LAPAROVUE LAPVUE10Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 20845854061746), received between Nov 15, 2021 and Apr 27, 2026 — classified as 10 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (5 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 27, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THELAPVUE10, LAPAROVUE VISIBILITY SYSTEM LAPAROSCOPIC SOLUTIONS DEVICE WAS USED IN A LAP CHOLE PROCEDURE ON (B)(6) 2026, AND ¿PLASTIC CAME OFF AND WENT INTO PATIENT. PLASTIC WAS RETRIEVED¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25003479 ↗
• MalfunctionApr 27, 2026Material Fragmentation

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE LAPVUE10, LAPAROVUE VISIBILITY SYSTEM LAPAROSCOPIC SOLUTIONS DEVICE WAS USED IN A LAP CHOLE PROCEDURE ON (B)(6) 2026, AND ¿PLASTIC PIECE CAME OFF INTO PATIENT. PLASTIC PIECE WAS RETRIEVED¿. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25003173 ↗
• MalfunctionApr 22, 2026Material Fragmentation

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE LAPVUE10, WAS BEING USED DURING A LAP CHOLE ON (B)(6) 2026 AND THE ¿PLASTIC PIECE CAME OFF FROM PRODUCT DURING USE.¿ PER FURTHER ASSESSMENT IT WAS REPORTED THAT THE PLASTIC PIECE FELL INTO THE SURGICAL SITE AND WAS RETRIEVED.¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT OR USER. THE PROCEDURE WAS COMPLETED WITHOUT THE USE OF AN ALTERNATE DEVICE. THIS REPORT IS BEING RAISED DUE TO THE REPORTED MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24957443 ↗
• MalfunctionJun 16, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT ON 22MAY25, THE LAPVUE10, LAPAROVUE VISIBILITY SYSTEM LAPAROSCOPIC SOLUTIONS DEVICE WAS USED IN A ROBOT ASSISTED LAPAROSCOPIC SURGERY WITH AIRSEAL PORTS AND DAVINCI PORTS AND ¿THE TIP OF THE CLEANING SWAB CAME OFF COMPLETELY AND REMAINED IN THE PORT DURING NORMAL USE TO CLEAN THE PORT. THIS HAS POSED A MAJOR PATIENT SAFETY RISK AS IT COULD EASILY END UP IN THE PATIENT'S ABDOMEN IF IT HAD NOT BEEN NOTICED. IT LOOKS LIKE THERE IS FAR TOO LITTLE ADHESIVE ON THE SWAB.¿. THE PROCEDURE WAS COMPLETED WITH THE USE OF AN ALTERNATE VUETIP AND A DELAY OF 5 MINUTES. THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION, OR EXTENDED HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22210162 ↗
• MalfunctionOct 25, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  A SALES REPRESENTATIVE REPORTED ON BEHALF OF A CUSTOMER THAT THE LAPVUE10, LAPAROVUE VISIBILITY SYSTEM LAPAROSCOPIC SOLUTIONS DEVICE WAS BEING USED IN AN UNKNOWN PROCEDURE ON (B)(6) 2024, AND "A PIECE OF THE LAPAROVUEW CLEANER (ONE OF THE CLEANER TIPS) FELL OFF OF THE CLEANER WAND. THE SURGEON WAS ABLE TO RETRIEVE THE PIECE FROM THE PATIENT. THE ENTIRE LAPAROVUEW SYSTEM WAS REMOVED FROM USE AND A NEW ONE OBTAINED". THERE WAS NO REPORT OF INJURY, MEDICAL/SURGICAL INTERVENTION OR EXTENDED HOSPITALIZATION REQUIRED FOR THE PATIENT. THE CUSTOMER INDICATES THAT THIS EVENT WAS ALSO SUBMITTED AS MEDSUN REPORT NO. (B)(4). THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533712 ↗
• MalfunctionOct 24, 2024Material Fragmentation; Material Fragmentation

