Situate G0404-16P01C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 60 adverse event reports that list this exact device (DI 10884521700604), received between May 9, 2018 and Sep 29, 2026 — classified as 7 injuries, 53 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (37 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 18, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 60 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Frayed; Detachment of Device or Device Component

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 50938601 ↗
• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING PROCEDURE, THE GAUZE RF (RADIO FREQUENCY) TAG HAD DISLODGED. THE RF TAG HAD FELL INTO THE PATIENT'S CAVITY. IT WAS FULLY RETRIEVED AND X-RAY WAS NOT REQUIRED TO ASSIST IN LOCATING THE RF TAG. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24415644 ↗
• MalfunctionFeb 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, TESTING, THE CUSTOMER DECIDED TO DO AN EXPERIMENT AND OPENED A PACK OF 10 CT RAYTECS AND MANIPULATED THE CHIP AT THE SEAM TO SEE WHAT WOULD HAPPEN. ON 2 OUT OF THE 10 RAYTECS THE CHIP POPPED OUT EASILY THROUGH THE SEAM WITH NO PRESSURE. ON THE OTHER RAYTECS THEY COULD NOT GET THE CHIP TO POP THROUGH THE SEAM EVEN WITH PRESSURE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24414979 ↗
• MalfunctionApr 18, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE INVOLVING THE MITG RADIOFREQUENCY (RF) SURGICAL ACCESSORIES, A PIECE OR PART FELL INTO THE PATIENT'S CAVITY, WHICH WAS FULLY RETRIEVED AT THE END OF THE CASE WITHOUT THE NEED FOR AN X-RAY. THERE WAS NO ANOTHER PROCEDURE NEEDED TO REMOVE THE PIECE. ADDITIONALLY, A HOLE WAS DISCOVERED IN THE SPONGE WHEN IT WAS PULLED OUT OF THE SCROTAL SAC, PROMPTING THE SURGICAL TEAM TO SWITCH TO LAPS FOR THE REMAINDER OF THE CASE. THE GREEN SECTION OF THE SPONGE WAS FOUND WITH THE RFID TAG HANGING BY A THREAD, ABOUT TO DISLODGE. THE SURGICAL FIELD WAS SCANNED AND CLEARED AFTER THE FINAL COUNT. THERE WAS NO INJURY REPORTED AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21867780 ↗
• MalfunctionNov 1, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SURGEON STATED THAT THE RAYTECS HAD FINE FIBERS COMING OFF OF THE RAYTECS THAT THEY CAN SEE UNDER THE MICROSCOPE. THEY WERE SHREDDING AND LEAVING DEBRIS/LINT IN THE INCISION. THERE WAS NO PATIENT INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20588614 ↗
• MalfunctionNov 1, 2024Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE SURGEON STATED THAT THE RAYTECS HAVE FINE FIBERS COMING OFF OF THE RAYTECS THAT THEY CAN SEE UNDER THE MICROSCOPE. THEY WERE SHREDDING AND LEAVING DEBRIS/LINT IN THE INCISION.

  Patient problems: Insufficient Information

  MAUDE report 20587185 ↗
• MalfunctionMay 17, 2024Detachment of Device or Device Component; No Apparent Adverse Event; Detachment of Device or Device Component; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RAYTEC RIPPED WHEN BEING PULLED THROUGH THE 8MM TROCAR AND THE RF CHIP CAME OUT OF THE SPONGE BUT THEY RETRIEVED IT. THE QUALITY OF THE RF POCKET STITCHING WAS CAUSING A LACK OF TRUST IN THE PRODUCT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19343447 ↗
• MalfunctionMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE SCRUB TECH NOTICED THE RF CHIP HAD FALLEN OUT OF THE POUCH. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19282087 ↗
• MalfunctionMay 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC ROBOT ASSISTED CHOLECYSTECTOMY PROCEDURE, THE DEVICE WAS PLACED IN THE ABDOMEN TO CONTROL SOME BLEEDING. WHEN THE PA WENT TO TAKE THE DEVICE OUT OF THE 8MM PORT, THE DEVICE CAME APART INTO TWO DIFFERENT PIECES. THE DOCTOR ASSISTED ROBOTICALLY AND THEY DETERMINED THEY DID RETRIEVE THE ENTIRE SPONGE. NO FRAGMENTS OR REMNANTS OF THE SPONGE WERE SEEN UPON EXAMINATION OF THE ABDOMEN AND THE METAL 8MM TROCAR WAS FREE AND CLEAR OF ANY DEVICE PIECES. THE DOCTOR STATED THAT THE PA DID NOT PULL HARD AND DID NOT STRUGGLE WITH PULLING THE DEVICE WITH THE LAPAROSCOPIC GRASPER. UPON PHOTO OBSERVATION, IT CAN BE SEEN THAT THE DEVICE WAS TORN INTO TWO DIFFERENT PIECES. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19279761 ↗
• InjuryOct 6, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, GAUZE WAS FALLING APART AND LEAVING LINT/STRINGS IN PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17891282 ↗
• InjuryOct 6, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, GAUZE WAS FALLING APART AND LEAVING LINT/STRINGS IN PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17891225 ↗
• InjuryOct 5, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, GAUZE WAS FALLING APART AND LEAVING LINT/STRINGS IN PATIENT.

