SurgyNeedle 780-412Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00810014635118), received between Sep 1, 2024 and Sep 1, 2024 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 18, 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.

• MalfunctionSep 1, 2024Fracture; Fracture

  THE CUSTOMER EMAILED A COMPLAINT THAT THE SURGYNEEDLE PRODUCT (ITEM 780-412) WAS LEAKING DURING A PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115605 ↗
• MalfunctionSep 1, 2024Fracture; Fracture

  THE SURGERY BEGAN AS PLANNED AND THE LEFT AND RIGHT TUBE SEGMENTS WERE TAKEN OUT FOR PATHOLOGY. THE SURGEON AFTER PREFORMING THIS STEP IN SURGERY USES AN INJECTION NEEDLE THAT SLIDES THROUGH THE TROCAR SITE AND INJECTS LOCAL AROUND THE END OF THE TUBE SEGMENTS TO AID IN PAIN CONTROL. DURING THIS STEP, THE INJECTION NEEDLE WAS INSERTED, THE NEEDLE AND PART OF THE PLASTIC BROKE OFF FROM THE INJECTION NEEDLE. AT THIS TIME, SURGEON ORDERED AN X-RAY TO BE TAKEN AS WELL AS SUCTION TO BE SET UP TO RETRIEVE THE BROKEN PIECE OF PLASTIC AND NEEDLE. WAITING ON RADIOLOGY TO COME. THE SURGEON EXPLORED THE PERITONEAL CAVITY TO SEARCH FOR THE NEEDLE AND MISSING PLASTIC. THE NEEDLE WAS FOUND AND PULLED OUT THROUGH THE TROCAR SITE. A FEW X-RAYS WERE THEN TAKEN TO SEE IF THE PLASTIC PIECE WOULD SHOW UP IN THE BODY. AFTER THIS DOCTOR SEARCHED FOR OVER 35 MINUTES FOR THE MISSING PIECE. HE BELIEVED THAT IT WAS STILL IN THE BODY AND HAD EXHAUSTED ALL OPTIONS TO RETRIEVE THE BROKEN PIECE OF PLASTIC WITH NO SUCCESS. HE CLOSED THE SITES TO THE ABDOMEN AND ENDED THE PROCEDURE. SUPPORTING HEALTHCARE STAFF RECOVERED THE PATIENT IN THE POST ANESTHESIA CARE UNIT AND DOCTOR CHECKED IN ON THE PATIENT AND THEIR FA

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20115604 ↗