Sonicision SCD396 (UDI 20884521052663)Recalls & reported problems

Summary

The FDA's MAUDE database contains 675 adverse event reports that list this exact device (DI 20884521052663), received between May 23, 2016 and Jul 3, 2023 — classified as 1 death, 64 injuries, 610 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (321 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 675 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2023Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE RED LIGHT PROMPTED AFTER THE JAW WAS CLOSED AND WAS ACTIVATED. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. THERE WAS NO DETACHED PART FELL ON PATIENT'S CAVITY. A NEW DISSECTOR WAS USED AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17251748 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, AFTER THE JAW WAS CLOSED, IT WAS ACTIVATED, AND THE RED LIGHT PROMPTED. REPLACED WITH A NEW DISSECTOR TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT: DEVICE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED. NOTHING FELL INTO PATIENT'S CAVITY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238297 ↗
• MalfunctionJun 30, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE ACTIVATE WHEN JAWS ARE CLOSED, RED LIGHT CUES. THE PART WAS NOT DETACHED FROM THE DEVICE. A NEW/ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED FINE. THERE WAS NO DETACHED PIECE THAT FELL INTO THE PATIENT¿S CAVITY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17238232 ↗
• MalfunctionJun 29, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE REMAINED ACTIVATED IN THE PRESENCE OF USER INPUT. THE JAWS WERE CLOSED THEN THE RED LIGHT INDICATED. WHEN THE DISSECTOR WAS NOT USED, THE RESIDUAL TISSUE OF THE DISSECTOR WAS INVOLVED IN CLEANING, AND THE ISSUE WAS FOUND. USED THE SAME GENERATOR AND BATTERY AND REPLACED WITH A NEW ULTRASOUND KNIFE TO OPERATE WELL. THE DEVICE DID NOT BREAK DURING SURGERY AND DURING CLEANING. NOTHING FELL ON THE PATIENT'S CAVITY. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE REVEALED THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17225581 ↗
• MalfunctionJun 28, 2023Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AFTER THE JAW WAS CLOSED, IT WAS ACTIVATED, AND THE RED LIGHT PROMPTED. THE DISSECTOR DID NOT CAME INTO CONTACT WITH ANY METAL INSTRUMENTS AND NO PART OF THE DISSECTOR WAS DETACHED. A NEW DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND IT WORKED FINE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: Insufficient Information

  MAUDE report 17221390 ↗
• MalfunctionDec 28, 2022Self-Activation or Keying; Failure to Fire; Self-Activation or Keying; Failure to Fire

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE PROBLEM WAS ENCOUNTERED DURING THE TIME INTERVAL WHEN THE DEVICE WAS NOT IN USE ON A PATIENT AND WAS BEING CLEANED DURING SURGERY, IT WAS FIRED AFTER THE JAWS WERE CLOSED AND A RED LIGHT INDICATED THE PROBLEM. A NEW DEVICE WAS USED AND IT WORKED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 16064636 ↗
• MalfunctionDec 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE DEVICE BROKE DURING USE ON A PATIENT, THE TIP OF SEALANT BROKE OFF. THERE SURGERY WAS FURTHER PROLONGED, AS THEY HAVE TO MAKE SURE THAT THE BROKEN TIP WAS NOT INSIDE THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15898142 ↗
• InjuryNov 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE DEVICE BROKE DURING USE ON A PATIENT. DURING USE OF SONICISION, THE TIP (ACTIVE) WAS MITED TO BE MISSING. DISSECTION OF THE ABDOMEN REVEALED TIP ON THE ABDOMINAL CAVITY. SERIOUS ILLNESS INJURY.

  Patient problems: Foreign Body In Patient

  MAUDE report 15834238 ↗
• InjuryOct 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PED APPENDECTOMY, THE DEVICES' UPPER JAW WAS MISSING BUT NO ALARM OR ANY INDICATION WHEN ASSEMBLED. THE CUSTOMER DID NOT APPLY POWER TO THE DEVICE. AS SOON AS THEY INTRODUCE IT THROUGH THE TROCAR, THEY SAW (ON SCREEN) THAT THE DEVICE WAS MISSING THE UPPER JAW WHICH WAS THE ENTIRE MOVABLE JAW. A MEDICAL OR SURGICAL INTERVENTION WAS NEEDED WHEREIN THEY PERFORMED AN X-RAY TO PREVENT PERMANENT IMPAIRMENT AND TO DETECT THE MISSING JAW BUT THEY DID NOT FIND ANYTHING. IT WAS DONE WHILE THE PATIENT WAS UNDER ANESTHESIA. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PHOTO ATTACHED WAS SHOWING THAT THE UPPER PART OF THE DEVICE'S JAW WAS MISSING. THE PATIENT IS NOW DOING OKAY.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unintended Radiation Exposure

