Versaport Plus 179078PRecalls & reported problems

Summary

The FDA's MAUDE database contains 27 adverse event reports that list this exact device (DI 20884521082660), received between Aug 23, 2016 and Mar 6, 2026 — classified as 3 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Break” (13 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 27 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 6, 2026Break

  IT WAS REPORTED THAT DURING A LAPAROSCOPIC PROCEDURE, THE BALLOON BURST. THE ISSUE WAS RESOLVED BY USING A NEW PRODUCT. NO PATIENT COMPLICATIONS HAVE BEEN REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24528757 ↗
• InjurySep 15, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, AT THE TIME OF DISSECTION OF TISSUE, A VALVE-PART OF THE TROCAR WAS NOTICED INSIDE THE PATIENT CAVITY. THE PATIENT HAD BARIATRIC SURGERY LAST 2016 AND THE DEVICE REMAINED INSIDE UNTIL FOUND DURING A REDO PROCEDURE. THE SURGEON WAS ABLE TO REMOVE THE VALVE FROM THE PATIENT.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 15428910 ↗
• InjuryJul 19, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING THE LAPAROSCOPIC GASTRECTOMY, THERE WAS BREAKAGE AT THE DISTAL END OF THE CANNULA WHEN ENTERING THE TROCAR. REMOVE THE BROKEN TROCAR TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Clinical Signs, Symptoms or Conditions

  MAUDE report 15059579 ↗
• MalfunctionApr 25, 2022Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC UROLOGY PROCEDURE, WHILE AT THE BEGINNING OF THE SURGERY FOR PORT PLACEMENT, THE OB TURATOR/TROCAR WAS BROKEN. THE STAFF OPENED THE SAME PRODUCT TO COMPLETE THE CASE AND RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14197807 ↗
• MalfunctionFeb 25, 2022Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, THE TROCAR BROKE AND A PIECE OF PLASTIC FELL IN THE PATIENT'S ABDOMEN. THE SURGEON SUCCESSFULLY RETRIEVED THE COMPONENT THAT FELL OFF TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13599386 ↗
• InjurySep 13, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, WHEN OPERATING THE TROCAR, THE CANNULA TIP BROKE AND WAS NOT RETRIEVED. SURGICAL TIME WAS EXTENDED BY AT LEAST 30 MINUTES TO CHECK THE CAVITY BUT BROKEN PIECE COULD NOT BE FOUND.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 12461495 ↗
• MalfunctionApr 8, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, AT THE END OF THE COELIOSCOPY, THE SURGEON CHECKED THE SURGICAL SITE AND FOUND A SEAL IN THE PATIENT THAT HAD BECOME DETACHED FROM ITS HOUSING. THE SEAL WAS EXTRACTED FROM THE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11634046 ↗
• MalfunctionApr 1, 2020Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, THE DEVICE SEAL WAS DAMAGED AND THE SURGEON FOUND A SMALL WHITE RUBBER PIECE IN THE ABDOMEN DURING THE PROCEDURE AND WAS RETRIEVED USING GRASPER. THE SURGEON THEN USED ANOTHER DEVICE TO RESOLVE THE ISSUE IN ORDER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9909547 ↗
• MalfunctionDec 6, 2019Break; Break

  ACCORDING TO THE REPORTER, WHEN INSERTING INTO PATIENT'S SKIN DURING A PROCEDURE, THE TOP OF THE DEVICE WAS BROKEN. A NEW DEVICE WAS USED TO RESOLVED THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9432685 ↗
• MalfunctionSep 17, 2019Leak/Splash; Packaging Problem; Leak/Splash; Packaging Problem

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ADRENALECTOMY, SEAL DAMAGED WAS NOTED. THERE WAS AN AIR LEAK FROM THE SEAL. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9078476 ↗
• MalfunctionAug 6, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE TROCAR OF THE DEVICE BROKE. THERE WAS NO PATIENT INVOLVED IN THIS EVENT.

  Patient problems: No Patient Involvement

  MAUDE report 8864513 ↗
• MalfunctionMay 3, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC SLEEVE PROCEDURE, AT INSTRUMENT EXCHANGE, THE RUBBER SEAL DETACHED FROM THE REDUCER CAP AND WAS PUSHED INTO THE PATIENT'S ABDOMINAL CAVITY. THE SURGEON SAW IT AND RETRIEVED USING A GRASPER. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8578562 ↗
• MalfunctionMay 2, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN OPEN PROCEDURE, THE WHITE SEAL DISENGAGED AND FELL INTO THE CAVITY OF THE PATIENT, BUT IT WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8575756 ↗
• MalfunctionJul 30, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  DUPLICATE OF (B)(4).

