, WHETHER THE PLACEMENT SITE WAS PREPPED, TH

  Patient problems: Burn(s)

  MAUDE report 18612607 ↗
• InjuryNov 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6), 2023 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A TILF PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKOWN GENERATOR HAD BEEN USED. THE INITIAL REPORT WAS STATING THAT "SALES REP REPORTED ELECTRODE ALARM ERROR OCCURRED MULTIPLE TIMES ON EFU DURING A TILF PROCEDURE. OR STAFF CHECKED DEVICE TO CONFIRM PLACEMENT OF 0855C. AT THE END WHEN SURGICAL DRAPES WERE REMOVED, SMALL BURN WAS DISCOVERED 2-3 MILLIMETERS RIGHT ABOVE PATIENTS CREVICE OF PATIENTS BUTTOCKS. THE STAFF COVERED THE SMALL BURN WITH STERI STRIP. AFTER NOTICING BURN, STAFF CHECKED DRAPES FOR BURN/HOLE AND NONE WERE DISCOVERED." NO FURTHER INFORMATION WAS PROVIDED ON THE BODY TYPE/WEIGHT OF THE PATIENT, WHETHER THE PLACEMENT SITE WAS PREPPED, THE PRECISE POSITION AND ORIENTATION OF THE DISPERSIVE ELECTRODE RELATIVE TO THE SURGICAL AREA, THE DURATION OF THE PROCEDURE AND THE ACTIVATION CYCLE DESPITE REPEATED REQUESTS.

  Patient problems: Burn(s)

  MAUDE report 18235698 ↗
• InjuryFeb 8, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ON JANUARY 10TH, 2023 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A ROBOTIC ASSISTED TOTAL LAPAROSCOPIC HYSTERECTOMY, BILATERAL SALPINGECTOMY, EXCISION, AND FULGURATION OF ENDOMETRIOSIS PROCEDURE WAS PERFORMED AT (B)(6) IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN ERBE GENERATOR EQUIPPED WITH A CQMS HAS BEEN USED. IT IS UNKNOWN WHETHER AND HOW THE PLACEMENT SITE FOR THE DISPERSIVE ELECTRODE WAS PREPPED. THE DISPERSIVE ELECTRODE WAS PLACED ON THE LEFT THIGH. THE PATIENT WAS PUT IN ALLEN STIRRUP POSITION. THE GENERATOR SETTING WAS 3/3/3. WHEN THE DISPERSIVE ELECTRODE WAS REMOVED A BURN (3 ESCHARS) UNDERNEATH THE ELECTRODE WAS DISCOVERED. A PHOTO OF THE INVOLVED ELECTRODE WAS PROVIDED, SHOWING TWO BURNT AREAS AT DIAGONALLY OPPOSED CORNERS OF THE GEL AREA (LEFT TOP AND RIGHT BOTTOM WHEN FACING THE GEL SIDE). THE INJURY WAS TREATED WITH A HYDROCOLLOID OCCLUSIVE DRESSING. NO FURTHER INFORMATION WAS PROVIDED ON THE BODY TYPE/WEIGHT OF THE PATIENT, WHETHER THE PLACEMENT SITE WAS PREPPED, THE PRECISE POSITION AND ORIENTATION OF THE DISPERSIVE ELECTRODE RELATIVE TO THE SURGICAL AREA, THE DURATION OF THE PROC

  Patient problems: Full thickness (Third Degree) Burn

  MAUDE report 16319428 ↗
• InjuryJun 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MAY 25TH, 2022 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A CARDIOVASCULAR PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL (B)(6). A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR HAS BEEN USED. THE INITIAL USER REPORT STATED: "HISTORICAL PERSPECTIVE FROM SURGEON MID APRIL AND EARLY MAY. 4 SEPARATE PATIENTS WITH WOUNDS AFTER THE OR. SUSPICIOUS FOR BURNS. AREAS INCLUDE WHERE THE PAD WAS OR WHERE THE CORDS WERE. NO SIMILARITIES IN PROCEDURES, OR STAFF, GENERATORS, SURGEONS, DIFFERENT LOT NUMBERS, ETC. NO PADS WERE SAVED FOR ANALYSIS. THE SURGEON COULD NOT SPEAK IF A BURN SPECIALIST HAS CONFIRMED IF THIS WAS THERMAL OR CHEMICAL RELATED YET." NO FURTHER INFORMATION WAS PROVIDED DESPITE REPEATED REQUESTS.

