Surgineedle 172016Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 20884521080819), received between Aug 14, 2020 and Sep 8, 2022 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 8, 2022Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROSTATECTOMY PROCEDURE, THE DEVICE CAME WITH A DEFECT; THE SEAL WAS DAMAGED. THERE FORE THE CAVITY COULD NOT BE INFLATED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15381129 ↗
• MalfunctionJan 3, 2022Device Damaged Prior to Use; Detachment of Device or Device Component; Device Damaged Prior to Use; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY PROCEDURE, WHILE AT THE ABDOMEN INITIAL STAGE, THE NEEDLE COMES LOOSE INSIDE THE PACKAGING. THE SEAL WAS DISENGAGED WHEN THE PACKAGING WAS OPENED. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13142700 ↗
• MalfunctionOct 29, 2021Detachment of Device or Device Component; Human-Device Interface Problem; Detachment of Device or Device Component; Human-Device Interface Problem

  ACCORDING TO THE REPORTER DURING LAPAROSCOPIC CYST REMOVAL, THE SEAL DISENGAGED. GAS WOULD NOT PASS THROUGH THE NEEDLE AFTER IT WAS PLACED IN THE PATIENTS ABDOMEN. TO FIX THE ISSUE, ANOTHER DEVICE WAS USED IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12721039 ↗
• MalfunctionAug 14, 2020Break; Packaging Problem; Break; Packaging Problem

  ACCORDING TO THE REPORTER, ON A LAPAROSCOPIC SLEEVE GASTRECTOMY, DURING INSUFFLATION, THE NEEDLE WAS FOUND BROKEN AND THE INTERNAL PART OF THE DEVICE HAS FALLEN APART. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10407099 ↗