Sonicision 7Recalls & reported problems across all models
Covidien LP · 5 models in the FDA device registry
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 162
- Deaths reported
- 0
- Injuries reported
- 27
- Recalls
- 0
We found 5 models of Sonicision 7 by Covidien LP in the FDA's device registry (GUDID). Together they are named in 162 adverse event reports in the FDA's MAUDE database, received between Sep 8, 2022 and Sep 21, 2026 — classified as 27 injuries, 135 malfunctions.
The most frequently reported specific device problem is “Detachment of Device or Device Component” (97 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works
Reports received per month, all models
Most reported Sonicision 7 problems
Device problems
- Detachment of Device or Device Component97
- Failure to Fire48
- Adverse Event Without Identified Device or Use Problem32
- Self-Activation or Keying20
- Naturally Worn9
- Break8
- Device Remains Activated7
- Failure to Deliver Energy7
Patient problems
- No Clinical Signs, Symptoms or Conditions120
- Hemorrhage/Blood Loss/Bleeding28
- Unintended Radiation Exposure11
- Insufficient Information8
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Burn(s)4
- Tissue Breakdown4
- Abdominal Pain3
Sonicision 7 models
5 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Sonicision 7 SCD7A39Instrument, ultrasonic surgical112 reports
- Sonicision 7 SCD7A48Instrument, ultrasonic surgical17 reports
- Sonicision 7 SCG7ABInstrument, ultrasonic surgical15 reports
- Sonicision 7 SCD7A26Instrument, ultrasonic surgical13 reports
- Sonicision 7 SCD7A13Instrument, ultrasonic surgical5 reports
Recent Sonicision 7 adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionSep 21, 2026Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848982 ↗MalfunctionSep 21, 2026Self-Activation or Keying
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50848952 ↗MalfunctionAug 28, 2026Failure to Fire; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50493618 ↗MalfunctionAug 25, 2026Material Separation; Failure to Fire; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50435384 ↗MalfunctionJul 31, 2026Failure to Fire; Detachment of Device or Device Component
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50099830 ↗MalfunctionMay 12, 2026Failure to Deliver Energy; Difficult or Delayed Activation; Failure to Cut; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING A LAPAROSCOPIC PARAESOPHAGEAL HERNIA REPAIR, THE DEVICE'S WHITE TEFLON AT THE JAW WAS SLIDING IN AND OUT AND APPEARED TO BE COMING OFF. THE SURGEON MENTIONED THAT IT WAS TAKING MORE TIME THAN USUAL TO CUT AND BURN THE TISSUE. A NEW DEVICE WAS OPENED.
Patient problems: Insufficient Information
MAUDE report 25149599 ↗MalfunctionApr 21, 2026Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR WOULD NOT ACTIVATE. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INS TRUMENTS. A PART OF THE DISSECTOR HAD COMPLETELY DETACHED FROM THE DEVICE BUT IT DID NOT FELL INTO THE PATIENT'S CAVITY. X-RAY WAS NOT NECESSARY AND THERE WAS FULL PRODUCT COUNT. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24940489 ↗MalfunctionApr 14, 2026Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE, THE DEVICE WAS USABLE AT FIRST BUT PARTWAY THROUGH IT WAS NO LONGER ABLE TO OUTPUT. THE BATTERY WAS REPLACED BUY THE BATTERY STILL COULD NOT BE USED AND SO THE DEVICE WAS REPLACED WITH A NEW ONE. NO PART OF THE DISSECTOR BROKE. THERE WAS NO PATIENT HARM/INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THE DISSECTOR HAD A FRACTURED WAVEGUIDE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24872953 ↗MalfunctionApr 11, 2026Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE, THE DISSECTOR WOULD NOT ACTIVATE. THE DISSECTOR WAS REPLACED WITH A NEW ONE AND THE SURGERY WENT WELL. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR WAS BROKEN OFF AND RETURNED. USE AFTER DAMAGE CAN CAUSE THE CRACKED WAVEGUIDE TO BREAK OFF.