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 14752085 ↗
• InjuryJun 21, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON MAY 25TH, 2022 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A CARDIOVASCULAR PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND FT10 AND FORCE FX GENERATORS GENERATOR WERE USED. THE INITIAL USER REPORT STATED: "HISTORICAL PERSPECTIVE FROM SURGEON MID (B)(6) AND EARLY (B)(6). 4 SEPARATE PATIENTS WITH WOUNDS AFTER THE OR. SUSPICIOUS FOR BURNS. AREAS INCLUDE WHERE THE PAD WAS OR WHERE THE CORDS WERE. NO SIMILARITIES IN PROCEDURES, OR STAFF, GENERATORS, SURGEONS, DIFFERENT LOT NUMBERS, ETC. NO PADS WERE SAVED FOR ANALYSIS. THE SURGEON COULD NOT SPEAK IF A BURN SPECIALIST HAS CONFIRMED IF THIS WAS THERMAL OR CHEMICAL RELATED YET." IT WAS ALSO STATED IN THE FORM: "A SINGLE PHOTO ASSOCIATED WITH (B)(4) IS EVALUATED. THE PHOTO, LABELLED AS RIGHT BACK, WAS TAKEN ON 4/14/22. A SLIGHTLY IRREGULAR OVAL AREA OF SKIN LESION IS VISUALIZED. THE AREA SKIN SHOWS MIX OF REGION OF LIGHT DARKNESS AND PATCH OF REDNESS. THE LESION APPEARS LIMITED IN THE SUPERFICIAL LAYER OF SKIN WITH NO SWOLLEN OR BLISTER VISIBLE. THE SKIN LESION IS A FIRST DEGREE BURN APPEARANCE BUT NO UNDERLYING CAUSES CAN B

  Patient problems: Partial thickness (Second Degree) Burn; Superficial (First Degree) Burn

  MAUDE report 14752043 ↗
• MalfunctionJun 21, 2022Energy Output Problem; Device Difficult to Setup or Prepare; Energy Output Problem; Device Difficult to Setup or Prepare

  ON MAY 23TH, 2022 WE HAVE BEEN INFORMED ABOUT A MALFUNCTION INVOLVING A DISPERSIVE ELECTRODE. A HOT SNARE POLYPECTOMY PROCEDURE WAS PERFORMED AT BAPTIST HEALTH HOSPITAL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT MDR REPORT #: MW5109443 WAS FORWARDED BY FDA TO OUR REPRESENTATIVE IN THE US MRS. (B)(6). THE MDR REPORT #: MW5109443 STATED: "PADDED PT WITH CAUTERY GROUND ON RT FLANK FOR HOT SNARE POLYPECTOMY. UPON USE OF SNARE, IT DIDN'T CAUTERIZED THE POLYP AND ENDED UP DOING COLD SNARE ON PT. CHECKED ALL CONNECTIONS AND PRESSED THE GROUND PAD FIRMLY ON PT'S BACK BUT STILL UNABLE TO DO CAUTERIZATION AS INTENDED TO DO. RIGHT FLANK IS DRY AND NO HAIR PRESENT UPON APPLYING THE PAD. ONCE THE PAD IS REMOVED, SITE IS CLEAR, DRY AND INTACT AND THE PAD IS NOTED NOT TO BE AS STICKY AS HAD BEEN IN THE PAST EVEN IF YOU FOLD IT TO STICK BOTH STICKY SIDES TOGETHER, IT DOES NOT STICK ON EACH OTHER AND EASILY SNAP OFF. FDA SAFETY REPORT ID # (B)(4)." NO FURTHER INFORMATION WAS PROVIDED DESPITE REPEATED REQUESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14751964 ↗
• InjuryJun 15, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. AN AORTIC VALVE REPLACEMENT (AVR) AND CORONARY ARTERY BYPASS GRAFTING (CABG) PROCEDURE WAS PERFORMED AT ADVENTHEALTH ORLANDO HOSPITAL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL USER REPORT STATED: "IT WAS REPORTED BY THE SALES REP THAT DURING THE CABG AND AVR PROCEDURE, THE PAD WAS PLACED ON THE PATIENT'S LOWER BACK AND WHEN THEY REMOVED IT, THEY NOTICED THERE WAS A LARGE RED SPOT THERE. THE PATENT HAS BEEN TREATED." NO FURTHER INFORMATION WAS PROVIDED DESPITE REPEATED REQUESTS.

