Kendall 31479549Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10192253040500), received between Apr 10, 2023 and Apr 21, 2023 — classified as 1 injury, 1 malfunction.

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

• InjuryApr 21, 2023Use of Device Problem; Use of Device Problem

  THE CUSTOMER REPORTED THAT A PATIENT WAS ADMITTED FOR ELECTIVE INDUCTION DUE TO COCCYX PAIN. ONCE THE EPIDURAL WAS PLACED, THE PROVIDER HAD DIFFICULTY PLACING THE FETAL SCALP ELECTRODE (FSE) DUE TO CONCERNS FOR THE FETAL POSITION. AN ULTRASOUND WAS USED REVEALING VERTEX PRESENTATION. IT WAS THEN RECOGNIZED THAT THE BABY WAS HIGH AND IN A BREECH POSITION AND MECONIUM WAS NOTED. THE CUSTOMER HAD MONITORS REMOVED TO GO TO OR FOR A STAT C-SECTION DUE TO BABY'S PRESENTATION. THE FSE WAS NOT TRACING AND WAS CUT BEFORE THE C-SECTION AND PART OF THE FSE WAS NOT REMOVED DUE TO THE RUSH TO THE OR. DUE TO THE FACT THAT THE C-SECTION WAS COMPLETED IN A VERY QUICK MANNER, THERE WERE NO COUNTS DONE PRIOR TO THE PROCEDURE. A POST PROCEDURE XRAY WAS OBTAINED AND THE FINDINGS PER THE RADIOLOGIST WERE "CURVILINEAR FOREIGN BODY WITH A LENGTH/BPD APPEARANCE IN THE MIDLINE LOWER PELVIS AND TO THE RIGHT OF MIDLINE IN LOWER PELVIS". THE RADIOLOGIST WAS NOT AWARE OF WHAT THEY WERE SUPPOSED TO BE LOOKING FOR AND THE IMAGE WAS NOT AVAILABLE FOR THE OB PROVIDERS TO VIEW PRIOR TO THE XRAY TECH LEAVING THE OR. THE RADIOLOGIST CALLED THE OR WITH RESULTS OF A NOT OBVIOUS SPONGE OR INSTRUMENTS IN THE ABDOMEN. HE

  Patient problems: Foreign Body In Patient

  MAUDE report 16788167 ↗
• MalfunctionApr 10, 2023Detachment of Device or Device Component

  CUSTOMER ADMITTED FOR ELECTIVE INDUCTION DUE TO COCCYX PAIN. ONCE EPIDURAL WAS PLACED AND PROVIDER HAD DIFFICULTY PLACING FETAL SCALP ELECTRODE (FSE) DUE TO CONCERN FOR THE FETAL POSITION. ULTRASOUND WAS USED REVEALING VERTEX PRESENTATION. IT WAS THEN RECOGNIZED THAT THE BABY WAS HIGH AND IN A BREECH POSITION AND MECONIUM WAS NOTED. CUSTOMER HAD MONITORS REMOVED TO GO TO OR FOR A STAT C-SECTION DUE TO BABY'S PRESENTATION. THE FSE WAS NOT TRACING AND WAS CUT BEFORE THE C-SECTION AND PART OF IT NOT REMOVED DUE TO THE RUSH TO THE OR. POST PROCEDURE XRAY OBTAINED AND FINDINGS PER RADIOLOGIST WERE "CURVILINEAR FOREIGN BODY WITH A LENGTH/BPD APPEARANCE IN THE MIDLINE LOWER PELVIS AND TO THE RIGHT OF MIDLINE IN LOWER PELVIS". RADIOLOGIST WAS NOT AWARE OF WHAT THEY WERE SUPPOSED TO BE LOOKING FOR AND THE IMAGE WAS NOT AVAILABLE FOR THE OB PROVIDERS TO VIEW PRIOR TO THE XRAY TECH LEAVING THE OR. DUE TO THE FACT THE C-SECTION WAS COMPLETED IN A VERY QUICK MANNER, THERE WERE NO COUNTS DONE PRIOR TO THE PROCEDURE. THE RADIOLOGIST DID CALL THE OR WITH RESULTS OF A NOT OBVIOUS SPONGE OR INSTRUMENTS IN THE ABDOMEN. HE DID NOTE A SPIRAL LIKE DEVICE RUNNING ACROSS THE PATIENT WHICH WAS IDENTIFIED A

  Patient problems: Foreign Body In Patient

  MAUDE report 16706726 ↗