n.a. 26173KLRecalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 04048551001110), received between Sep 15, 2021 and May 8, 2026 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (7 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 8, 2026Material Fragmentation

  DURING A UTERINE CONTRACTION, A FRAGMENT OF THE NEEDLE HOLDER BROKE OFF. THE X-RAY REVEALED A FOREIGN OBJECT THAT APPEARED TO BE THE BROKEN OFF PART. THE FRAGMENT WAS SUCCESSFULLY REMOVED, AS CONFIRMED BY A FOLLOW-UP X-RAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25122801 ↗
• InjuryFeb 12, 2025Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NEW INFORMATION RECEIVED. ACCORDING TO THE NEW INFORMATION DURING A LAPAROSCOPIC HYSTERECTOMY, THE VAGINAL SEPTUM WAS SUTURED AND A METAL PIECE APPROXIMATELY 1 MM IN SIZE CAME LOOSE FROM THE TIP OF THE INSTRUMENT AND FELL INTO THE PATIENT'S ABDOMINAL CAVITY. THE LOOSE PIECE WAS FOUND AND REMOVED, BUT IT IS NOT CERTAIN WHETHER OTHER PIECES REMAINED IN THE PATIENT. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21369440 ↗
• MalfunctionFeb 5, 2025Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT, TUNGSTEN PLAQUE FOUND DURING A LAPAROSCOPY IN THE PATIENTS ABDOMEN. REMOVED AND SET ASIDE. NO DEATH OR UNANTICIPATED SERIOUS DETERIORATION IN STATE OF HEALTH REPORTED.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 21318173 ↗
• InjuryApr 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NEEDLE HOLDER BROKE IN THE PATIENT'S ABDOMEN. DESPITE X-RAY CHECKS THE SMALL METAL PART COULD NOT BE LOCATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128303 ↗
• InjuryApr 17, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT THE NEEDLE HOLDER BROKE IN THE PATIENT'S ABDOMEN. DESPITE X-RAY CHECKS THE SMALL METAL PART COULD NOT BE LOCATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19128236 ↗
• InjuryOct 26, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY, A SMALL METAL PIECE IS DISLOCATED FROM THE NEEDLE HOLDER. THIS FRAGMENT ENDED UP IN THE PATIENT'S ABDOMEN. THERE IS NO INFORMATION THE FRAGMENT IN QUESTION COULD BE RETRIEVED. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15675196 ↗
• InjuryOct 26, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT DURING SURGERY, A SMALL METAL PIECE IS DISLOCATED FROM THE NEEDLE HOLDER. THIS FRAGMENT ENDED UP IN THE PATIENT'S ABDOMEN. THERE IS NO INFORMATION THE FRAGMENT IN QUESTION COULD BE RETRIEVED. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 15675194 ↗
• InjuryOct 24, 2022Material Separation; Material Separation

  ACCORDING TO THE CUSTOMER REPORT TO THE SWEDISH MEDICAL PRODUCT AGENCY: A SMALL PIECE OF METAL REPEATEDLY DETACHED FROM THE HANDRAIL ON THE NEEDLE DRIVER. THE PIECE OF METAL HAD DETACHED ON 5 OCCASIONS. THE SMALL PIECE OF METAL MAY HAVE ENDED UP IN THE PATIENT'S ABDOMEN. THE SMALL PIECE OF METAL MAY HAVE ENDED UP IN THE PATIENT'S ABDOMEN. A SMALL METAL PART HAS BEEN LOCATED AND REMOVED. IT IS UNKNOWN IF ANOTHER PIECE OF METAL WAS NOT RECOVERED FROM THE PATIENT'S BODY. NO PATIENT HARM HAS BEEN NOTED. ACCORDING TO THE CUSTOMER REPORT TO THE MANUFACTURER: THE CUSTOMER COMPLAINS THAT THE PULL ROD BRAKES FREQUENTLY AND REQUESTS FURTHER ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659024 ↗
• InjuryOct 24, 2022Material Separation; Material Separation

  ACCORDING TO THE CUSTOMER REPORT TO THE SWEDISH MEDICAL PRODUCT AGENCY: A SMALL PIECE OF METAL REPEATEDLY DETACHED FROM THE HANDRAIL ON THE NEEDLE DRIVER. THE PIECE OF METAL HAD DETACHED ON 5 OCCASIONS. THE SMALL PIECE OF METAL MAY HAVE ENDED UP IN THE PATIENT'S ABDOMEN. THE SMALL PIECE OF METAL MAY HAVE ENDED UP IN THE PATIENT'S ABDOMEN. A SMALL METAL PART HAS BEEN LOCATED AND REMOVED. T IS UNKNOWN IF ANOTHER PIECE OF METAL WAS NOT RECOVERED FROM THE PATIENT'S BODY. NO PATIENT HARM HAS BEEN NOTED. THE CUSTOMER COMPLAINS THAT THE PULL ROD BRAKES FREQUENTLY AND REQUESTS FURTHER ANALYSIS. NO PATIENT INVOLVEMENT WAS REPORTED. INTERNAL REFERENCE NUMBER: (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15659012 ↗
• MalfunctionFeb 2, 2022Break; Material Fragmentation; Break; Material Fragmentation

  AS PER A MANUFACTURER INCIDENT REPORT WE RECEIVED FROM THE FACTORY IN (B)(4): PART OF THE INSTRUMENT DROPPED INSIDE PATIENT'S BODY. USER REPORTED THAT THE NEEDLE HOLDER JAW CONNECTOR BROKE DURING SURGERY. AN X RAY WAS DONE BUT THE JAW CONNECTOR COULD NOT BE DETECTED. IT IS SUSPECTED THAT A FOREIGN PART FROM THE INSTRUMENT REMAINED IN THE PATIENT'S BODY. THERE IS NOT YET ENOUGH INFORMATION AVAILABLE TO CLASSIFY THE HEALTH IMPACT OR IF ANY OCCURRED. (MFR'S. INTERNAL COMPLAINT # (B)(4)).

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 13423417 ↗
• InjurySep 15, 2021Physical Resistance/Sticking; Physical Resistance/Sticking

  DURING A MIS MYOMECTOMY, THE JAWS OF THE NEEDLE HOLDER WOULD NOT DISENGAGE FROM THE NEEDLE. THE CASE WAS CONVERTED TO AN "OPEN" PROCEDURE. THE PROCEDURE WAS COMPLETED WITH NO HARM TO PATIENT WITH STANDARD POST - OPERATIVE CARE.

  Patient problems: Insufficient Information

  MAUDE report 12475994 ↗