  Patient problems: Superficial (First Degree) Burn

  MAUDE report 14692691 ↗
• MalfunctionApr 29, 2022Energy Output Problem; Device Difficult to Setup or Prepare

  PADDED PT WITH CAUTERY GROUND ON RT FLANK FOR HOT SNARE POLYPECTOMY. UPON USE OF SNARE, IT DIDN'T CAUTERIZED THE POLYP AND ENDED UP DOING COLD SNARE ON PT. CHECKED ALL CONNECTIONS AND PRESSED THE GROUND PAD FIRMLY ON PT'S BACK BUT STILL UNABLE TO DO CAUTERIZATION AS INTENDED TO DO. RIGHT FLANK IS DRY AND NO HAIR PRESENT UPON APPLYING THE PAD. ONCE THE PAD IS REMOVED, SITE IS CLEAR, DRY AND INTACT AND THE PAD IS NOTED NOT TO BE AS STICKY AS HAD BEEN IN THE PAST EVEN IF YOU FOLD IT TO STICK BOTH STICKY SIDES TOGETHER, IT DOES NOT STICK ON EACH OTHER AND EASILY SNAP OFF. FDA SAFETY REPORT ID # (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14257480 ↗
• InjuryDec 20, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6), 2021 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN PROCEDURE WAS PERFORMED AT UNIVERSITY OF (B)(6) HOSPITAL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE USER REPORT STATED: "IT WAS REPORTED BY THE SALES REP [REPRESENTATIVE] THAT DURING AN UNKNOWN PROCEDURE, SURGEON WAS SHOCKED BY ELECTRIC CURRENT WHEN USING BOVIE AND PICK UPS DURING CASE." NO FURTHER INFORMATION WAS PROVIDED DESPITE REPEATED REQUESTS.

  Patient problems: Electric Shock

  MAUDE report 13041992 ↗
• InjuryMay 18, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2021 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A NEUROSURGERY PROCEDURE WAS PERFORMED AT WINCHESTER MEDICAL CENTERL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE USER REPORT STATED: " IT WAS REPORTED BY THE SALES REP THAT DURING A NEUROLOGY CASE WHILE USING TWO 0855C PADS WITH TWO GENERATORS ONE OF THE PADS ALARMED AS IF IT WAS NOT IN GOOD CONTACT WITH THE PATIENT. THE OR STAFF REMOVED PAD AND WAS ABOUT TO REPLACE THE PAD AND THE GENERATOR WAS NOT SHUT OFF, WHILE HOLDING IT THE SURGEON ACTIVATED THE GENERATOR RESULTING IN THREE SMALL BURNS ON HER FINGERS" THE INJURY WAS DESCRIBED AS SMALL BURN. WE HAVE ALSO BEEN INFORMED THAT THERE ARE NO ANTICIPATED LONG-TERM EFFECTS FROM THE BURN AND THE CURRENT STATUS OF THE STAFF MEMBER IS THAT THE INJURIES ARE DOING FINE AND BURN HEALED.

