ENDOPATH BTD05Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10705036011873), received between Apr 13, 2022 and Mar 6, 2025 — classified as 1 injury, 6 malfunctions.

The most frequently reported specific device problem is “Delivered as Unsterile Product” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2025Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN SURGERY, THERE WERE SCRATCHES ON THE HANDLE WHEN CHECKED THE DEVICE BEFORE USE. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21540560 ↗
• MalfunctionDec 4, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF THE PAD BREAKS DOWN. TAMPON UNUSABLE BECAUSE THERE IS A RISK OF LOSING THE PAPER TIP INTRATHORACIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20845972 ↗
• InjuryApr 9, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THIS REPORT IS BEING FILED AFTER THE REVIEW OF A CLINICAL EVALUATION REPORT (CER) FROM A RELATED RESEARCH ACTIVITY DATABASE (DRRA) FOR PATIENTS UNDERGOING UNKNOWN PROCEDURE. EVALUATION OF OUTCOMES OF ENDOPATH ENDOSCOPIC HAND INSTRUMENTS. PRESENCE OF AN ICD-9/10-CM PRIMARY OR SECONDARY DIAGNOSIS CODE FOR ACCIDENTAL PUNCTURE OR LACERATION DURING THE INDEX ADMISSION. ICD-9/10-CM PRIMARY OR SECONDARY DIAGNOSIS CODE.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 19072291 ↗
• MalfunctionDec 28, 2023Device Markings/Labelling Problem; Device Markings/Labelling Problem

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, GOT THE 10 ML ITEM (BCD10) AND THEY WERE SUPPOSED TO GET THE 5ML (BTD05). NO PATIENT HARM/INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18409599 ↗
• MalfunctionMay 24, 2023Delivered as Unsterile Product; Delivered as Unsterile Product

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, A FOREIGN MATTER LIKE A DUST OR INSECT WAS FOUND IN ONE STERILIZED PACKAGE OUT OF ONE BOX. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16993083 ↗
• MalfunctionAug 12, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC CHOLECYSTECTOMY THE CUSTOMER USED AN ENDOPATH 5MM BLUNT TIP DISSECTOR. WHILE REMOVING THE DEVICE, THE FIBER TIP CAME UNDONE AND GOT LODGED IN THE TROCAR. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WERE FRAGMENTS GENERATED AND THE TROCAR HAD TO THE DISASSEMBLED. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15218968 ↗
• MalfunctionApr 13, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ANTERIOR RESECTION, IT WAS FOUND THAT THE COTTON TIP HAD FALLEN OFF WHEN THE DEVICE WAS REMOVED FROM THE PATIENT. THE PROCEDURE WAS INTERRUPTED TO FIND IT. IT WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14106390 ↗