  MAUDE report 15695822 ↗
• InjuryOct 21, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, TWO DEVICES' UPPER JAW WAS MISSING BUT NO ALARM OR ANY INDICATION WHEN ASSEMBLED. A MEDICAL OR SURGICAL INTERVENTION WAS NEEDED WHEREIN THEY PERFORMED AN X-RAY TO PREVENT PERMANENT IMPAIRMENT AND TO DETECT THE MISSING JAW BUT THEY DID NOT FIND ANYTHING. IT WAS DONE WHILE THE PATIENT WAS UNDER ANESTHESIA. THE PHOTO ATTACHED WAS SHOWING THAT THE UPPER PART OF THE DEVICE'S JAW WAS MISSING.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Unintended Radiation Exposure

  MAUDE report 15652018 ↗
• MalfunctionOct 12, 2022Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS NOT WORKING. WHEN THEY WERE ABOUT TO USE THE DEVICE, IT DID NOT SHOW GREEN L IGHT. ANOTHER DEVICE WAS USED AND WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15591643 ↗
• MalfunctionOct 5, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Difficult or Delayed Activation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE ACTIVATION ISSUE WHEREIN IT WAS DIFFICULT TO ACTIVATE AND HAD AN INTERMITTENT ACTIVATION. REPLACING WITH ANOTHER SET OF GENERATOR AND BATTERY, DISSECTOR TIP STILL COULD NOT BE ACTIVATED NORMALLY. REPLACING WITH A DISSECTOR TIP, AND ASSEMBLY WITH THE ORIGINAL GENERATOR AND BATTERY COULD BE ACTIVATED AND USED NORMALLY. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15544302 ↗
• MalfunctionAug 26, 2022Difficult or Delayed Activation; Detachment of Device or Device Component; Intermittent Energy Output; Difficult or Delayed Activation; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE COULDN'T BE FIRED, DIFFICULT TO ACTIVATE, OR FIRED INTERMITTENTLY AFTER INSTALLATION. REPLACED BATTERY AND GENERATOR, BUT IT STILL DIDN'T WORK. A NEW/ANOTHER DISSECTOR USED WITH THE SAME BATTERY AND GENERATOR WAS USED AND IT WORKED FINE. IT WAS REPORTED THAT THE FRACTURED TIP DID NOT ENTER THE PATIENT'S BODY AS THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED/DISENGAGED AND THE BROKEN PIECE WAS NOT RETURNED. THE REPORTED CONDITION OF NO ACTIVATION PRIOR TO USE COULD NOT BE CONFIRMED, BECAUSE THE DEVICE SHOWED EVIDENCE OF USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15306310 ↗
• MalfunctionAug 15, 2022Detachment of Device or Device Component; Intermittent Energy Output; Detachment of Device or Device Component; Intermittent Energy Output