  Patient problems: Burn(s)

  MAUDE report 11839773 ↗
• InjuryMay 26, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A RIGHT PARTIAL MASTECTOMY WITH LYMPH NODE AND NEEDLE LOCALIZATION PROCEDURE WAS PERFORMED AT AN UNKNOWN HOSPITAL IN THE US. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE USER REPORT STATED: " IT WAS REPORTED BY THE SALES REP [REPRESENTATIVE] THAT DURING A RIGHT PARTIAL MASTECTOMY W[ITH] LYMPH NODE AND NEEDLE LOCALIZATION AN ARCHING ELECTRICAL CURRENT JUMPED FROM THE PENCIL AND BURNED THE PATIENT. IT IS UNKNOWN HOW THE CASE WAS COMPLETED. ONE DEVICE WILL BE RETURNED."

  Patient problems: Burn(s)

  MAUDE report 10086457 ↗
• InjuryMay 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A LAPAROSCOPIC LYSIS OF ADHESIONS PROCEDURE WAS PERFORMED AT AN UNKNOWN HOSPITAL. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE USER REPORT STATED: " IT WAS REPORTED BY THE REP [REPRESENTATIVE] POST OPERATIVE A LAPAROSCOPIC LYSIS OF ADHESIONS THAT WAS CONVERTED TO AN OPEN INCARCERATED VENTRAL HERNIA. THE PATIENT EXPERIENCED SKIN IRRITATION. UNKNOWN HOW THE IRRITATION WAS ADDRESSED. THE DEVICE WILL BE RETURNED."

  Patient problems: Skin Irritation

  MAUDE report 10069466 ↗
• InjuryMay 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. AN UNKNOWN SURGICAL PROCEDURE WAS PERFORMED AT AN UNKNOWN HOSPITAL. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE USER REPORT STATED: " IT WAS REPORTED BY THE SALES REP [REPRESENTATIVE] THAT DURING AN UNKNOWN PROCEDURE THE PATIENT 'WAS BRUISED BY THE BOVI PAD [DISPERSIVE ELECTRODE]'. IT IS UNKNOWN IF OR HOW THE PATIENT WAS TREATED. ONE DEVICE WILL BE RETURNED."

  Patient problems: Bruise/Contusion

  MAUDE report 10069461 ↗
• InjuryMay 19, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2020 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A COLOSTOMY REVERSAL SURGICAL PROCEDURE WAS PERFORMED AT AN UNKNOWN HOSPITAL. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE USER REPORT STATED: "IT WAS REPORTED (...) AFTER A COLOSTOMY REVERSAL THE PATIENT EXPERIENCED SKIN IRRITATION AFTER THE PAD [DISPERSIVE ELECTRODE] WAS REMOVED. IT IS UNKNOWN HOW THE CONDITION WAS ADDRESSED (...)."

  Patient problems: Skin Irritation

  MAUDE report 10069455 ↗
• MalfunctionDec 5, 2019No Device Output; No Device Output

