Pediport 24055Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 10884521080829), received between Jun 1, 2016 and Aug 29, 2025 — classified as 5 injuries, 21 malfunctions.

The most frequently reported specific device problem is “Break” (15 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 29, 2025Detachment 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, IN A LAPAROSCOPIC BILATERAL INGUINAL HERNIA, WHILE INSERTING INSTRUMENTS THROUGH THE TROCARS, THE SEALS OF TWO TROCARS WERE DAMAGED. THE SEALS DISLODGED. THERE WERE DISENGAGED PIECES OF THE SEAL WHICH WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22924439 ↗
• MalfunctionAug 29, 2025Detachment 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, IN A LAPAROSCOPIC BILATERAL INGUINAL HERNIA, WHILE INSERTING INSTRUMENTS THROUGH THE TROCARS, THE SEALS OF TWO TROCARS WERE DAMAGED. THE SEALS DISLODGED. THERE WERE DISENGAGED PIECES OF THE SEAL WHICH WERE RETRIEVED. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22924218 ↗
• MalfunctionAug 28, 2025Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING THE LAPAROSCOPIC RIGHT INGUINAL HERNIA REPAIR, THE DEVICE HAD A BROKEN RUBBER STOPPER WHEN THE OBTURATOR WAS PULLED OUT. ADDITIONALLY, THERE WAS HISSING AIR INDICATING AIR OR GAS LEAKAGE FROM THE SEAL. ANOTHER PRODUCT WAS USED 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 22919464 ↗
• MalfunctionAug 7, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC INGUINAL HERNIA REPAIR, WHEN THE DEVICE WAS APPLIED ON THE TISSUE AFTER THE PNEUMOPERITONEUM WAS ESTABLISHED, THE PORT WAS INSERTED UNDER VISION. A SMALL WHITE PIECE OF PLASTIC WAS OBSERVED FALLING FROM THE PORT AND FELL INTO THE PATIENT¿S CAVITY. THE SURGEON REMOVED THE LOOSE WHITE PLASTIC FROM THE CAVITY BY USING A REUSABLE LAPAROSCOPIC GRASPER. THE SURGEON ALSO NOTED THAT THE PORT WAS LEAKING GAS. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22738613 ↗
• MalfunctionOct 8, 2019Break; Break

  ACCORDING TO THE REPORTER, LAPAROSCOPIC TOTALLY EXTRAPERITONEAL HERNIA PROCEDURE, THE CANNULA BROKE UPON DEPLOYING AND SECURING TO THE ABDOMINAL WALL. THE CANNULA BROKE INTO THE PATIENT AND THE SURGEON WAS ABLE TO RETRIEVE THE BROKEN PIECE USING A LAPAROSCOPIC GRASPER . ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9169839 ↗
• MalfunctionFeb 1, 2019Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC COLORECTAL CASE, A PIECE OF THE PLASTIC EXPANDABLE HUB BROKE OFF INTO THE PATIENT. THE PIECE WAS RETRIEVED USING THE GRASPERS AND THE CASE WAS COMPLETED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8297836 ↗
• MalfunctionJul 16, 2018Break; Material Twisted/Bent; Break

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, WHEN REMOVING THE TROCARS, UPON CLOSURE OF THE DEVICE, THE PLASTIC ANCHORS WERE TWISTING IN UNUSUAL MANNER AND ALMOST BROKE OFF. AFTER IT WAS SAFELY REMOVED, ALL PIECES WERE PRESENT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 7691175 ↗
• InjuryJul 16, 2018Break; Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC PROCEDURE, WHEN THEY WERE REMOVING THE DEVICE, THERE WAS A PIECE OF THE TROCAR, "A LOCKING PRONG". THAT BROKE OFF INTO THE PATIENT AND COULD NOT BE RETRIEVED. THE ISSUE HAPPENED AT THE END OF THE CASE. THERE WAS NO PATIENT INJURY.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7691170 ↗
• MalfunctionJun 21, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, PLASTIC SLATS BROKE INSIDE THE PATIENT'S BODY. THEY WERE ABLE TO RETRIEVE THE PIECES FROM WITHIN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625750 ↗
• MalfunctionJun 21, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, PLASTIC SLATS BROKE INSIDE THE PATIENT'S BODY. THEY WERE ABLE TO RETRIEVE THE PIECES FROM WITHIN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625635 ↗
• MalfunctionJun 21, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING THE PROCEDURE, PLASTIC SLATS BROKE INSIDE THE PATIENT'S BODY. THEY WERE ABLE TO RETRIEVE THE PIECES FROM WITHIN THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7625618 ↗
• MalfunctionApr 24, 2018Break; Detachment Of Device Component; Break; Detachment Of Device Component

