n.a. 26173KAFRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 04048551098097), received between Jun 22, 2018 and Sep 22, 2026 — classified as 3 injuries, 11 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Break

  According to the received information, during a procedure, the joint at the tip of a Macro Needle Holder broke while using in patient body, as reported by user. An X-ray scan was done and found no foreign objects, user did not feedback if any replacement was used. The clamping jaw is now loose as a result. No negative impact in state of health reported. The reported incident involved a device malfunction during use, which prompted postoperative radiographic examination to exclude the presence of retained device fragments. The imaging confirmed that no foreign body remained in the patient, and no injury, deterioration in health, or other clinically harmful outcome was reported.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50850352 ↗
• MalfunctionSep 16, 2026Break

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794588 ↗
• MalfunctionAug 12, 2026Difficult to Open or Close

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50225683 ↗
• MalfunctionJun 23, 2026Break

  THE FOLLOWING WAS REPORTED: UNIT CLAMPING JAW MOVING JOINT BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: Insufficient Information

  MAUDE report 25601714 ↗
• MalfunctionJun 16, 2026Break

  THE FOLLOWING WAS REPORTED: "DURING A ROUTINE CHECK - BROKEN RIVET". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25527178 ↗
• MalfunctionApr 16, 2026Break

  IT WAS REPORTED THAT WHEN THE DOCTOR TRIED TO GRAB THE NEEDLE, SYSTEM THAT OPERATE THE JAWS BROKE. THERE WAS A DELAY OF 10 MINUTES. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24905357 ↗
• MalfunctionApr 16, 2026Break

  THE EVENT OCCURRED IN ROMANIA. IT WAS REPORTED THAT "WHEN THE DOCTOR TRIED TO GRAB THE NEEDLE, SYSTEM THAT OPERATE THE JAWS BROKE. THERE WAS A DELAY OF 10 MINUTES". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24902123 ↗
• MalfunctionApr 2, 2026Break

  "IT WAS REPORTED THAT "JAWS BROKEN". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769257 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT "JAWS BROKEN". NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24769180 ↗
• InjuryFeb 27, 2026Break

  IT WAS REPORTED THAT MACRO NEEDLE HOLDER, 5 MM, 26173KAF NAMELY SOMETHING AROUND THE BRANCHES FELL APART DURING THE PROCEDURE AND SCATTERED IN THE OPERATING FIELD - ALL THE REMAINS OF THE INSTRUMENT WERE PULLED OUT FROM THE PATIENT. X-RAYS WERE USED TO CHECK THAT EVERYTHING HAD BEEN REMOVED FROM THE PATIENT. THERE WAS A 30 MINUTES PROLONGATION OF SURGERY. NO INFORMATION ABOUT PATIENT INJURY REPORTED. DUE TO X-RAYS BEING TAKEN, A REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475835 ↗
• InjuryFeb 27, 2026Break

  IT WAS REPORTED THAT MACRO NEEDLE HOLDER, 5 MM, 26173KAF NAMELY SOMETHING AROUND THE BRANCHES FELL APART DURING THE PROCEDURE AND SCATTERED IN THE OPERATING FIELD - ALL THE REMAINS OF THE INSTRUMENT WERE PULLED OUT FROM THE PATIENT. X-RAYS WERE USED TO CHECK THAT EVERYTHING HAD BEEN REMOVED FROM THE PATIENT. THERE WAS A 30 MINUTES PROLONGATION OF SURGERY. NO INFORMATION ABOUT PATIENT INJURY REPORTED. DUE TO X-RAYS BEING TAKEN, A REPORT IS REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24475768 ↗
• MalfunctionJan 8, 2026Detachment of Device or Device Component

  THE EVENT OCCURRED IN CANADA. ACCORDING TO THE INFORMATION RECEIVED, NEEDLE HOLDER SNAPPED AFTER 1ST USE. NO INJURY TO PATIENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24003328 ↗
• InjuryNov 6, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025 THAT THAT X-RAYS WERE TAKEN TO SEARCH BROKEN OFF FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23490689 ↗
• MalfunctionJun 22, 2018Material Separation; Material Separation

  ALLEGEDLY, THE DAY AFTER A LAPAROSCOPIC HELLER MYOTOMY PROCEDURE, A FOLLOW-UP X-RAY WAS PERFORMED ON THE PATIENT, WHICH SHOWED A PIECE OF THE NEEDLE HOLDER USED IN THE PROCEDURE WAS INSIDE THE PATIENT'S UPPER ABDOMEN. THE DOCTOR FELT IT WAS RELATIVELY SMALL AND DECIDED NOT TO SCHEDULE ANOTHER SURGERY TO RETRIEVE IT AT THIS TIME.

  Patient problems: Foreign Body In Patient

  MAUDE report 7631902 ↗