Versaport Plus NB12STFRecalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10884521076495), received between Jun 20, 2017 and Aug 21, 2024 — classified as 2 injuries, 16 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC VERTICAL GASTRECTOMY, AFTER FIRING A RELOAD, THE SEAL WAS DAMAGED. TO RESOLVE THE ISSUE, A NEW DEVICE WAS USED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20020119 ↗
• MalfunctionJun 17, 2024Material Split, Cut or Torn; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE THE TROCAR SEAL WAS DAMAGED, THERE WERE ALSO TWO RELOADS REPORTED TO HAVE MALFUNCTIONED. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19547880 ↗
• MalfunctionMay 10, 2024Break; Break

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, WHEN A DISPOSABLE BLADELESS PUNCTURE APPARATUS WAS USED TO MAKE A HOLE, THE INTERFACE OF THE PUNCTURE WAS BROKEN AND THE SURGERY COULD NOT BE PERFORMED. THE DEVICE WAS REPLACED WITH A NEW PUNCTURE APPARATUS IMMEDIATELY, THE SURGERY CONTINUED, AND THE PATIENT RETURNED TO THE WARD SAFELY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19288682 ↗
• MalfunctionMay 1, 2024Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO LOBECTOMY, JUST UNPACKED AND HAD NOT BEEN INSERTED INTO THE BODY YET, THE INNER CORE WAS PUNCTURED. THE USER REPLACED THE SHEATH CARD FOR PUNCTURE TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19220833 ↗
• MalfunctionFeb 7, 2024Break; Difficult to Insert; Break; Difficult to Insert

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTRIC SLEEVE, WHEN MOUNTING THE PUNCH IN THE CANNULA, IT GOT STUCK. THE SURGEON TRIED TO INSERT THE PUNCH BUT IT DID NOT ADVANCE. THE SURGEON THEN REMOVED THE TROCAR AND WHILE REMOVING IT, THE TROCAR BROKE. ANOTHER DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18661600 ↗
• MalfunctionDec 14, 2023Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE DOCTOR WAS PERFORMING A KIDNEY TRANSPLANT, THERE WAS AN AIR OR GAS LEAKED FROM THE SEAL, THE TROCAR MEMBRANE RUPTURE. A NEW DEVICE WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18332095 ↗
• MalfunctionDec 6, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON PLACED THE DEVICE IN THE TROCAR, IT GOT STUCK IN THE MIDDLE, IT DID NOT GO THROUGH THE SEAL. ANOTHER TROCAR WAS USED, THE DEVICE STILL DID NOT PASS THROUGH. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278617 ↗
• MalfunctionDec 6, 2023Difficult to Remove; Difficult to Remove

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, WHEN THE SURGEON PLACED THE DEVICE IN THE TROCAR, IT GOT STUCK IN THE MIDDLE, IT DID NOT GO THROUGH THE SEAL. ANOTHER TROCAR WAS USED, THE DEVICE STILL DID NOT PASS THROUGH. A NEW TROCAR WAS USED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18278456 ↗
• MalfunctionMay 27, 2022Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, WHEN THE USER PUNCTURED INTO THE TROCAR, THE SEAL WAS DAMAGED AND DISENGAGED, THE CANNULA DETACHED FROM THE TOP PORTION OF THE PORT. THE PRODUCT WAS REPLACED TO RESOLVE THE ISSUE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14526676 ↗
• MalfunctionOct 24, 2020Detachment of Device or Device Component; Packaging Problem; Detachment of Device or Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPY, THE DUCKBILL SEAL AND CIRCULAR SEAL WERE INTACT. THE CANNULA DISENGAGED FROM THE TROCAR. THE USER TOOK ANOTHER TROCAR TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10731922 ↗
• MalfunctionAug 27, 2019Mechanical Problem; Detachment of Device or Device Component; Mechanical Problem; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC GYNECOLOGICAL SURGERY, THE KNIFE BLADE WAS DIFFICULT TO ADVANCE. ALSO, THE LENS DISENGAGED WHICH WAS LOCATED WHEN THE BRINE WAS RINSE. TWEEZERS WERE USED TO REMOVE THE LENS. SURGICAL TIME WAS EXTENDED FOR 30 MINUTES OR MORE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 8936638 ↗
• MalfunctionAug 26, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO THE LAPAROSCOPIC STOMACH CANCER PROCEDURE, THE DEVICE'S LENS WAS DISENGAGED. A NEW DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8933146 ↗
• MalfunctionMay 10, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, WHILE BEING APPLIED ON ABDOMINAL WALL PUNCTURE COMPLETED DURING A LAPAROSCOPIC CHOLECYSTECTOMY, THE THREADED SLEEVE WAS DISCONNECTED FROM THE BASE. ANOTHER TROCAR WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8600876 ↗
• MalfunctionMar 29, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC CYSTECTOMY PROCEDURE, THE SEAL WAS DAMAGED. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464642 ↗
• MalfunctionJan 18, 2019Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC RADIAL GASTRECTOMY, WHEN THE PACKAGE WAS OPENED, THE CORE TIP OF THE PIERCER WAS BROKEN. REPLACEMENT OF THE SURGICAL INSTRUMENT WAS DONE TO COMPLETE THE PROCEDURE. THERE IS NO PATIENT INJURY.

