n.a. 26167FNSRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 04048551095362), received between Sep 26, 2017 and Nov 20, 2025 — classified as 6 injuries, 3 malfunctions.

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

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 20, 2025Break; Break

  IT WAS REPORTED THAT A NEEDLE HOLDER BROKE DURING SURGERY. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23606877 ↗
• InjuryMay 24, 2024Detachment of Device or Device Component; Insufficient Device Problem Information; Detachment of Device or Device Component; Insufficient Device Problem Information

  IT WAS REPORTED THAT DURING AN ANTERIOR PROMONTOFIXATION WITH PLACEMENT OF TAPES VIA LAPAROSCOPY, ONE OF THE JAWS OF THE NEEDLE HOLDER BROKE DURING THE INTRODUCTION OF THE INSTRUMENT INTO THE ABDOMEN. AFTER SEARCHING THE ENVIRONMENT AND SURGICAL EXPLORATION, THE BROKEN JAW COULD NOT BE FOUND. PRESENCE IN THE PATIENT'S ABDOMEN OF A 2X8.5MM PIECE OF METAL FOUND DURING AN UNPREPARED ABDOMINAL X-RAY ON (B)(6) 2024. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: INFORM THE PATIENT OF THE RISKS. DUE TO THE FRAGEMENT REMAINED IN SITU A REPORT IS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19392787 ↗
• InjuryMay 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN ANTERIOR PROMONTOFIXATION WITH PLACEMENT OF TAPES VIA LAPAROSCOPY, ONE OF THE JAWS OF THE NEEDLE HOLDER BROKE DURING THE INTRODUCTION OF THE INSTRUMENT INTO THE ABDOMEN. AFTER SEARCHING THE ENVIRONMENT AND SURGICAL EXPLORATION, THE BROKEN JAW COULD NOT BE FOUND. PRESENCE IN THE PATIENT'S ABDOMEN OF A 2X8.5MM PIECE OF METAL FOUND DURING AN UNPREPARED ABDOMINAL X-RAY ON (B)(6) 2024. ACTIONS TAKEN IN THE CARE FACILITY TO MANAGE THE PATIENT: INFORM THE PATIENT OF THE RISKS. DUE TO THE FRAGEMENT REMAINED IN SITU A REPORT IS REQUIRED.

  Patient problems: Foreign Body In Patient

  MAUDE report 19392786 ↗
• InjuryApr 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT HAD A FOLLOW UP CT SCAN RECENTLY AFTER A SURGERY IN MID-(B)(6) 2023, AND A FOREIGN BODY WAS PICKED UP ON THE SCAN. THE PATIENT CAME IN FOR SURGERY ON FRIDAY (B)(6) TO HAVE THE FOREIGN BODY REMOVED WHICH WAS SUCCESSFUL AND IT LOOKS TO BE PART OF A NEEDLE HOLDER. AT THE TIME OF INITIAL SURGERY, THE BROKEN PART WAS NOT NOTICED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE EVENT CAUSED ADDITIONAL SURGICAL INTERVENTION TO REMOVE BROKEN PIECE FROM THE PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 19154498 ↗
• InjuryApr 22, 2024Material Fragmentation; Material Fragmentation

  IT WAS REPORTED THAT PATIENT HAD A FOLLOW UP CT SCAN RECENTLY AFTER A SURGERY IN MID-(B)(6) 2023, AND A FOREIGN BODY WAS PICKED UP ON THE SCAN. THE PATIENT CAME IN FOR SURGERY ON FRIDAY (B)(6) TO HAVE THE FOREIGN BODY REMOVED WHICH WAS SUCCESSFUL AND IT LOOKS TO BE PART OF A NEEDLE HOLDER. AT THE TIME OF INITIAL SURGERY, THE BROKEN PART WAS NOT NOTICED. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. THE EVENT CAUSED ADDITIONAL SURGICAL INTERVENTION TO REMOVE BROKEN PIECE FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 19154497 ↗
• MalfunctionMay 9, 2023Break; Material Fragmentation; Break; Material Fragmentation

  IT WAS REPORTED THAT THERE WAS EVENT WITH A 26167FNS ULTRAMICRO NEEDLE HOLDER. ACCORDING TO THE INFORMATION RECEIVED, PART OF THE NEEDLE HOLDER BROKE OFF INTO THE PATIENT AND NEEDED TO BE RETRIEVED. NO PATIENT HARM NOTED AT TIME OF THIS REPORT.

  Patient problems: Insufficient Information

  MAUDE report 16894483 ↗
• InjuryFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS DISCOVERED ONE OF THE GRIPPING TIPS FROM THE 3MM LAPAROSCOPIC NEEDLE HOLDER WAS MISSING. THE STAFF WAS UNSURE IF IT WAS THERE AT THE BEGINNING OF THE CASE. THE PATIENT HAS SINCE BEEN X-RAYED AND IT APPEARS THE SMALL PART OF THE NEEDLE HOLDER IS STILL INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16380751 ↗
• InjuryFeb 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS DISCOVERED ONE OF THE GRIPPING TIPS FROM THE 3MM LAPAROSCOPIC NEEDLE HOLDER WAS MISSING. THE STAFF WAS UNSURE IF IT WAS THERE AT THE BEGINNING OF THE CASE. THE PATIENT HAS SINCE BEEN X-RAYED AND IT APPEARS THE SMALL PART OF THE NEEDLE HOLDER IS STILL INSIDE THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16380747 ↗
• MalfunctionSep 26, 2017Material Separation; Material Separation

  ALLEGEDLY, DURING AN ESOPHAGEAL REPAIR PROCEDURE, A PIECE OF THE NEEDLE HOLDER BROKE OFF INSIDE THE PATIENT AND WAS RETAINED.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6896192 ↗