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WAS DIFFICULT TO ACTIVATE. THEY USED ANOTHER DISSECTOR AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15228546 ↗
• MalfunctionAug 11, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE BROKE DURING USE ON A PATIENT. THERE WAS NO PATIENT INJURY. THE MEDTRONIC INITIAL VISUAL INSPECTION FOUND OUT THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15211237 ↗
• MalfunctionJul 13, 2022Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information; Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WERE SIX HANDPIECES THAT WORKED WITHIN 20 MINUTES, THEN THE WORKING BRANCH ON ALL OF THEM BROKE OFF, AND THEY SHOWED A RED LIGHT. THE DISSECTOR WAS WORKING FINE BEFORE THE DISENGAGEMENT OF THE PIECE AND THE ACTIVE BLADE DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE HELP OF SCISSORS AND BIPOLAR. ULTRASOUND WILL BE PERFORMED SOON AS PART OF ROUTINE TEST DUE TO PATIENT'S CONDITION AND TO CHECK IF THERE'S ANY PIECE LEFT ON PATIENT'S BODY BUT NO OTHER ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006982 ↗
• MalfunctionJul 13, 2022Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information; Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THERE WERE SIX HANDPIECES THAT WORKED WITHIN 20 MINUTES, THEN THE WORKING BRANCH ON ALL OF THEM BROKE OFF, AND THEY SHOWED A RED LIGHT. THE DISSECTOR WAS WORKING FINE BEFORE THE DISENGAGEMENT OF THE PIECE AND THE ACTIVE BLADE DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE HELP OF SCISSORS AND BIPOLAR. ULTRASOUND WILL BE PERFORMED SOON AS PART OF ROUTINE TEST DUE TO PATIENT'S CONDITION AND TO CHECK IF THERE'S ANY PIECE LEFT ON PATIENT'S BODY BUT NO OTHER ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15006755 ↗
• MalfunctionJul 13, 2022Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information; Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDPIECES WORKED WITHIN 20 MINUTES, THEN THE WORKING BRANCH BROKE OFF AND SHOWED A RED LIGHT. THE DISSECTOR WAS WORKING FINE BEFORE THE DISENGAGEMENT OF THE PIECE AND THE ACTIVE BLADE DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE HELP OF SCISSORS AND BIPOLAR. ULTRASOUND WILL BE PERFORMED SOON AS PART OF ROUTINE TEST DUE TO PATIENT'S CONDITION AND TO CHECK IF THERE IS ANY PIECE LEFT ON PATIENT'S BODY BUT NO OTHER ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15002752 ↗
• MalfunctionJul 13, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDPIECES WORKED WITHIN 20 MINUTES, THEN THE WORKING BRANCH BROKE OFF AND SHOWED A RED LIGHT. THE DISSECTOR WAS WORKING FINE BEFORE THE DISENGAGEMENT OF THE PIECE AND THE ACTIVE BLADE DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE HELP OF SCISSORS AND BIPOLAR. ULTRASOUND WILL BE PERFORMED SOON AS PART OF ROUTINE TEST DUE TO PATIENT'S CONDITION AND TO CHECK IF THERE IS ANY PIECE LEFT ON PATIENT'S BODY BUT NO OTHER ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15001438 ↗
• MalfunctionJul 13, 2022Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information; Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDPIECES WORKED WITHIN 20 MINUTES THEN THE WORKING BRANCH BROKE OFF AND SHOWED A RED LIGHT. THE DISSECTOR WAS WORKING FINE BEFORE THE DISENGAGEMENT OF THE PIECE AND THE ACTIVE BLADE DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE HELP OF SCISSORS AND BIPOLAR. ULTRASOUND WILL BE PERFORMED SOON AS PART OF ROUTINE TEST DUE TO PATIENT'S CONDITION AND TO CHECK IF THERE'S ANY PIECE LEFT ON PATIENT'S BODY BUT NO OTHER ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000507 ↗
• MalfunctionJul 13, 2022Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information; Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDPIECES WORKED WITHIN 20 MINUTES THEN THE WORKING BRANCH BROKE OFF AND SHOWED A RED LIGHT. THE DISSECTOR WAS WORKING FINE BEFORE THE DISENGAGEMENT OF THE PIECE AND THE ACTIVE BLADE DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE HELP OF SCISSORS AND BIPOLAR. ULTRASOUND WILL BE PERFORMED SOON AS PART OF ROUTINE TEST DUE TO PATIENT'S CONDITION AND TO CHECK IF THERE'S ANY PIECE LEFT ON PATIENT'S BODY BUT NO OTHER ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15000375 ↗
• MalfunctionJul 12, 2022Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information; Failure to Fire; Detachment of Device or Device Component; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE HANDPIECE'S WORKING BRANCH BROKE OFF AND SHOWING A RED LIGHT. THE SURGICAL TEAM AND NURSING STAFF HAD TO SPEND TIME LOOKING FOR A BROKEN BRANCH. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METALLIC INSTRUMENT OR OBJECT DURING THE PROCEDURE. PROCEDURE WAS COMPLETED WITH THE HELP OF SCISSORS AND BIPOLAR. ALL PIECES WERE RETRIEVED, NOTHING FELL ON PATIENT CAVITY AND NO ADDITIONAL MEDICAL INTERVENTION WAS PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14992638 ↗
• MalfunctionJul 5, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE DEVICE WAS DAMAGED DURING USE ON PATIENT. NOTHING COMPLETELY BROKE OFF FROM THE DEVICE. BASED ON THE INVESTIGATION, THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14916327 ↗
• MalfunctionJun 21, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPY, THE DEVICE STOPPED WORKING. ANOTHER BATTERY WAS INSTALLED ONTO THE HANDPIECE AND NO ERROR TONES WERE HEARD OR RED LIGHTS OBSERVED. NO PART OF THE DISSECTOR BROKE OFF. PROCEDURE WAS COMPLETED BY REPLACING ANOTHER DEVICE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14754919 ↗
• MalfunctionJun 20, 2022Failure to Fire; Detachment of Device or Device Component; Failure to Fire; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TWEEZERS WERE RELEASED AND HAD A RED ALERT. THE DEVICE STOPPED WORKING AT THE SAME TIME. IT WAS REPORTED THAT ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR/BATTERY AND WORKED FINE. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE TIP OF THE WAVEGUIDE HAD FRACTURED AND DISENGAGED. THE BROKEN PIECE WAS NOT RETURNED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14744666 ↗