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC HERNIA REPAIR, WHILE THE TROCAR WAS BEING REMOVED AT THE END OF THE CASE, THE DEVICE BROKE. SOME OF THE PLASTIC TABS THAT HOLD THE TROCAR IN PLACE SEPARATED FROM THE DEVICE AND FELL INTO THE PATIENT. TO RESOLVE THE ISSUE, THE SURGEON REMOVED THE PLASTIC TABS FROM THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7454775 ↗
• MalfunctionApr 23, 2018Break; Device Packaging Compromised; Break; Device Packaging Compromised

  ACCORDING TO THE REPORTER, PRE OPERATIVELY, THE CANNULA BROKE, THE ANCHORING PORTION OF THE TROCAR WAS BROKEN BEFORE USAGE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 7451086 ↗
• MalfunctionMar 2, 2018Break; Difficult to Remove; Break; Difficult to Remove

  ACCORDING TO THE REPORTER: OCCURRED DURING A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY (LAVH) PROCEDURE. THE PORT WAS INSERTED INTO THE SKIN. AT THE COMPLETION OF THE PROCEDURE AN ISSUE WAS DISCOVERED, THE SURGEON COULD NOT CLOSE THE FLANGE TO REMOVE THE TROCAR FROM THE PATIENT. THE CANNULA BROKE. THE SURGICAL TIME WAS EXTENDED BY MORE THAN THIRTY MINUTES DUE TO THE PRODUCT PROBLEM. IN ORDER TO RESOLVE THE ISSUE AND COMPLETE THE CASE, THE SURGEON MADE A LONGER INCISION (EXTENDED BY LESS THAN ONE INCH) TO REMOVE THE PRODUCT. THERE WAS NO PATIENT HARM. THE PATIENT HAS NO INJURY.

  Patient problems: No Code Available; No Known Impact Or Consequence To Patient

  MAUDE report 7309696 ↗
• MalfunctionFeb 28, 2018Leak/Splash; Leak/Splash

  ACCORDING TO THE REPORTER, DURING TEPP INGUINAL HERNIA LAPAROSCOPIC PROCEDURE, THE DEVICES HAD AIR OR GAS LEAKED FROM THE SEAL. THEY HAD LEAK AT THE TOP WHERE THE INSTRUMENT WENT IN. NEW DEVICE WAS USED TO COMPLETE THE CASE. 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 7302636 ↗
• MalfunctionFeb 6, 2018Break; Break

  ACCORDING TO THE REPORTER, PRIOR TO USE, ON PREPPING OF THE CASE, THE DEVICE PLASTIC FLANGES AT THE BASE BROKE APART. THERE WAS NO REPORTED PATIENT INVOLVEMENT AND OUTCOME.

  Patient problems: No Patient Involvement

  MAUDE report 7245420 ↗
• MalfunctionDec 6, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE WAS NO CUSTOMER REPORTED CONDITION. THE DEVICE WAS RETURNED AND EVALUATION FOUND THAT THE FLANGES OF THE ANCHORS ON THE DEVICE WERE SKEWED AND BROKEN. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7086789 ↗
• InjuryNov 15, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOTIC PROSTATECTOMY PROCEDURE, THE FLANGES ON THE DISTAL END OF THE DEVICE BROKE OFF LEAVING PLASTIC SHARDS IN THE WOUND - THEY WERE RETRIEVED WITH GRASPERS - THE NURSE IS NOT SURE IF ALL PARTS WERE RETRIEVED. A SURGICAL INTERVENTION WAS NEEDED - PLASTIC SHARDS HAD TO BE REMOVED FROM THE WOUND. THERE WAS A TEMPORARY INJURY - THE PLASTIC SHATTERED LEAVING SHARDS IN THE WOUND. THERE WAS TISSUE DAMAGE - THEY HAD TO DIG THE SHARDS OUT OF THE SURROUNDING TISSUE OF THE PORT SITE.

