Extra View OMS-XB2Recalls & reported problems

Summary

The FDA's MAUDE database contains 47 adverse event reports that list this exact device (DI 10884521068032), received between Apr 11, 2017 and Jun 2, 2026 — classified as 47 malfunctions.

The most frequently reported specific device problem is “Break” (25 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 47 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 2, 2026Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, INTRA-OPERATIVELY OF A LAPAROSCOPIC HERNIA REPAIR, WHILE IN THE ABDOMEN, THE BALLOON DETACHED FROM THE HANDPIECE AND FELL INTO THE PATIENT¿S CAVITY. THE BALLOON WAS RETRIEVED LAPAROSCOPICALLY AND WAS FOUND TO BE INTACT.

  Patient problems: Insufficient Information

  MAUDE report 25361953 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST AND IT WAS IMPOSSIBLE TO INFLATE. THIS OCCURRED FOUR TIMES, REQUIRING THE USE OF FOUR ADDITIONAL DEVICES BEFORE ONE WORKED ON THE FIFTH ATTEMPT. A LOSS OF SURGICAL TIME WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338016 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST AND IT WAS IMPOSSIBLE TO INFLATE. THIS OCCURRED FOUR TIMES, REQUIRING THE USE OF FOUR ADDITIONAL DEVICES BEFORE ONE WORKED ON THE FIFTH ATTEMPT. A LOSS OF SURGICAL TIME WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25338002 ↗
• MalfunctionMay 29, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST AND IT WAS IMPOSSIBLE TO INFLATE. THIS OCCURRED FOUR TIMES, REQUIRING THE USE OF FOUR ADDITIONAL DEVICES BEFORE ONE WORKED ON THE FIFTH ATTEMPT. A LOSS OF SURGICAL TIME WAS REPORTED. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25337901 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA REPAIR, THE BALLOON PHYSICALLY BROKE. THE DEVICE WAS REPLACED TO COMPLETE THE CASE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838499 ↗
• MalfunctionNov 26, 2025Break; Inflation Problem; Break; Inflation Problem

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, THE BALLOON DID NOT INSUFFLATE DURING THE DISSECTION OF THE SPACE. THE ISSUE WAS RESOLVED BY SWAPPING TO ANOTHER BALLOON TO COMPLETE THE CASE. THE BALLOON WAS INSPECTED, AND IT WAS CONFIRMED THAT THERE WAS A HOLE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23654985 ↗
• MalfunctionJun 12, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL EXTRAPERITONEAL (TEP) HERNIA REPAIR PROCEDURE, THE TROCAR BURST AFTER INSUFFLATION, AND THE BALLOON PHYSICALLY BROKE. THE ISSUE WAS RESOLVED BY REMOVING THE TROCAR SINCE THE ACTUAL PROCESS HAD BEEN COMPLETED. NO INJURY OR COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22195200 ↗
• MalfunctionMay 29, 2025Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA PROCEDURE, ONE BALLOON MADE STRANGE NOISE AND DID NOT FULLY INFLATE. THE SURGEON STILL USED THE TROCAR DESPITE IT NOT BEING FULLY INFLATED. TWO OTHER BALLOONS THAT WERE ALSO USED PHYSICALLY BROKE AND DID NOT INFLATE. THE SURGEON JUST HAD TO USE BLUNT DISSECTION TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105921 ↗
• MalfunctionMay 29, 2025Break; Inflation Problem; Break; Inflation Problem

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) HERNIA PROCEDURE, ONE BALLOON MADE STRANGE NOISE AND DID NOT FULLY INFLATE. THE SURGEON STILL USED THE TROCAR DESPITE IT NOT BEING FULLY INFLATED. TWO OTHER BALLOONS THAT WERE ALSO USED PHYSICALLY BROKE AND DID NOT INFLATE. THE SURGEON JUST HAD TO USE BLUNT DISSECTION TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22105822 ↗
• MalfunctionMay 13, 2025Break; Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC TEP (TOTALLY EXTRAPERITONEAL) INGUINAL PROCEDURE, THE BALLOON PHYSICALLY BROKE WHILE INFLATING THE BALLOON. THE ISSUE WAS RESOLVED BY USING BLUNT DISSECTION TO CREATE SPACE. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22010886 ↗
• MalfunctionApr 22, 2025Break; Break

  IT WAS REPORTED THAT PRIOR TO USE, THERE WAS A HOLE IN THE BALLOON. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21884446 ↗
• MalfunctionJan 23, 2025Break; Gas/Air Leak; Break; Gas/Air Leak

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE BALLOON BROKE AND DEFLATED DURING DISSECTION. NOTHING WAS DONE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21218672 ↗
• MalfunctionDec 27, 2024Break; Gas/Air Leak; Break; Gas/Air Leak

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA PROCEDURE, THE BALLOON WAS BEING USED FOR DISSECTION IN THE PRE-PERITONEAL SPACE WHEN IT PHYSICALLY BROKE AND DEFLATED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT PERMANENT IMPAIRMENT, AND THE EVENT DID NOT LEAD TO OR EXTEND PATIENT HOSPITALIZATION. THERE WAS NO INJURY, TISSUE DAMAGE, OR SIGNIFICANT BLOOD LOSS REPORTED. THE SURGICAL TIME AND INCISION WERE NOT EXTENDED DUE TO THE PRODUCT ISSUE, AND NOTHING WAS NEEDED TO CONTINUE THE PROCEDURE. NO ADDITIONAL OPERATION WAS PLANNED TO CORRECT THE ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21027939 ↗
• MalfunctionDec 6, 2024Gas/Air Leak; Gas/Air Leak