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 17883167 ↗
• MalfunctionAug 18, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, X-RAY DETECTABLE SPONGES WAS SHREDDING DURING OPERATIVE PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 17577077 ↗
• MalfunctionAug 18, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, X-RAY DETECTABLE SPONGES WAS SHREDDING DURING OPERATIVE PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 17576969 ↗
• MalfunctionAug 18, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, X-RAY DETECTABLE SPONGES WAS SHREDDING DURING OPERATIVE PROCEDURES.

  Patient problems: Insufficient Information

  MAUDE report 17576846 ↗
• MalfunctionJun 14, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE SPONGES WERE USED TO SOAK UP BODY FLUIDS AND IT WAS NOTED THAT IT WAS LINTING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17128511 ↗
• MalfunctionJun 8, 2023Fire; Fire

  ACCORDING TO THE REPORTER, DURING A CIRCUMCISION AND VASECTOMY BILATERAL PROCEDURE, THE GAUZE CAUGHT FIRE WHEN USING THE PENCIL. IT WAS NOTED THAT THERE WAS NO ALCOHOL BASED SOLUTION PREP. SUTURE OR ANY OTHER ALCOHOL ITEMS IN THE AREA OR IN THE ROOM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17087146 ↗
• MalfunctionFeb 9, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AN UNFOLDED GAUZE EXPOSED WOVEN EDGES AND RELEASED COTTON FIBERS. A LOOSE FIBERS FROM GAUZE WERE BEING LEFT IN THE PATIENT. THE FIBERS WERE REMOVED. EXPLAINED IT HAPPENED IN A FEW CASES THAT DAY. ALSO EXPLAINED THAT UNFOLDED OR MANIPULATED GAUZE CAN EXPOSE WOVEN EDGES AND RELEASE COTTON FIBERS. THE ATTACHED FILE ALSO SHOWS THAT THERE WERE FEW FIBERS DETACHED FROM THE GAUZE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16344658 ↗
• MalfunctionFeb 8, 2023Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AN UNFOLDED GAUZE EXPOSED WOVEN EDGES AND RELEASED COTTON FIBERS. A LOOSE FIBERS FROM GAUZE WERE BEING LEFT IN THE PATIENT. THE FIBERS WERE REMOVED. EXPLAINED IT HAPPENED IN A FEW CASES THAT DAY. ALSO EXPLAINED THAT UNFOLDED OR MANIPULATED GAUZE CAN EXPOSE WOVEN EDGES AND RELEASE COTTON FIBERS. THE ATTACHED FILE ALSO SHOWS THAT THERE WERE FEW FIBERS DETACHED FROM THE GAUZE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16328058 ↗
• MalfunctionFeb 8, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC PROCEDURE, THE DEVICE'S RF TAG WAS DISLODGED. A LOOSE TRANSPONDER WAS NOTICED AND WAS ABLE TO LOCATE AND EXTRACT FROM THE PATIENT. PA REMOVED THE RF CHIP WITH ROBOT GRASPER. THERE WAS NO NEED FOR ADDITIONAL MEDICAL PROCEDURE AND X-RAY TO LOCATE AND/OR RETRIEVE THE BROKEN PIECE.

  Patient problems: Insufficient Information

  MAUDE report 16326689 ↗
• MalfunctionDec 28, 2022False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, DURING PROCEDURE, THE DEVICE WAS NOT DETECTED BUT PRESENT.

  Patient problems: Insufficient Information

  MAUDE report 16064314 ↗
• MalfunctionNov 17, 2022Material Frayed; Detachment of Device or Device Component; Material Frayed; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING ROBOT ASSISTED LAPAROSCOPIC BILATERAL INGUINAL HERNIA REPAIR, THE SURGICAL TECH INSERTED AN RF DETECTABLE RAYTEC USING THE LAPAROSCOPIC GRASPER INTO THE ABDOMEN VIA AN 8MM TROCAR/PORT. IT WAS TIGHT GOING IN THROUGH THE TROCAR, WHILE PULLING THE RAYTEC IN AND OUT. WITH THE SECOND RAYTEC, THE SURGICAL TECH PULLED OUT FROM THE TROCAR AND NOTICED IT WAS FRAYED, TORN, AND THE RF MICRO CAPSULE FELL OUT FROM THE GREEN TAG, WHICH WAS ORIGINALLY ATTACHED TO ONE CORNER OF THE RAYTEC. ALL PIECES WERE ACCOUNTED FOR.

  Patient problems: Insufficient Information

  MAUDE report 15812701 ↗
• InjuryNov 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, A SPONGE WAS RETAINED INSIDE THE PATIENT. WHEN A RE-OPERATION OR ADDITIONAL SURGICAL WAS DONE, THE RETAINED SPONGE WAS REMOVED.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 15788652 ↗
• MalfunctionNov 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC CASE, THE GAUZE WAS INSERTED DOWN THE 8MM TROCAR AND THEN THE RFID TAG FELL OUT OF THE GAUZE. THE CAPSULE WAS RECOVERED. THERE WAS NO X-RAY PERFORMED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15718937 ↗
• MalfunctionSep 11, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE COTTON FIBERS FRAYED. PIECE OR PART FELL INTO PATIENT CAVITY AND WAS FULLY RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15397946 ↗