Surgiwand II 178081Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10884523000863), received between Apr 6, 2018 and Apr 27, 2022 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Break” (2 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER PRIOR TO A PROCEDURE, THE SURGIWAND BUTTON WAS LOOSE AND DROPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14220470 ↗
• MalfunctionFeb 21, 2020Break; Suction Problem; Break; Suction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE FIRST DEVICE BROKE SHORTLY AFTER STARTING TO USE IT. THE SECOND ONE'S ISSUE WAS THAT TOTAL SUCTION DID NOT WORK. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9742239 ↗
• MalfunctionApr 6, 2018Break; Break

  ACCORDING TO THE REPORTER, DURING TOTALLY LAPAROSCOPIC DISTAL GASTRECTOMY, THE DEVICE¿S SUCTION BUTTON WAS BROKEN. NEW DEVICE WAS USED TO COMPLETE THE CASE. NO REPORTED PATIENT OUTCOME.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7402638 ↗

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