ENDOPATH XCEL B8LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 10705036001256), received between Sep 27, 2022 and Sep 20, 2023 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Crack” (3 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 20, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UNDERNEATH THE LYSIS AREA WERE CHECKED. THERE WAS NO BLEEDING, AND THE TISSUES DID NOT APPEAR TO BE DAMAGED. WHEN THE TROCAR WAS PULLED OUT, IT WAS DISCOVERED THAT THERE WAS A TINY HOLE IN THE MIDDLE OF THE SHAFT OF THE TROCAR (0.5CM IN LENGTH AND 0.5CM FROM THE TIP OF THE TROCAR). THE PATIENT WAS NOT INJURED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17783162 ↗
• MalfunctionJul 12, 2023Crack; Crack

  IT WAS REPORTED THAT DURING AN UNK PROCEDURE, UPON END OF CASE TROCAR CRACKS APPEARED ON SHEATH OF PORT. UNKNOWN IF THE SURGERY WAS DELAYED OR COMPLETED SUCCESSFULLY. NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17310624 ↗
• MalfunctionDec 7, 2022Crack; Crack

  IT WAS REPORTED THAT PRE-OP TO THE LAPAROSCOPIC HYSTERECTOMY PROCEDURE, WHEN THEY REMOVED FROM PACKAGED AND PLACED THE OBTURATOR IN THE CANNULA, THE CANNULA CRACKED IN HALF. ALL PIECES WERE RETRIEVED AND ARE READY TO BE SENT IN FOR ANALYSIS. A LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15933525 ↗
• InjurySep 27, 2022Use of Device Problem; Patient Device Interaction Problem; Use of Device Problem; Patient Device Interaction Problem

  IT WAS REPORTED VIA JOURNAL ARTICLE; TITLE: THE EFFECT OF TRANSVESTIBULAR ENDOSCOPIC SURGERY ON THE COSMETIC OUTCOME AND LONG-TERM PROGNOSIS OF PATIENTS WITH UNILATERAL THYROID CARCINOMA. AUTHORS: HE LIANG, LI LEILEI, WU YALEI, QIU ZHENGLUN, ZHANG YANFANG. CITATION: CHINESE JOURNAL OF CLINICAL PRACTICAL MEDICINE, FEBRUARY 2021, VOL. 12, NO. 1, DOI: 10 3760/CMA J CN115570 ¯ 20200914 01423. THE OBJECTIVE OF THE STUDY WAS TO INVESTIGATE THE EFFECT OF TRANSORAL VESTIBULAR APPROACH ENDOSCOPY ON THE COSMETIC OUTCOME AND LONG-TERM PROGNOSIS OF PATIENTS WITH UNILATERAL PAPILLARY THYROID CARCINOMA. FROM NOVEMBER 2017 TO DECEMBER 2019, 80 PATIENTS WITH UNILATERAL PAPILLARY THYROID CARCINOMA WERE INCLUDED IN THE STUDY. THE PATIENTS WERE RANDOMLY DIVIDED INTO THE TOTAL AREOLA APPROACH GROUP AND THE TRANSORAL VESTIBULAR APPROACH GROUP, WITH 40 PATIENTS IN EACH GROUP. IN THE TOTAL AREOLA APPROACH GROUP, THERE WERE 8 MALES AND 32 FEMALES WITH A MEAN AGE OF 52.23 ± 5.32 YEARS (RANGE 35 TO 67 YEARS). IN THE TRANSORAL VESTIBULAR APPROACH GROUP, THERE WERE 9 MALES AND 31 FEMALES WITH A MEAN AGE OF 52.46 +/-5.58 YEARS (RANGE 33 TO 65 YEARS). IN THE TOTAL AREOLA APPROACH GROUP, THE 10 CM ENDOPATH XCEL

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15495062 ↗