ENDOPATH BCD10Recalls & reported problems

Summary

The FDA's MAUDE database contains 30 adverse event reports that list this exact device (DI 10705036011866), received between Jul 6, 2018 and Jul 3, 2025 — classified as 30 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (10 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 25 most recent of 30 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISSECTOR COMPLETELY DISINTEGRATED. ACTION TAKEN IMMEDIATELY: DISSECTORS CHANGE PATIENT CONSEQUENCES: NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394333 ↗
• MalfunctionJul 3, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE THE DISSECTOR COMPLETELY DISINTEGRATED. ACTION TAKEN IMMEDIATELY: DISSECTORS CHANGE PATIENT CONSEQUENCES: NONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22394331 ↗
• MalfunctionDec 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COTTON TIP GOT LOOSE DURING 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 11009521 ↗
• MalfunctionDec 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COTTON TIP GOT LOOSE DURING 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 11009515 ↗
• MalfunctionDec 15, 2020Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COTTON TIP GOT LOOSE DURING 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 11009500 ↗
• MalfunctionJul 29, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THORACIC SURGERY, THE COTTON TIP FELL OFF RIGHT AFTER THE DEVICE WAS USED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10339162 ↗
• MalfunctionJun 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE COTTON TIP FELL OFF DURING USE. THE FALLEN PIECE WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137797 ↗
• MalfunctionJun 10, 2020Material Separation; Material Separation

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HYSTERECTOMY, THE COTTON TIP FELL OFF DURING USE. THE FALLEN PIECE WAS RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10137724 ↗
• MalfunctionDec 19, 2019Device Fell

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE TIP OF CHERRY DISSECTOR FELL OFF. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9492811 ↗
• MalfunctionDec 10, 2019Device Fell

  IT WAS REPORTED BY THE SALES REP THAT DURING A LAPAROSCOPIC PNEUMONECTOMY, A COTTON TIP FELL OFF DURING USE. THE DEVICE WAS USED ON THE LUNG. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9447059 ↗
• MalfunctionSep 26, 2019Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, PRODUCT HAD SPLIT INTO PIECES. ALL PIECES OF PRODUCT HAVE BEEN REMOVED FROM PATIENT BODY. TO COMPLETE PROCEDURE, PHYSICIAN USED ANOTHER PRODUCT OF THE SAME TYPE. PATIENT CONSEQUENCE WAS NOT REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9125529 ↗
• MalfunctionAug 13, 2019Device Fell

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC ESOPHAGECTOMY, THE COTTON TIP FELL OFF WHEN THE DEVICE WAS INSERTED INTO THE TROCAR. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8888549 ↗
• MalfunctionJul 22, 2019Detachment of Device or Device Component; Device Fell

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE COTTON TIP GOT DETACHED FROM THE SHAFT AND FELL IN THE PATIENT¿S THORAX. THE COTTON TIP HAS BEEN RECOVERED. EXTENDED PROCEDURE TIME.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8811805 ↗
• MalfunctionJun 4, 2019Device Fell

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PNEUMONECTOMY, THE COTTON TIP FELL INTO THE PATIENT EASILY. THE DEVICE WAS USED ON THE LUNG. THE FALLEN TIP WAS RETRIEVED, AND NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8667647 ↗
• MalfunctionMay 30, 2019Unraveled Material; Device Fell

  IT WAS REPORTED THAT DURING A LAP CHOLECYSTECTOMY, THE END OF THE BLUNT DISSECTOR UNRAVELED AND FELL OFF FROM THE END. IT WAS RETRIEVED. CASE COMPLETED WITH ANOTHER DEVICE OF THE SAME PRODUCT CODE. THERE WERE NO PATIENT CONSEQUENCES REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8655828 ↗
• MalfunctionMay 1, 2019Component Missing; Detachment of Device or Device Component

  DURING CHOLECYSTECTOMY PROCEDURE, BLUNT DISSECTORS WERE USED. THE COTTON BLUNT TIP OF ONE OF THE DISSECTORS CAME OFF AND COULD NOT BE FOUND WITHIN THE ABDOMEN OF THE PATIENT. SURGEON DID A RISK ASSESSMENT AND DECIDED IT WOULD BE BETTER TO CLOSE PATIENT INSTEAD OF CONVERTING TO OPEN SURGERY TO SEARCH FOR THE LITTLE COTTON BLUNT TIP. SURGEON EXPRESSED THAT THE MOST LIKELY SCENARIO IS THAT THE PATIENT WILL BE FINE AND ONLY DEVELOP A LITTLE ¿SCAR¿ OR HARDENING OF THE SURROUNDING TISSUE WHERE THE BLUNT TIP ENDED UP, BUT THEY WILL OF COURSE FOLLOW ANY POST-OPERATIVE EVENTS.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8569524 ↗
• MalfunctionFeb 26, 2019Component Missing; Dull, Blunt

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, UPON REMOVING THE ENDOSCOPIC BLUNT CHERRY DISSECTOR FROM THE CHEST, THE CHERRY AT THE END OF THE STICK WAS MISSING. IT WAS FOUND INSIDE THE WOUND AND REMOVED BY THE SURGEON. IT TOOK SEVERAL MINUTES OF SEARCHING TO FIND IT. NO PACKAGING WAS KEPT, SO CANNOT IDENTIFY LOT NUMBER. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8371526 ↗
• MalfunctionDec 12, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PNEUMONECTOMY, THE COTTON TIP FELL OFF INTO THE PATIENT WHEN THE DEVICE USED ON THE TARGET TISSUE OF THE LUNG. THE FALLEN TIP WAS RETRIEVED, AND NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8156935 ↗
• MalfunctionDec 3, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LEFT PNEUMONECTOMY, THE COTTON TIP FELL OFF INTO THE THORACIC CAVITY DURING USE. IT WAS USED FOR EXCLUSION OF THE LUNG. THE SURGEON COMMENTED THAT NO EXTRA FORCE WAS APPLIED. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8123963 ↗
• MalfunctionNov 30, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC LEFT PNEUMONECTOMY, THE COTTON TIP FELL OFF INTO THE THORACIC CAVITY DURING USE. IT WAS USED FOR EXCLUSION OF THE LUNG. THE SURGEON COMMENTED THAT NO EXTRA FORCE WAS APPLIED. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8120322 ↗
• MalfunctionNov 29, 2018Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE COTTON TIP CAME OFF ABOUT AN HOUR AFTER THE PROCEDURE STARTED. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116090 ↗
• MalfunctionNov 29, 2018Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, IT WAS FOUND THAT THE COTTON TIP CAME OFF ABOUT AN HOUR AFTER THE PROCEDURE STARTED. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8116070 ↗
• MalfunctionOct 11, 2018Break

  IT WAS REPORTED THAT DURING A UROLOGY PROCEDURE, AT THE OR THE TIP BROKE OFF IN THE BELLY. THE PROCEDURE WAS DELAYED BY 10 MINUTES. A NEW PRODUCT WAS OPENED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7955845 ↗
• MalfunctionSep 19, 2018Device Fell

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE COTTON TIP WAS FELL OFF WHEN THE DEVICE WAS BEING REMOVED FROM THE PATIENT VIA A TROCAR. THE FALLEN TIP WAS RETRIEVED WITH A FORCEPS AND NO PIECES WERE LEFT INSIDE THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7891674 ↗
• MalfunctionAug 15, 2018Component Missing

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PNEUMONECTOMY, DEVICE HAD NO TIP. THERE WERE NO PATIENT CONSEQUENCES TO THE PATIENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7785801 ↗