Surgineedle 172015Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10884521080805), received between Jun 20, 2018 and Jan 5, 2026 — classified as 1 injury, 11 malfunctions.

The most frequently reported specific device problem is “Break” (4 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 16, 2026.

Most reported problems

Recent adverse event reports

The 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 5, 2026Difficult to Insert; Dull, Blunt

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC GYNECOLOGICAL PROCEDURE, AT THE STEP OF INSERTING THE PRODUCT, THE NEEDLE WAS FELT TO BE DULL AND WAS DIFFICULT TO PASS THROUGH THE SKIN. ANOTHER DEVICE WAS OPENED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23967698 ↗
• MalfunctionJun 3, 2025Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY, AT THE INSUFFLATION STEP, THE DEVICE POINT WAS TOO BLUNT TO INSERT INTO THE PATIENT, REQUIRING SIGNIFICANT PRESSURE FROM THE PHYSICIAN. TO RESOLVE THE SITUATION, ANOTHER DEVICE OF THE SAME TYPE WAS OPENED TO COMPLETE THE PROCEDURE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22135347 ↗
• MalfunctionJun 28, 2024Difficult to Insert; Difficult to Insert

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC PROSTATE CANCER PROCEDURE, WHEN THE DEVICE WAS USED TO PUNCTURE INTO THE ABDOMINAL WALL, IT COULD NOT PUNCTURE AND SALINE COULD DID NOT PASS THROUGH. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19632807 ↗
• MalfunctionJun 17, 2024Difficult to Insert; Dull, Blunt; Difficult to Insert; Dull, Blunt

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC ROBOTIC CHOLECYSTECTOMY, DURING ABDOMINAL INSUFFLATION AT THE INITIAL ENTRY, THE INSUFFLATION NEEDLE WAS NOT AS SENSITIVE. THE DEVICE DID NOT CLICK WITH EACH LAYER OF FASCIA AND WAS DULL, REQUIRING MORE FORCEFUL PRESSURE WHEN INSERTING INTO THE ABDOMEN TO RESOLVE THE ISSUE TO CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19553639 ↗
• MalfunctionApr 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, AT THE TIME OF INSERTION, THE TOP OF THE ACCESS NEEDLE BROKE OFF. THE DEVICE WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19101579 ↗
• MalfunctionFeb 19, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN CONNECTING THE NEEDLE AT THE TIME OF INSUFFLATION, THE SURGEON NOTICED AND REPORTED THAT THE PNEUMOPERITONEUM NEEDLE WAS BROKEN AND THAT THE DEVICE COULD NOT ESTABLISH PNEUMOPERITONEUM. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18736063 ↗
• MalfunctionMay 17, 2022Break; Break

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE TIP OF THE SURGICAL NEEDLE BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14414411 ↗
• InjuryMar 29, 2022No Device Output; Retraction Problem; No Device Output; Retraction Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE BEGINNING, THE SAFETY DEVICE DID NOT WORK WHEN THE DEVICE WAS INSERTED; THE NEEDLE DID NOT RETRACT AND WAS EXPOSED INSIDE THE ABDOMINAL CAVITY, DAMAGING THE PATIENT'S LIVER. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Unspecified Tissue Injury

  MAUDE report 13939808 ↗
• MalfunctionAug 10, 2021Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, THERE WAS A BREAK IN THE PLASTIC PART OF THE NEEDLE, WHICH IS ATTACHED TO THE GAS SYSTEM. IT COULD NOT HAVE BROKEN BECAUSE IT IS USED TO USE.

  Patient problems: Insufficient Information

  MAUDE report 12304889 ↗
• MalfunctionMar 25, 2019Break; Break

  ACCORDING TO THE REPORTER, DURING A ROBOTIC UROLOGY PROCEDURE, THE NEEDLE WAS BEING INSERTED INTO THE PATIENT WHEN THE NEEDLE BROKE IN HALF. A DELAY OF FEW MINUTES OCCURRED DUE TO NEEDING TO FIND A NEW NEEDLE TO REPLACE THE BROKEN NEEDLE. THE PROCEDURE CONTINUED AS PLANNED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8450119 ↗
• MalfunctionFeb 28, 2019Difficult or Delayed Positioning; Difficult or Delayed Positioning

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, AT THE BEGINNING OF SURGERY FOR PNEUMOPERITONEUM FORMATION, THE DEVICE WAS NOT ABLE TO PIERCE THE TISSUE. THE PRODUCT HAS BEEN EXCHANGE FOR OTHER DEVICE OF THE SAME CODE TO COMPLETE THE PROCEDURE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8377475 ↗
• MalfunctionJun 20, 2018Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE VALVE OF THE DEVICE DISLODGED AND FELL INSIDE THE PATIENT¿S CAVITY. IT WAS LOCATED AND REMOVED AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7620528 ↗