  Patient problems: Injury; No Code Available; Tissue Damage

  MAUDE report 7033099 ↗
• MalfunctionOct 19, 2017Break; Break

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE, UPON ENTRY INTO THE PATIENT, THE UNIT'S CANNULA ON ALL PORTS BROKE AND FELL APART. THEY REPLACED IT WITH ANOTHER PRODUCT TO COMPLETE THE CASE. THE PATIENT IS ALIVE WITH NO INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6961206 ↗
• MalfunctionAug 22, 2017Break; Break

  A PATIENT WAS SCHEDULED FOR LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR WITH MESH PLACEMENT. THE SURGEON INTRODUCED THE AUTO SUTURE LOCKING TROCAR AND WHEN SHE ATTEMPTED TO LOCK THE DEVICE IN PLACE, THE "ANCHORS" BROKE RENDERING THE DEVICE INOPERABLE. A SECOND DEVICE WITH THE SAME LOT NUMBER WAS USED, BUT RESULTED IN THE SAME DEFECT. A THIRD DEVICE WAS OPENED, INTRODUCED AND WAS SUCCESSFULLY DEPLOYED, AT WHICH POINT THE SURGERY PROCEEDED AS PLANNED. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6811495 ↗
• MalfunctionAug 17, 2017Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, BOTH DEVICES BROKE ON THE PATIENT. NO PATIENT INJURY HAS BEEN NOTED. MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6800732 ↗
• MalfunctionAug 16, 2017Packaging Problem; Packaging Problem

  ACCORDING TO THE REPORTER, BOTH DEVICES BROKE ON THE PATIENT. NO PATIENT INJURY HAS BEEN NOTED. MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6798538 ↗
• InjuryAug 16, 2017Break; Detachment Of Device Component; Mechanical Problem; Packaging Problem; Break; Detachment Of Device Component; Mechanical Problem; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE DEVICE SEAL DISENGAGED, CANNULA AND OBTURATOR BROKE, THE PRODUCT PARTS DISINTEGRATED AND SURGEON WAS UNABLE TO RETRIEVE ALL PIECES. A NEW PRODUCT WAS OPENED BUT IT COLLAPSED, A FORTH (4TH) WAS OPENED AND WORKED TO COMPLETE THE CASE. THE PATIENT IS ALIVE WITH INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6796659 ↗
• InjuryAug 15, 2017Break; Detachment Of Device Component; Packaging Problem; Break; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC HERNIA REPAIR, THE DEVICE SEAL DISENGAGED, CANNULA AND OBTURATOR BROKE, THE PRODUCT PARTS DISINTEGRATED AND SURGEON WAS UNABLE TO RETRIEVE ALL PIECES. A NEW PRODUCT WAS OPENED BUT IT COLLAPSED, A FORTH (4TH) WAS OPENED AND WORKED TO COMPLETE THE CASE. THE PATIENT IS ALIVE WITH INJURY.

  Patient problems: Device Embedded In Tissue or Plaque; No Known Impact Or Consequence To Patient; Radiation Exposure, Unintended

  MAUDE report 6795297 ↗
• MalfunctionJun 12, 2017Detachment Of Device Component; Packaging Problem; Detachment Of Device Component; Packaging Problem

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC PROCEDURE THE OBTURATOR/TROCAR OF THE DEVICE BROKE. THE DEVICE WAS "DISCOVERED TO HAVE CRACKS IN THE TROCAR". THIS TROCAR HAS BEEN ON SITE FOR OVER TWO YEARS BUT THE EXPIRATION DATE WAS STILL GOOD. THE WAS NO PATIENT INJURY REPORTED IN THIS EVENT. THERE WAS NO PATIENT HARM OR INJURY DUE TO THE EXPANDING MUSHROOM-SHAPED STABILIZER BREAKING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6635041 ↗