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC HERNIA REPAIR PROCEDURE, THE TROCAR WAS APPLIED TO THE PREPERITONEAL PLANE WHEN THE BALLOON PHYSICALLY BROKE AND DEFLATED. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO RESOLVE THE ISSUE, AND THE CASE WAS COMPLETED WITHOUT EXTENDING SURGICAL TIME OR CAUSING ANY INJURY TO THE PATIENT. THE DEVICE WAS REPLACED BY A NEW PRODUCT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20864291 ↗
• MalfunctionOct 17, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, THE BALLOON PHYSICALLY BROKE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20470816 ↗
• MalfunctionJun 13, 2024Break; Break

  ACCORDING TO THE REPORTER, IN A LAPAROSCOPIC UMBILICAL HERNIA REPAIR, THE BALLOON POPPED. A SMALLER BALLOON WAS USED TO RESOLVE THE ISSUE AND CONTINUE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19530187 ↗
• MalfunctionJun 13, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UMBILICAL HERNIA REPAIR PROCEDURE, THE DISSECTOR BALLOON POPPED. IT WAS NOTED THAT THE BALLOON ONLY HAD 15 PUMPS. A SMALL BALLOON SIZE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19529038 ↗
• MalfunctionMar 22, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, WHEN INFLATING THE BALLOON, THE BALLOON PHYSICALLY BROKE. THE SURGEON REMOVED THE DEVICE AND CONTINUED THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18964074 ↗
• MalfunctionFeb 22, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAP TOTAL EXTRAPERITONEAL HERNIA REPAIR, THREE TROCARS ALL FAILED FOR USE. ONE TROCAR SEAL CAME OFF COMPLETELY WHILE IN USE, TWO TROCARS LEAKING AROUND THE SEAL AND ONE OF THESE TWO FAILED COMPLETELY WHEN ATTEMPTING TO INSERT MESH THROUGH SAME. HAD TO OPEN NEW ONES CONTINUALLY IN ORDER TO COMPLETE SURGERY AND DELAYED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758585 ↗
• MalfunctionFeb 21, 2024Leak/Splash; Adverse Event Without Identified Device or Use Problem; Leak/Splash; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A LAP TOTAL EXTRAPERITONEAL HERNIA REPAIR, THREE TROCARS ALL FAILED FOR USE. ONE TROCAR SEAL CAME OFF COMPLETELY WHILE IN USE, TWO TROCARS LEAKING AROUND THE SEAL AND ONE OF THESE TWO FAILED COMPLETELY WHEN ATTEMPTING TO INSERT MESH THROUGH SAME. HAD TO OPEN NEW ONES CONTINUALLY IN ORDER TO COMPLETE SURGERY AND DELAYED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18755035 ↗
• MalfunctionFeb 21, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAP TOTAL EXTRAPERITONEAL HERNIA REPAIR, THREE TROCARS ALL FAILED FOR USE. ONE TROCAR SEAL CAME OFF COMPLETELY WHILE IN USE, TWO TROCARS LEAKING AROUND THE SEAL AND ONE OF THESE TWO FAILED COMPLETELY WHEN ATTEMPTING TO INSERT MESH THROUGH SAME. HAD TO OPEN NEW ONES CONTINUALLY IN ORDER TO COMPLETE SURGERY AND DELAYED SURGICAL TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754444 ↗
• MalfunctionNov 29, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UROLOGY PROCEDURE, THE BALLOON DISENGAGED FROM THE TROCAR OR SLEEVE AND FELL INTO THE CAVITY OF THE PATIENT. THE BALLOON WAS TAKEN OUT BY USING A LAPAROSCOPIC FORCEPS AND A 12 MILLIMETER TROCAR, AND THE SURGERY WAS CONTINUED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18230955 ↗
• MalfunctionAug 3, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR PROCEDURE, AT THE FINAL STEP OF THE BALLOON DISSECTION PROCESS, WHEN THE SURGEON TRIED PULLING OUT THE BALLOON THROUGH THE TROCAR WHILE IT WAS IN THE PRE-PERITONEAL SPACE OF THE ABDOMEN, THE BALLOON PORTION DETACHED AND FELL INTO THE CAVITY. THE BALLOON WAS RETRIEVED BY USING GRASPERS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17454823 ↗
• MalfunctionMay 11, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, DURING THE INSERTION OF THE FIRST PORT WITH THE BALLOON, THE BALLOON BURST WHILE INFLATING EVEN THOUGH IT WAS NOT FULLY INFLATED. THE DEVICE WAS REMOVED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16916191 ↗
• MalfunctionMar 16, 2023Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC TOTALLY EXTRAPERITONEAL (TEP) INGUINAL HERNIA REPAIR, WHEN THE BALLOON WAS INSUFFLATED FOR DISSECTION, THE BALLOON PHYSICALLY BROKE. A NEW SPACEMAKER WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16553596 ↗