Surgiwand II 178099Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884523000931), received between Jan 18, 2018 and Mar 7, 2024 — classified as 1 injury, 10 malfunctions.

The most frequently reported specific device problem is “Break” (4 reports).

1 other recall cover devices cleared under the same FDA submission (K961771); 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• 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 ↗
• MalfunctionSep 28, 2022Melted; Melted

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TIP OF THE DEVICE MELTED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498112 ↗
• MalfunctionAug 3, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC ANTERIOR RESECTION, WHEN SUCTIONING OF FLUID, THE DISTAL TIP OF THE BLACK SHEATH GOT DAMAGED. A NEW PIECE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15161608 ↗
• MalfunctionMar 25, 2022Sparking; Sparking

  ACCORDING TO THE REPORTER, THE ENERGY LEAKED FROM THE TIP.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 13900971 ↗
• MalfunctionApr 13, 2021Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE'S DISTAL TIP OF THE BLACK SHEATH DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11661021 ↗
• InjuryMay 14, 2020Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, DURING IRRIGATION OF ABDOMINAL CAVITY ON A LAPAROSCOPIC APPENDECTOMY, IT WAS NOTED THAT THERE WAS A FOREIGN OBJECT THAT CAME FROM THE DEVICE THAT FELL INTO PATIENT'S CAVITY.

  Patient problems: No Code Available

  MAUDE report 10058293 ↗
• MalfunctionMay 13, 2020Detachment of Device or Device Component; Device Contamination with Chemical or Other Material; Detachment of Device or Device Component; Device Contamination with Chemical or Other Material

  ACCORDING TO THE REPORTER, DURING IRRIGATION OF ABDOMINAL CAVITY ON A LAPAROSCOPIC CHOLECYSTECTOMY, THERE WAS A FOREIGN UNIDENTIFIED MATERIAL FOUND ON THE DEVICE THAT FELL INTO THE PATIENT'S CAVITY AND WAS RETRIEVED BY A GRASPER. SURGEON USED ANOTHER DEVICE TO RESOLVE THE ISSUE.

  Patient problems: No Information

  MAUDE report 10053356 ↗
• MalfunctionAug 8, 2019Melted; Melted

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TIP PART OF THE DEVICE WAS CHIPPED OR MELTED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8874470 ↗
• MalfunctionNov 20, 2018Break; Break

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE DEVICE SHAFT WAS BURNT DOWN ABOUT 3CM.

  Patient problems: No Patient Involvement

  MAUDE report 8088865 ↗
• MalfunctionJan 18, 2018Break; Device Slipped; Break; Device Slipped

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE TIP OF THE DEVICE WAS BURNED DURING ACTIVATING MONOPOLAR FUNCTION. THE BLACK SHEATH COVER LOOSE FROM THE SHAFT AND THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7203364 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K961771. One submission often covers many models, so check the product and lot details in each record.

• Z-1411-2021 · Mar 5, 2021 · Open, Classified
  Covidien Surgiwand" II Suction and Irrigation Device: Electrosurgical, cutting & coagulation & accessories22 Product Number/CFN: 178083, 178093, 178094