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24847447 ↗MalfunctionApr 3, 2026Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE, THE SURGERY STARTED WITH THE CLAMP AND IT WORKED WELL, AFTER A WHILE, THE GENERATOR SHOWED A RED LIGHT, IT WAS DISASSEMBLED AND REASSEMBLED AND THE ERROR PERSISTS, THE GENERATOR AND BATTERY WERE CHANGED AND IT CONTINUED TO SHOW RED; THE CLAMP WAS CHANGED AND EVERYTHING WORKED. NO PART OF THE DISSECTOR BROKE. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION FOUND THAT THE DEVICE SHOWED EVIDENCE OF USE. DEBRIS WAS NOTED UNDER THE ACTIVATION BUTTON.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24777893 ↗MalfunctionMar 31, 2026Tear, Rip or Hole in Device Packaging; Detachment of Device or Device Component
IT WAS REPORTED THAT PRIOR TO USE, THE DISSECTOR HAD PACKAGING ISSUE. IT WAS APPEARING DAMAGED OR TORN. THE DEVICE DID NOT BREAK DURING PROCEDURE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE DEVICE SHOWED EVIDENCE OF USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24739878 ↗MalfunctionMar 18, 2026Device Difficult to Setup or Prepare; Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT DURING PROCEDURE, THERE WAS A SLIGHT DISCOMFORT WHEN CONNECTING AND THE DEVICE WAS USED AS IS BUT AFTER ABOUT 2 HOURS RED LIGHT TURNED ON AND IT COULD NOT BE USED. THE BATTERY WAS REPLACED BUT THE ISSUE WAS NOT RESOLVED. THE DISSECTOR AND GENERATOR WAS ATTEMPTED TO BE DETACHED FROM EACH OTHER BUT THEY COULD NOT BE DETACHED. ANOTHER DEVICE WAS TAKEN OUT AND USED. A DISTRIBUTOR'S REPRESENTATIVE USED TOOLS TO DETACH THE DISSECTOR AND GENERATOR. AFTERWARDS THE GENERATOR WAS CONNECTED TO ANOTHER DISSECTOR AND COULD BE USED WITHOUT ISSUES. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENT. ANOTHER DISSECTOR WAS USED WITH THE SAME GENERATOR AND BATTERY AND WORKED FINE. THE CONNECTION PART BETWEEN THE DISSECTOR AND GENERATOR BROKE. IT WAS COMPLETELY REMOVED AND DID NOT FALL INTO THE PATIENT'S CAVITY. THERE WAS NO PATIENT HARM/INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24629159 ↗MalfunctionMar 16, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING LAPAROSCOPIC MYOMECTOMY, THE FIRST DEVICE'S BLADE SNAPPED OFF INTO THE PATIENT. A SECOND DEVICE WAS OPENED, AND THE CASE CONTINUED, BUT A RED ERROR TONE BEGAN APPROXIMATELY 20 MINUTES INTO ITS USE. THEY PROCEEDED TO OPEN THREE MORE DEVICES, ALL OF WHICH CONTINUED TO EMIT ERROR TONES. THE BROKEN PIECE WAS RETRIEVED AND REMOVED WITHOUT THE USE OF AN X-RAY. THERE WAS NO PATIENT HARM/INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24607819 ↗MalfunctionMar 12, 2026Detachment of Device or Device Component
IT WAS REPORTED THAT DURING USE, THE DEVICE'S TIP BROKE OFF.
Patient problems: Insufficient Information
MAUDE report 24577720 ↗MalfunctionMar 7, 2026Failure to Fire; Detachment of Device or Device Component
IT WAS REPORTED THAT, DURING PROCEDURE, THE DISSECTOR WAS ASSEMBLED SUCCESSFULLY WITH A GREEN LIGHT, CONFIRMING GOOD STATUS. UPON INITIAL ACTIVATION THE DISSECTOR HAD SWITCHED OFF COMPLETELY AND WAS NOT INTRODUCED TO THE PATIENT CAVITY. THE DISSECTOR DID NOT BREAK. THE SAME GENERATOR AND BATTERY WERE USED ON THE SECOND DISSECTOR AND THEY WORKED PERFECTLY. THE DISSECTOR DID NOT COME INTO CONTACT WITH ANY METAL INSTRUMENTS. THERE WAS NO PATIENT INJURY. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE DISSECTOR HAD A FRACTURED WAVEGUIDE. THE WAVEGUIDE WAS NOT RETURNED WITH THE DEVICE. THE DEVICE MALFUNCTIONED AFTER ASSEMBLY BEFORE IT WAS INTRODUCED INSIDE THE PATIENTS CAVITY. THE DEVICE WAS NOT INTRODUCED INSIDE THE PATIENTS CAVITY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24541194 ↗
Other Covidien LP products
- Endo GIA48 models · 26,277 reports · 8 recalls
- Endo GIA Ultra3 models · 15,650 reports
- Shiley387 models · 9,392 reports · 5 recalls
- Signia16 models · 8,201 reports · 6 recalls
- LigaSure32 models · 7,283 reports · 1 recall
- Tri-Staple 2.037 models · 4,892 reports · 2 recalls
- Polysorb291 models · 4,564 reports · 2 recalls
- EEA39 models · 4,432 reports · 1 recall
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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