Surgiwand II 178083Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884523000887), received between Nov 30, 2017 and Mar 29, 2021 — classified as 1 injury, 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC CHOLECYSTECTOMY, A WHITE FRAGMENT FELL INTO THE PATIENT CAVITY WHILE USING THE DEVICE. THE COMPONENT WAS TAKEN OUT BY SUCTIONING.

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

  MAUDE report 11582410 ↗
• MalfunctionNov 13, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRE-OPERATIVELY, THE SUCTION BUTTON FELL OFF FROM THE INSTRUMENT WHEN OPENING OF PACKAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Patient Involvement

  MAUDE report 10836161 ↗
• MalfunctionJul 23, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, IN THE MIDDLE OF THE PROCEDURE, A PIECE OF PLASTIC FELL OFF INTO THE PATIENT'S CAVITY WHEN DELIVERING WATER. THE PLASTIC PIECE WAS RETRIEVED AND THE PRODUCT WAS CHANGED TO A NEW ONE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10315901 ↗
• MalfunctionMar 8, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, WHILE BEGINNING TO SUCK THE BLOOD DURING A LAPAROSCOPIC VATS WEDGE RESECTION, THERE WAS LEAK FROM BALLOON THEN AIR LEAK. THEY CHANGED A NEW ONE ON TABLE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7324508 ↗
• InjuryNov 30, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY PROCEDURE, THE DISTAL TIP OF THE BLACK SHEATH WAS DAMAGED. THERE WAS TISSUE DAMAGE - TEMPORARY INJURY OF SLIGHT BURN ON THE UTERUS. THE DEVICE WAS NOT USED TO RESOLVE THE CASE. THE PATIENT WAS ALIVE WITH INJURY.

  Patient problems: Burn(s); Tissue Damage

  MAUDE report 7071894 ↗