Surgiwand IIRecalls & reported problems across all models
Covidien LP · 6 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
1 open recall names at least one Surgiwand II model. Check whether yours is affected in the recall details, and contact the manufacturer or your healthcare provider.
- Adverse event reports
- 196
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls
- 1
We found 6 models of Surgiwand II by Covidien LP in the FDA's device registry (GUDID). Together they are named in 196 adverse event reports in the FDA's MAUDE database, received between Jun 7, 2016 and Feb 4, 2025 — classified as 14 injuries, 182 malfunctions.
The most frequently reported specific device problem is “Break” (105 reports).
1 FDA recall record name at least one of these models by its device identifier, 1 still open.
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
Surgiwand II recalls
FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.
- Mar 5, 2021Open, Classified
Investigations related to customer complaints received for particulate matter inside of the Surgiwand" II device tubing components identified the root cause as a damaged Y-Connector component which connects the tubing to the device. This damage was determined to generate the particulate matter observed and is created during the assembly process for connecting the tubing component to the Y-Connector.
Z-1411-2021 · Root cause: Process design · names 3 of these models · Recall details · FDA record ↗
Most reported Surgiwand II problems
Device problems
- Break105
- Melted60
- Detachment of Device or Device Component31
- Sparking17
- Device Slipped8
- Flare or Flash8
- Material Split, Cut or Torn5
- Mechanical Problem5
Patient problems
- No Clinical Signs, Symptoms or Conditions97
- No Known Impact Or Consequence To Patient32
- No Consequences Or Impact To Patient31
- Insufficient Information18
- No Patient Involvement17
- No Code Available6
- Burn(s)5
- No Information5
Surgiwand II models
6 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Surgiwand II 178093ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall83 reports
- Surgiwand II 178091ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES84 reports
- Surgiwand II 178094ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall10 reports
- Surgiwand II 178083ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES1 recall5 reports
- Surgiwand II 178099ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES11 reports
- Surgiwand II 178081ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES3 reports
Recent Surgiwand II adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionFeb 4, 2025Break; Break
IT WAS REPORTED THAT PRIOR TO USE, THE DISTAL TIP OF THE BLACK SHEATH OF THE DEVICE WITH CAUTERY WAS DAMAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE.
Patient problems: Insufficient Information
MAUDE report 21305924 ↗MalfunctionJan 21, 2025Melted; Melted
IT WAS REPORTED THAT PREOPERATIVELY, THE DISTAL TIP OF THE BLACK SHEATH OF THE SURGIWAND WAS DAMAGED AND APPEARED TO BE MELTED. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21201293 ↗MalfunctionJul 1, 2024Melted; Melted
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LIVER METASTASECTOMY, AT THE TIME OF USING THE DEVICE IN THE ABDOMINAL CAVITY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED; IT WAS MELTED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19645211 ↗MalfunctionMar 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE SHAFT OF THE DEVICE WAS SEPARATED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 18859176 ↗MalfunctionSep 25, 2023Break; Break
ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17812476 ↗MalfunctionSep 14, 2023Break; Break
ACCORDING TO THE REPORTER, THE TIP OF THE DEVICE WAS BROKEN. NO PATIENT WAS INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17745701 ↗MalfunctionSep 12, 2023Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A TRANSVAGINAL HYDRO LAPAROSCOPY (THL) PROCEDURE, WHEN ACTIVATION OF THE ELECTRODE, THE INSTRUMENT MELTED AND THE PLASTIC COATING FELL INTO THE PATIENT'S CAVITY. THE PLASTIC COATING WAS RETRIEVED WITH FORCEPS. IT WAS OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, THE PROCEDURE WAS CONTINUED WITHOUT THE DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17731136 ↗MalfunctionSep 12, 2023Melted; Detachment of Device or Device Component; Melted; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A TRANSVAGINAL HYDRO LAPAROSCOPY (THL) PROCEDURE, WHEN ACTIVATION OF THE ELECTRODE, THE INSTRUMENT MELTED AND THE PLASTIC COATING FELL INTO THE PATIENT'S CAVITY. THE PLASTIC COATING WAS RETRIEVED WITH FORCEPS. IT WAS OCCURRED ON TWO DEVICES. TO RESOLVE THE ISSUE, THE PROCEDURE WAS CONTINUED WITHOUT THE DEVICE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17730336 ↗MalfunctionAug 29, 2023Sparking; Sparking
ACCORDING TO THE REPORTER, PREOPERATIVELY, AN UNEXPECTED SPARK WAS FOUND AND OCCURRED. AN EXCHANGE OF DEVICE WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17644065 ↗MalfunctionAug 4, 2023Melted; Melted
ACCORDING TO THE REPORTER, PREOPERATIVELY, THE DEVICE HAD MELTED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17464110 ↗MalfunctionJul 10, 2023Break; Sparking; Detachment of Device or Device Component; Material Twisted/Bent; Break; Sparking; Detachment of Device or Device Component; Material Twisted/Bent
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, AT CAUTERIZATION OF LIVER BED, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED AND BROKEN PIECE OF THE SHAFT FELL IN THE ABDOMEN. THE BROKEN PIECE WAS RETRIEVED USING LAPAROSCOPIC GRASPERS. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 17292310 ↗MalfunctionMay 23, 2023Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THE FRONT TIP PART OF THE DEVICE FELL OFF, NOT INTO THE PATIENT CAVITY. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16988890 ↗MalfunctionDec 13, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
ACCORDING TO THE REPORTER, THE SHAFT CAME OUT BY ITSELF. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15970987 ↗MalfunctionNov 8, 2022Break; Break
ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED.
Patient problems: Insufficient Information
MAUDE report 15751499 ↗MalfunctionOct 3, 2022Melted; Melted
ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA SURGERY, THE THREE DEVICES HAD MELTED PLASTIC ENDS. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15533170 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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