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7731625 ↗
• MalfunctionJul 24, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, THE STAFF NOTICED A CHIP AT THE BOTTOM OF ONE OF THE TROCARS. THE CAMERA WAS USED TO TRY AND VISUALIZE THE PIECE IF IT WAS BROKEN OFF IN THE CAVITY OF THE PATIENT. THE CHIP WAS NOT FOUND AT THE TIME AND THE SURGEONS PROCEEDED WITH THE CASE. THE TROCAR WAS CAREFULLY REMOVED AND THE PIECE OF BROKEN OFF TROCAR WAS SEEN IN THE SUBCUTANEOUS TISSUE IN THE TROCAR SITE. THE PIECE WAS THEN REMOVED USING A GRASPER AND ALL PARTS OF THE TROCAR WERE COLLECTED AT END OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714369 ↗
• MalfunctionApr 17, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC COELIOSCOPY PROCEDURE, AFTER THE INTRODUCTION OF THE TROCAR, SHE REALIZED THAT THE TROCAR BROKE A TRIANGULAR TIP WAS MISSING. THE BROKEN END WAS FOUND IN THE PATIENT'S ABDOMEN. TO COMPLETE THE CASE, THEY REMOVED THE TIP FROM THE ABDOMEN AND REPLACED THE TROCAR WITH A OTHER DEVICE. NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7436621 ↗
• MalfunctionDec 19, 2017Detachment Of Device Component; Device Packaging Compromised; Detachment Of Device Component; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HYSTERECTOMY, THE DEVICE¿S SEAL DAMAGED. WHEN THE SURGEON USED THE SPECIMEN RETRIEVAL BAG (LARGE), THEY REALIZED THE WHITE RUBBER SEAL WAS MISSING SINCE THE TROCAR KEPT HAVING AIR LEAKS. THEY LOOKED IN THE CAVITY AND THEY FOUND IT AND RETRIEVED WITH GRASPERS. THIS HAD HAPPENED BEFORE WITH THE SAME TROCAR CODE SO THEY KNEW WHAT THE PROBLEM WAS. THE ISSUE OCCURRED ON THE LAST STEP OF THE PROCEDURE. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130624 ↗
• MalfunctionDec 19, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC BILATERAL SALPINGO-OOPHORECTOMY, THE DEVICE¿S SEAL WAS DAMAGED. THE WHITE RUBBER SEAL WAS MISSING ON THE TROCAR AFTER THEY USED A LARGE BAG TO RETRIEVE SPECIMEN. THEY REALIZED A PART OF THE TROCAR WAS MISSING SINCE THEY KEPT HAVING AIR-LEAKS. THEY REALIZED THE SEAL WAS MISSING. THEY HAD TO LOOK INSIDE THE ABDOMEN OF THE PATIENT TO FINALLY FIND THE SEAL AFTER 10 MINUTES. THERE WAS NO INJURY CAUSED TO THE PATIENT AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7130608 ↗
• MalfunctionJul 11, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, INTRAOPERATIVELY, THE CUSTOMER NOTICED THAT THE PRODUCT VALVE POPPED OFF. THERE WAS NO PATIENT INJURY INVOLVED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6700491 ↗
• MalfunctionJul 10, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A GASTRIC SLEEVE PROCEDURE. THE VALVE OF THE TROCAR POPPED OFF. TO CORRECT THE CONDITION, A NEW DEVICE WAS USED. THERE WAS NO PATIENT HARM. THE CURRENT PATIENT STATUS IS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6696458 ↗
• MalfunctionJul 7, 2017Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER: OCCURRED DURING A GASTRIC SLEEVE PROCEDURE. THE VALVE OF THE TROCAR POPPED OFF. TO CORRECT THE CONDITION, A NEW DEVICE WAS USED. THERE WAS NO PATIENT HARM. THE CURRENT PATIENT STATUS IS GOOD.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693249 ↗
• MalfunctionJul 7, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING THE GASTRIC SLEEVE PROCEDURE, THE VALVE POPPED OFF ON ALL FOUR. THERE WAS NO PATIENT INJURY INVOLVED. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6693013 ↗
• MalfunctionApr 13, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE PATIENT, DURING A GASTRIC SLEEVE PROCEDURE, THE VALVE FELL OFF WHILE USING THE DEVICE. ANOTHER DEVICE WAS USED IN OTHER TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6489967 ↗
• MalfunctionApr 6, 2017Detachment Of Device Component; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE GASTRIC SLEEVE PROCEDURE, THE VALVE FELL OFF WHILE DEVICE IN USE. TO COMPLETE THE PROCEDURE, A NEW DEVICE WAS USED. THERE WAS NO HARM CAUSED TO THE PATIENT. THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6464740 ↗
• MalfunctionApr 4, 2017Detachment Of Device Component; Detachment Of Device Component

  DURING A GASTRIC SLEEVE, THE VALVE FELL OFF WHILE THE DEVICE WAS IN USE. THERE IS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 6457994 ↗