Situate G0804-12P02C-1Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10884521700833), received between Jun 22, 2020 and Sep 18, 2025 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Material Fragmentation” (9 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083776 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083757 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083712 ↗
• MalfunctionSep 18, 2025Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THE ITEM MANAGER PROCEEDED TO OPEN ONE OF THE ITEMS IN THE CASE, THE GAUZE WAS FRAYING OFF. WHEN THREE MORE RAYTEC PACKAGES WERE OPENED, ALL OF THEM LOOKED ALIKE (FRAYING OFF). 4/4 OPENED. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23083695 ↗
• MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING GAUZE; XRAY; RFD; 8X4; 12-PLY; STRL; LF, A PIECE OR PART FELL INTO THE PATIENT CAVITY. THE PIECE WAS FULLY RETRIEVED WITHOUT THE NEED FOR AN X-RAY. ADDITIONALLY, IT WAS NOTED THAT PIECES OF RAYTEC WERE FRAYING OFF. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767101 ↗
• MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A PROCEDURE INVOLVING GAUZE; XRAY; RFD; 8 X 4; 12-PLY; STRL; LF, A PIECE OR PART FELL INTO THE PATIENT CAVITY. THE PIECE WAS FULLY RETRIEVED WITHOUT THE NEED FOR AN X-RAY. ADDITIONALLY, IT WAS NOTED THAT PIECES OF RAYTEC WERE FRAYING OFF. NO MEDICAL OR SURGICAL INTERVENTION WAS NEEDED TO PREVENT A PERMANENT IMPAIRMENT OF A FUNCTION, AND THERE WAS NO INJURY AS A RESULT OF THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21767021 ↗
• InjuryNov 2, 2022Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, DURING USE, THE DEVICE FELL APART. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions; Unintended Radiation Exposure

  MAUDE report 15716548 ↗
• MalfunctionSep 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE REPORTER, INTRA OPERATIVELY, THE DEVICE CAUGHT FIRE WHEN ARCHED FROM A NON-MEDTRONIC PRODUCT MACHINE AND PENCIL TO THE SPONGE WHICH STARTED A FIRE IN THE OPERATING ROOM. THIS OCCURRED BEFORE FIRST INCISION ON THE PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15520427 ↗
• MalfunctionJul 12, 2022Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  ACCORDING TO THE REPORTER, THE BLUE XRAY STRIP WAS FRAYING/SPLINTERING/BREAKING OFF IN SMALL PIECES AND FALLING INTO THE SURGICAL/INCISION SITE.

  Patient problems: Insufficient Information

  MAUDE report 14988543 ↗
• MalfunctionJul 11, 2022Material Fragmentation; Material Frayed; Material Fragmentation; Material Frayed

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE BLUE XRAY STRIP WAS FRAYING/SPLINTERING/BREAKING OFF IN SMALL PIECES AND FALLING INTO THE SURGICAL/INCISION SITE. IT WAS REPORTED THAT THE SURGEON HAD TO PICK MULTIPLE (4) PIECES OUT.

  Patient problems: Insufficient Information

  MAUDE report 14981616 ↗
• MalfunctionJun 29, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, DURING A ROBOTIC VAGINOPLASTY PROCEDURE, THE RESIDENT PLACED RAYTEC DEVICE INTO THE TROCAR AND STARTED TO ADVANCE IT DOWN INTO THE ABDOMEN. IT WAS NOTED AS THEY BEGAN THAT THE TRACKER FROM THE RAYTEC HAD FALLEN ON TO THE DRAPES. ACTION OF ADVANCEMENT WAS DISCONTINUED IMMEDIATELY. TRACKER WAS REMOVED FROM THE FIELD. NO BLOOD TRANSFUSION WAS NECESSARY. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12086256 ↗
• MalfunctionAug 19, 2020Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, PRIOR TO PROCEDURE, PIECES OF SPONGES WERE FOUND IN THE DEVICE'S PACK. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10429172 ↗
• MalfunctionJun 30, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, PRIOR TO USE, WHEN THEY OPENED THE PACK, THEY NOTICED THAT THE GAUZE WAS FALLING APART AND UNRAVELING. A PICTURE WAS SUBMITTED WHICH SHOWED THAT THE GAUZE'S COTTON STRANDS WERE SEPARATING. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 10210460 ↗
• MalfunctionJun 22, 2020Material Fragmentation; Material Fragmentation

  ACCORDING TO THE REPORTER, THE GAUZES WERE FRAGMENTED, LEAVING PARTICLES IN THE PATIENT.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 10178816 ↗