Situate G0404-32P01C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10884521700819), received between Mar 6, 2020 and Jun 26, 2024 — classified as 2 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryJun 26, 2024Material Fragmentation; Detachment of Device or Device Component; Material Fragmentation; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING AN ORTHOPEDIC RIGHT TOTAL KNEE REVISION, THE SURGEON PACKED THE BONE LUMEN WITH THE RAYTEC DEVICE. DURING THE CASE, THEY WERE MISSING A SPONGE, SO THEY SCANNED THE PATIENT AND THE SCAN WAS CLEAR. THEREFORE, THEY ASSUMED THAT THE PATIENT WAS CLEAR AND IT WAS POSSIBLY IN THE TRASH. AT THE END OF THE CASE, THEY PERFORMED AN X-RAY AND FOUND THE SPONGE IN THE BONE LUMEN. THE NEXT DAY THEY BROUGHT THE PATIENT BACK TO THE OPERATING ROOM TO FINISH THE PROCEDURE. AFTER RETRIEVING THE SPONGE, THE POUCH WAS DAMAGED, AND THEY WERE ABLE TO PULL THE CHIP OUT THAT ALSO LOOKED TO BE DAMAGED, THE CHIP FELL OUT AND WAS NOT RESONATING WHEN SCANNED OUTSIDE THE BODY. PHOTO WAS SUBMITTED SHOWING THE CHIP OF THE DEVICE WAS BROKEN/DETACHED FROM THE SPONGE AND SPONGE FIBER COMING OFF.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 19614238 ↗
• InjuryFeb 22, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING PROCEDURE, RADIOFREQUENCY IDENTIFICATION (RFID) CAME OUT OF ITS POCKET AND WAS RETAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 13577000 ↗
• MalfunctionOct 4, 2021Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY REMOVAL OF AXILLARY MASS, THE X-RAY SPONGE HAD LINTING AND SHREDDING. CAME OFF ON PATIENT'S. SURGEON MANUALLY REMOVED THE THREAD OF THE GAUZE FROM SURGICAL SITE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12572896 ↗
• MalfunctionAug 11, 2021Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING BREAST SURGERY REMOVAL OF AXILLARY MAS, THE X-RAY SPONGE WAS LINTING/SHREDDING. CAME OFF ON PATIENT'S SKIN. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12309842 ↗
• MalfunctionJan 26, 2021Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE X-RAY GAUZE SHREDS WHEN USING INSTRUMENTS TO MANIPULATE THEM. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11230442 ↗
• MalfunctionJan 26, 2021Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING OPEN HERNIA REPAIR, THE X-RAY GAUZE SHREDS WHEN USING INSTRUMENTS TO MANIPULATE THEM. THE PROCEDURE WAS COMPLETED BY REMOVING SHREDS FROM THE WOUND. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11228733 ↗
• MalfunctionJan 14, 2021Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE GAUZE WAS SHEDDING WHITE FIBERS WHEN THE STAFF WAS OPENING IT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11169419 ↗
• MalfunctionDec 5, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE RADIO FREQUENCY (RF) BEAD RIPPED OUT OF A SPONGE AND FELL INTO THE BELLY OF A PATIENT. A PHOTO SUBMITTED SHOWED THAT THE RF BEAD WAS RETRIEVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10950318 ↗
• MalfunctionSep 3, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE GAUZE WAS SHREDDING. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 10488802 ↗
• MalfunctionJul 8, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THEY HAD POOR QUALITY OF GAUZE. LITTLE STRINGS PULLED OUT OF THE PATIENT. A PHOTO SUBMITTED SHOWED A TINY PIECE OF STRAND COMING FROM THE GAUZE. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10245008 ↗
• MalfunctionMar 6, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING USE, THE STAFF WERE USING THE DEVICE ON THE BACK TABLE DURING THE CASE AND DIDN¿T USE THESE ON THE PATIENT BECAUSE THEY WERE FALLING APART. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 9799958 ↗