One-Step™ 00884450012079Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00884450012079), received between Sep 29, 2023 and Oct 2, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2023Fracture; Material Separation; Fracture; Material Separation

  THE ACCOUNT ALLEGES THAT AN ADULT FEMALE PRESENTED TO THE EMERGENCY DEPARTMENT WITH FEVER, CHILLS, AND RIGHT LOWER QUADRANT ABDOMINAL PAIN POST RIGHT FEMORAL AND UMBILICAL HERNIA REPAIR WITH MESH 17 MONTHS AGO. THREE WEEKS PRIOR TO ARRIVAL TO EMERGENCY DEPARTMENT, THE PATIENT EXPERIENCED RECURRENT RIGHT INGUINAL FLUID COLLECTION AND REQUIRED ASPIRATION AND DRAIN IN INTERVENTIONAL RADIOLOGY. THE DRAIN WAS REMOVED 4 DAYS PRIOR TO EMERGENCY DEPARTMENT ARRIVAL. CT IMAGING SHOWED INCREASED SIZE OF FLUID COLLECTION, AS WELL AS RETAINED FOREIGN BODY MEASURING 1.1 CENTIMETERS. THE PATIENT UNDERWENT ROBOT-ASSISTED FOREIGN BODY REMOVAL AND ABCESS DRAINAGE.

  Patient problems: Abdominal Pain; Chills; Fever; Foreign Body In Patient

  MAUDE report 17857653 ↗
• MalfunctionSep 29, 2023

  THIS IS AN ADULT FEMALE WITH HISTORY OF HERNIA REPAIR WHO PRESENTED TO EMERGENCY DEPARTMENT (ED) WITH FEVER, CHILLS, AND ABDOMINAL PAIN. PATIENT IS STATUS POST RIGHT FEMORAL AND UMBILICAL HERNIA REPAIR WITH MESH 17 MONTHS AGO. POST-SURGERY, THE PATIENT EXPERIENCED RECURRENT RIGHT INGUINAL FLUID COLLECTIONS AND HAD AN ASPIRATION AND DRAIN PLACED IN INTERVENTIONAL RADIOLOGY 3 WEEKS BEFORE ARRIVAL TO ED. THE DRAIN WAS REMOVED AFTER 2.5 WEEKS AND SHE DEVELOPED FEVER, CHILLS, AND RIGHT LOWER QUADRANT (RLQ) ABDOMINAL PAIN 4 DAYS POST REMOVAL. COMPUTERIZED TOMOGRAPHY (CT) IMAGING SHOWED INCREASED SIZE OF THE FLUID COLLECTION, AS WELL AS A SMALL RETAINED FOREIGN BODY MEASURING 1.1 CM. ULTRASOUND IMAGING 2 DAYS LATER REVEALED SIMILAR FINDINGS: ¿9 MM ECHOGENIC, TUBULAR STRUCTURE IN THE RIGHT LOWER QUADRANT COLLECTION. THIS COULD REPRESENT A FRAGMENT OF DRAINAGE CATHETER.¿ GENERAL SURGERY CONSULTED TO EVALUATE THE PATIENT. THE PATIENT UNDERWENT ROBOT-ASSISTED FOREIGN BODY REMOVAL AND ABSCESS DRAINAGE.

  Patient problems: Abdominal Pain; Abscess; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Chills; Fever; Foreign Body In Patient

  MAUDE report 17842440 ↗