Surgiwand II 178094Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884523000917), received between Sep 22, 2017 and Oct 25, 2021 — classified as 10 malfunctions.

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

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Mar 5, 2021Class IIOpen, 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 · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 25, 2021Melted; Melted

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC PROCEDURE, THE DISTAL TIP OF THE BLACK SHEATH MELTED WHILE CONTROLLING A BLEEDER.

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

  MAUDE report 12689450 ↗
• MalfunctionAug 11, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A GYNECOLOGICAL PROCEDURE, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED, IT WAS REPORTED THAT THE AREA 2.5 CM TO 3 CM FROM THE TIP GOT BENT. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE AND COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12308017 ↗
• MalfunctionAug 11, 2021Melted; Melted

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SHEATH APPEARED TO BE MELTED AT THE TIP. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12307737 ↗
• MalfunctionJan 12, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GYNECOLOGY, THE DEVICE'S CLAW ON THE CLEANING SIDE OF THE SUCTION/CLEANING TRUMPET VALVE BUTTON GOT DAMAGED AND CAME OFF. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11155093 ↗
• MalfunctionDec 22, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT SEPARATION/DISSECTION OF THE UTERUS/APPENDAGE DURING A LAPAROSCOPIC GYNECOLOGICAL SURGERY, THE TIP OF THE ELECTRODE BROKE OFF INTO THE PATIENT'S CAVITY AND WAS RETRIEVED BY FORCEPS. A NEW PRODUCT WAS USED TO RESOLVE THE ISSUE. NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11055579 ↗
• MalfunctionNov 14, 2020Mechanical Problem; Melted; Mechanical Problem; Melted

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE SURGEON REMOVED SUCTION THE IRRIGATOR SYSTEM TO CLEAN THE SPATULA TIP. THE DOCTOR NOTICED THAT SPATULA TIP WAS PROTRUDING OUT OF THE LUMEN WHEN IT USUALLY FULLY RETRACTS UPON FURTHER INVESTIGATION THE LUMEN OF THE SUCTION/IRRIGATOR, IT WAS FOUND TO BE MELTED OFF AND IN THE LAPAROSCOPIC PAD THAT THE USER HAD CLEANED WITH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10841329 ↗
• MalfunctionJul 13, 2018Electrical /Electronic Property Problem; Flare or Flash; Flare or Flash

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THE CURRENT REACHED NOT ONLY THE TIP OF THE DEVICE BUT ALSO PROXIMAL SIDE (HAND SIDE) OF THE DEVICE. IT INFLUENCED MORE TISSUE THAN USUAL. THE INCIDENT WAS REPORTED THAT IT MAY CAUSE BURN. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY.

  Patient problems: Burn(s); No Known Impact Or Consequence To Patient

  MAUDE report 7686342 ↗
• MalfunctionDec 18, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC LOW ANTERIOR RESECTION PROCEDURE, WHILE CLEANING THE DEVICE, SHAFT CAME OFF. THE EVENT OCCURRED DURING THE PROCEDURE BUT THE PRODUCT WAS NOT USED FOR PATIENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7126965 ↗
• MalfunctionDec 5, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLECTOMY PROCEDURE, APPROXIMATELY AN HOUR AFTER STARTING TO USE THE DEVICE AS AN ELECTRIC SCALPEL, SURGEON NOTED THE ELECTRODE WAS UNSTABLE. DURING USE, HE/SHE CHECKED THE DEVICE AFTER REMOVING IT FROM THE PATIENT, AND THE ELECTRODE BROKE OFF. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE SURGICAL TIME WAS EXTENDED BY LESS THAN 30 MIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7085824 ↗
• MalfunctionSep 22, 2017Break; Melted; Break; Melted

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RIGHT HEMICOLECTOMY PROCEDURE, APPROXIMATELY AN HOUR AFTER THE START OF SURGERY, THE TIP OF THE BLACK SHAFT BROKE. THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. DUE TO THE BENDING OF THE ELECTRODE, IT SEEMED TO BE BURNED WHERE IT MADE CONTACT WITH THE SHAFT DURING STORAGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THE STATUS OF THE PATIENT IS ALIVE WITH NO INJURY. .

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6887851 ↗