  UPDATE: MAUDE REPORT NO. (B)(4) WAS IDENTIFIED ON (B)(6) 2024, AND CONFIRMED THE FOLLOWING INFORMATION PREVIOUSLY RECEIVED: "WE HAD AN INCIDENT IN THE OPERATING ROOM (OR) DURING A ROBOTIC SLEEVE GASTRECTOMY, WHERE DURING THE PROCEDURE, THE SURGEON NOTICED A PIECE OF WHITE PLASTIC INSIDE THE ABDOMINAL CAVITY. THIS PLASTIC WAS REMOVED, AND THE TEAM SEARCHED FOR WHERE THIS PLASTIC COULD HAVE ORIGINATED FROM. THE SURGEON POINTED OUT THAT DURING THE INITIAL INSERTION OF THE LAPAROSCOPE, THEY HAD NOTICED A FUZZINESS ON THE SCOPE TIP BUT ATTRIBUTED IT INITIALLY TO TISSUE/BLOOD. THE SCOPE WAS CLEANED, AND THE ISSUE DID NOT PRESENT ITSELF AFTER THAT. THE PLASTIC INVOLVED WAS FOUND DURING THE LATTER HALF OF THE PROCEDURE. THIS OBSERVATION MADE THE TEAM LOOK AT THE SCOPE WARMER AND THROUGH MANUALLY OPENING A CLEAN SCOPE WARMER, THE SAME TYPE OF PLASTIC WAS NOTED. THE SCOPE WARMER FROM THE CASE WAS DISMANTLED AT THE REQUEST OF THE SURGEON AND MISSING PLASTIC WAS CONFIRMED. ALL PIECES HAVE BEEN SAVED IN CASE FURTHER INVESTIGATION IS NEEDED. THE ROOM WAS SEARCHED, AND OTHER SOURCES OF PLASTIC EVALUATED TO DETERMINE THE MOST LIKELY SOURCE. DURING A PROCEDURE, THE SCOPE IS INSERTED INTO THE LAPARO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20523966 ↗
• MalfunctionJan 17, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED THAT THE DEVICE, LAPVUE10, 10/CA LAPAROVUE VISIBILITY SYS, WAS BEING USED DURING AN UNKNOWN PROCEDURE ON (B)(6) 2022 WHEN IT WAS REPORTED, ¿TIP OF LAPAROVUE TROCAR CLEANING SWAB FELL OFF INTO THE PATIENT. RETRIEVED SWAB TIP.¿. THE PROCEDURE WAS COMPLETED AS PLANNED. THERE WAS NO REPORT OF INJURY, MEDICAL INTERVENTION, OR HOSPITALIZATION FOR THE PATIENT. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16182745 ↗
• MalfunctionSep 27, 2022Activation Failure

  DEFECTIVE SCOPE WARMER, NEW ONE THAT WE STARTED TO USE WOULD NOT ACTIVATE AT ALL BEFORE OR DURING THE CASE. FDA SAFETY REPORT ID# (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15498697 ↗
• MalfunctionMar 8, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, LAPVUE10, 10/CA LAPAROVUE VISIBILITY SYS WAS BEING USED ON (B)(6) 2022 DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE AND ¿A TIP OF THE PORT CLEANER CAME COMPLETELY OFF THE STICK HANDLE AND HAD TO BE RETRIEVED WITH AN INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS NO REPORT OF A DELAY TO THE PROCEDURE. THE TAMPON TIP WAS PULLED BACK OUT WITH LAPAROSCOPIC GRASPERS. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13695201 ↗
• MalfunctionNov 15, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, LAPVUE10, 10/CA LAPAROVUE VISIBILITY SYS, WAS BEING USED ON (B)(6) 2021 DURING A ROBOTIC ASSISTED TOTAL GASTRECTOMY PROCEDURE AND THE ¿THE SPONGE CAME APART WHEN PULLING IT THROUGH A TROCAR.¿ THERE WAS NO REPORT OF IMPACT OR INJURY TO THE PATIENT. THERE WAS NO REPORT OF A DELAY AND THE PROCEDURE WAS COMPLETED. AFTER FURTHER ASSESSMENT, IT WAS DISCOVERED ALL PIECES OF THE DEVICE WERE RETRIEVED WITH A LAPAROSCOPIC GRASPER. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12810968 ↗