n.a. 26173KPFRecalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 04048551098219), received between Apr 6, 2022 and May 19, 2026 — classified as 2 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 19, 2026Break

  IT WAS REPORTED THAT "THE JAW MECHANISM IS NOT WORKING" AND DURING INITIAL PRODUCT EVALUATION IT WAS FOUND THAT THE JAW-PART IS BROKEN. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25223003 ↗
• MalfunctionOct 25, 2023Defective Component; Defective Component

  IT WAS REPORTED THAT THE NEEDLE HOLDER 26173KPF BROKE IN THE PROCEDURE. NO FURTHER INFORMATION WAS PROVIDED ABOUT THE PROCEDURE, BUT IT WAS STATED THAT THE PATIENT WAS UNHARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18004656 ↗
• InjuryAug 18, 2023Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PART OF THE JAW WAS MISSING DURING THE SURGERY. THE FRAGMENT WAS PROBABLY LEFT IN THE PATIENT'S BODY. ADDITIONAL SURGERY IS REQUIRED TO REMOVE PART OF THE NEEDLE HOLDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17573199 ↗
• InjuryAug 18, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PART OF THE JAW WAS MISSING DURING THE SURGERY. THE FRAGMENT WAS PROBABLY LEFT IN THE PATIENT'S BODY. ADDITIONAL SURGERY IS REQUIRED TO REMOVE PART OF THE NEEDLE HOLDER.

  Patient problems: Foreign Body In Patient

  MAUDE report 17573198 ↗
• MalfunctionApr 6, 2022Material Fragmentation; Material Fragmentation

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(6): THE PATIENT UNDERWENT A PELVISCOPY DURING WHICH THE INSTRUMENT WAS USED. AFTER COMPLETION OF THE OPERATION, IT WAS DISCOVERED THAT A HARD METAL INSERT OF THE NEEDLE HOLDER WAS MISSING. THE PATIENT THEN UNDERWENT AN X-RAY EXAMINATION, WHEREUPON A FRAGMENT COULD BE LOCATED. ANOTHER LAPAROSCOPIC SURGERY WAS PERFORMED TO RETRIEVE THE FRAGMENT. HOWEVER, DUE TO THE UNFAVORABLE POSITION OF THE FRAGMENT IN THE ABDOMINAL CAVITY, IT COULD NOT BE RECOVERED AND REMAINED IN THE PATIENT'S BODY. (MFR'S. INTERNAL COMPLAINT (B)(4).)

  Patient problems: Foreign Body In Patient

  MAUDE report 14021728 ↗