  ON NOVEMBER 09TH, 2019 WE HAVE BEEN INFORMED ABOUT AN INCIDENT INVOLVING A DISPERSIVE ELECTRODE. A CAUTERIZE VESSELS ROBOTIC HYSTERECTOMY SURGICAL PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL IN (B)(6) 2019. A MEGADYNE DISPERSIVE ELECTRODE CATALOG NUMBER 0855C (OUR MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT WAS PROVIDED WITH THE USER'S MED WATCH REPORT NUMBER: # (B)(4). THE USER REPORT STATED: "ELECTROSURGICAL UNIT WAS IN USE TO CAUTERIZE VESSELS DURING ROBOTIC HYSTERECTOMY. MEGADYNE ELECTROSURGICAL PATIENT RETURN ELECTREODE IN PLACE. WHEN SURGEON WENT TO USE THE ESU, IT ALARMED. PAD WAS NOT ADHERING TO PATIENT THEREFORE THE ESU WOULD NOT OPERATE. THE SURGEON WAS ENCOUNTERING BLEEDING AND NEEDED ESU TO OPERATE. THE RETURN ELECTRODE PADS FROM THIS COMPANY HAVE BEEN ROUTINELY NOT ADHERING TO THE PATIENT CAUSING THIS ISSUE REPETITIVELY. PAD WAS CHECKED BY CIRCULATOR AND COMPRESSED AND ESU WOULD THEN OPERATE AND VESSEL WAS CAUTERIZED.". THE DISTRIBUTOR FURTHER STATED "THERE WERE NO PATIENT CONSEQUENCES REPORTED. THE DEVICE IS NOT AVAILABLE FOR RETURN.". WE HAVE REQUESTED SEVERAL TIMES FOR ADDTIONAL INFORMATION AND HAVE NOT RECEIVED ANY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9414968 ↗
• InjuryMay 15, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ON APRIL 15TH, 2019 AN ENT [EAR NOSE THROAT] PROCEDURE WAS PERFORMED AT AN UNKNOWN HOSPITAL. A MONITORING DISPERSIVE ELECTRODE (MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORTER STATED: "IT WAS REPORTED BY THE SALES REP THAT DURING AN ENT PROCEDURE, IT WAS A BOVIE PAD [DISPERSIVE ELECTRODE] 0855C, ACCORDING TO THE NURSE, WHEN THEY REMOVED THE PAD, PART OF THE SKIN CAME OFF OF THE PATIENT, AND THEY DID NOT NOTICE UNTIL THE END OF THE PROCEDURE WHEN THEY WERE REMOVING THE PAD." REQUESTING ADDITIONAL INFORMATION WE RECEIVED THE INFORMATION THAT "I DO NOT KNOW HOW THE PATIENT IS DOING. AFTER THE INCIDENT, SURGEON ORDERED BACITRACIN OINTMENT TO THE SITE. NO FURTHER INFORMATION KNOWN."

  Patient problems: Skin Tears

  MAUDE report 8611683 ↗
• InjuryNov 22, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 A SPINAL PROCEDURE WAS PERFORMED AT (B)(6) MEDICAL CENTER, (B)(6). A MONITORING DISPERSIVE ELECTRODE (MODEL RS271A30) AND AN UNKNOWN GENERATOR WERE USED. THE INITIAL REPORT STATED "IT WAS REPORTED BY THE SALES REP THAT POST OP OF A SPINAL PROCEDURE, REPORTED REACTION TO RETURN ELECTRODE PAD. PATIENT HAS RASH AT SITE OF RETURN ELECTRODE PAD. (...) NO INTRA-OPERATIVE ISSUES." IT WAS ALSO STATED BY THE INITIAL REPORTER "HOW WAS THE RASH TREATED? UNKNOWN." WE RECEIVED PHOTOS SHOWING THE PATIENT INJURY. WE ASSUME THE PICTURE IS SHOWING A PART OF THE RIGHT THIGH WITH A LINE OF RED SPOTS LIKE A BRUISE.

  Patient problems: Rash; Skin Irritation

  MAUDE report 8098439 ↗
• InjuryOct 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ON (B)(6) 2018 A GYNECOLOGICAL PROCEDURE WAS PERFORMED AT (B)(6) HOSPITAL (B)(6). A MONITORING DISPERSIVE ELECTRODE (MODEL RS271A30) AND A REM EQUIPPED COVIDIEN FORCE TRIAD GENERATOR WERE USED. THE INITIAL REPORT STATED "THAT DURING A VAGINAL BIOPSY, AFTER THE PROCEDURE WAS COMPLETED, THE OR TECH HAD TO USE TWO HANDS TO REMOVE THE PATIENT RETURN PAD FROM THE UPPER RIGHT LATERAL LEG OF THE PATIENT, AND NOTICED THERE WAS FIRST LAYER SKIN REMOVAL, REDNESS AND IRRITATION WHEN THE PAD WAS REMOVED. THE DOCTOR HAD USED A COVIDIEN FORCE TRIAD GENERATOR, SET TO 30 WATTS CUT AND COAG, DURING THE PROCEDURE AND ACTIVATED THE GENERATOR TWO OR THREE TIMES. IT WAS NOT REPORTED HOW THE REDNESS AND IRRITATION WAS TREATED."

  Patient problems: Skin Irritation; Skin Tears

  MAUDE report 7977071 ↗