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

  MAUDE report 8262212 ↗
• InjuryDec 5, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC APPENDIX PROCEDURE, THE OBTURATOR/TROCAR BROKE. A MEDICAL INTERVENTION WAS NEEDED - THE TINY LITTLE PIECES OF COLOR FROM THE TROCAR DAME HAD TO BE REMOVED FROM THE PERITONEUM - THEY WERE CUT OUT OF THE TISSUE. THERE WAS TISSUE LOSS AND TISSUE DAMAGE.

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 7085542 ↗
• InjuryAug 10, 2017Detachment Of Device Component; Packaging Problem; Appropriate Device Problem Term/Code Not Available; Detachment Of Device Component; Packaging Problem; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE REPORTER: DURING A LAPAROSCOPIC PROCEDURE, THE DEVICE THE OBTURATOR/ TROCAR BROKE. PROCEDURE CONVERTED TO OPEN PROCEDURE. A DEVICE ONCE IT WAS PUSHED THROUGH THE PATIENT'S ABDOMEN THE WHITE TIP THAT RETRACTS OUT OF THE SHEATH WHILE PRESSURE WAS BEING EXERTED SNAPPED OFF. THIS WHITE PIECE OF PLASTIC HAS NOT BEEN ABLE TO BE RECOVERED AFTER AN X-RAY AND FURTHER SURGERY WAS NEEDED TO OPEN PATIENT TO TRY AND FIND THE OBJECT. THE SURGICAL TIME EXTENDED 30 MINUTES OR MORE DUE TO THE PRODUCT PROBLEM. BOTH TIMES THE PLASTIC HAS NOT BE LOCATED. THERE WAS PERMANENT TISSUE DAMAGE AS A RESULT OF THIS PROBLEM. THE INCISION WAS EXTENDED MORE THAN 1 INCH (2.54 CM). NO PATIENT INJURY HAS BEEN NOTED.

  Patient problems: No Code Available; Radiation Exposure, Unintended; Tissue Damage

  MAUDE report 6784560 ↗
• MalfunctionJun 20, 2017Difficult to Insert; Device Packaging Compromised; Difficult to Insert; Device Packaging Compromised

  ACCORDING TO THE REPORTER, DURING A ROBOTIC LAPAROSCOPIC CHOLECYSTECTOMY PROCEDURE, THERE WAS A DAMAGED SEAL ON THE DEVICE. IT WAS SUSPECTED THAT THE UNIT SEAL WAS MISALIGNED SO IT WAS DIFFICULT TO PUT THE ROBOTIC CAMERA IN. TO COMPLETE THE PROCEDURE, THE TROCAR WAS USED AND THE CAMERA FINALLY WENT THROUGH THE TROCAR. THE PATIENT IS ALIVE AND DID NOT SUFFER ANY INJURIES FROM THIS EVENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6654111 ↗