NA ETH2B5LTRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10888551010795), received between Nov 21, 2018 and Dec 31, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Contamination with Chemical or Other Material” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 31, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC PROCEDURE WITH A ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE AND THE PHYSICIAN NOTED TISSUE DEBRIS INSIDE THE DEVICE. THE DEVICE DID CONTACT THE PATIENT. THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8207018 ↗
• MalfunctionDec 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPY PROCEDURE WITH A ENDOPATH XCEL BLADE-LESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE AND THE PHYSICIAN REPORTED DEBRIS IN OBTURATOR WHILE USING REPROCESSED TROCAR. THE DEVICE DID CONTACT THE PATIENT. HOWEVER, THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8190394 ↗
• MalfunctionNov 21, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC GASTRIC SLEEVE BYPASS PROCEDURE WITH A ENDOPATH XCEL BLADELESS OPTIVIEW TECHNOLOGY W/STABILITY SLEEVE AND FOREIGN MATERIAL WAS PRESENT ON THE OBTURATOR TIP. THE DEVICE DID CONTACT THE PATIENT. HOWEVER, AN ALTERNATIVE DEVICE (RPO ETH2B5LT) WAS USED TO COMPLETE THE PROCEDURE. THE INTENT OF THE PROCEDURE WAS NOT ALTERED AS A RESULT OF THE ISSUE AND THERE WAS NO PATIENT CONSEQUENCE. THIS EVENT HAS BEEN ASSESSED AS REPORTABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8095711 ↗