Situate 01-0043Recalls & reported problems

Summary

The FDA's MAUDE database contains 94 adverse event reports that list this exact device (DI 10884521700703), received between Aug 15, 2017 and Apr 7, 2026 — classified as 21 injuries, 73 malfunctions.

The most frequently reported specific device problem is “False Positive Result” (69 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 25 most recent of 94 reports, in the reporter's own words as published by the FDA.

• InjuryApr 7, 2026False Negative Result

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THERE WAS A RETAINED SPONGE.

  Patient problems: Foreign Body In Patient

  MAUDE report 24799922 ↗
• InjuryApr 6, 2026False Negative Result

  IT WAS REPORTED THAT THERE WAS A RETAINED SPONGE.

  Patient problems: Foreign Body In Patient; Pain

  MAUDE report 24791106 ↗
• MalfunctionJun 23, 2025False Positive Result; Device Displays Incorrect Message; False Positive Result; Device Displays Incorrect Message

  IT WAS REPORTED THAT AT THE END OF THE PROCEDURE, PRIOR TO CLOSURE, THE CONSOLE WAS SIGNALING FOR AN RFO (RETAINED FOREIGN OBJECT) BUT NONE WERE LOCATED, AND A SYSTEM ERROR OCCURRED. USED A NEW CONSOLE AND NO RFO WAS DETECTED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22307166 ↗
• InjuryJun 9, 2025False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER DURING PROCEDURE, THE CONSOLE WAS READING SPONGE IN PATIENT. THEY HAD PATIENT X-RAYED AND THERE WAS NO SPONGE DETECTED.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 22171740 ↗
• InjuryApr 30, 2025False Negative Result; False Negative Result

  IT WAS REPORTED THAT POST-OPERATIVELY, A NON-MEDTRONIC LAPAROTOMY SPONGE WAS RETAINED IN THE PATIENT FOLLOWING A SURGICAL PROCEDURE, NECESSITATING A SECOND SURGERY TO RETRIEVE THE SPONGE. THE RETAINED SPONGE RESULTED IN EXTENDED THE PATIENT'S HOSPITALIZATION BY 3-4 DAYS. AN X-RAY WAS TAKEN TO ASSIST IN LOCATING THE RETAINED SPONGE. AND THE PATIENT WAS INITIALLY TAKEN TO THE INTENSIVE CARE UNIT BUT HAD TO RETURN DUE TO COMPLICATIONS. THE SPONGE WAS FULLY RETRIEVED DURING THE SECOND SURGERY. IT WAS NOTED THAT THE SPONGE COUNT WAS CORRECT AND MACHINE READ A CORRECT COUNT AT THE END OF THE INITIAL PROCEDURE BUT DID NOT DETECT A SPONGE WAS IN THE PATIENT.

  Patient problems: Foreign Body In Patient; Unintended Radiation Exposure

  MAUDE report 21932058 ↗
• MalfunctionMar 24, 2025Computer Software Problem; Image Display Error/Artifact; Computer Software Problem; Image Display Error/Artifact

  IT WAS REPORTED THAT A SOFTWARE FAILURE AND BLACK SCREEN OCCURRED. THERE WAS NO PATIENT INVOLVED. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT THE RIBBON CABLE ON THE ANALOG BOARD WAS FOUND TO BE LOOSE. THE CABLE WAS RESEATED AND THE UUT WAS POWER CYCLE ON COMPLETING POST WITHOUT PRODUCING ANY ERRORS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21679973 ↗
• InjuryJan 20, 2025False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING PROCEDURE, AS SURGERY WAS BEING WRAPPED UP THE SCANNING DEVICES WAS KEPT GETTING FLIP-FLOPPED RESULTS OF CLEAR VS DETECTION, AS SOMETHING BETWEEN THE MAT AND WAND WAS COMING UP UNCLEAR. MAT WAS SAYING "DETECTION" AND WAND WAS NOT DETECTING ANYTHING. THEY NEEDED TO ORDER AN X-RAY TO DETERMINE FINAL DIAGNOSTICS. X-RAY WAS NEGATIVE. THERE WAS UNNECESSARY RADIATION DUE TO PROLONGED USE OF PRODUCT. THE MAT WAS PLUGGED IN WITH THE REPRESENTATIVE ON SIDE THE MAT FAILED IMMEDIATELY UPON THE CONSOLE TURNING ON.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 21191495 ↗
• MalfunctionJan 9, 2025False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, THE CONSOLE WOULD GIVE A CLEAR SCAN ON ANY PATIENT. JUST A YELLOW OBSTRUCTION ISSUE FOR EVERY PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 21114782 ↗
• MalfunctionJan 9, 2025False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, THE CONSOLE WOULD GIVE A CLEAR SCAN ON ANY PATIENT. JUST A YELLOW OBSTRUCTION ISSUE FOR EVERY PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21114252 ↗
• MalfunctionNov 27, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE CONSOLE WAS DETECTING METAL EVEN WITH NO PATIENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20798851 ↗
• MalfunctionOct 17, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE UNIT WAS DETECTING METAL WHEN THERE WAS NO METAL. A NEW CONSOLE WAS USED WITH THE SAME HANDPIECE AND IT WORKED FINE THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20471498 ↗
• MalfunctionAug 22, 2024False Positive Result; Device Displays Incorrect Message; False Positive Result; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, THE CONSOLE HAD A SYSTEM ERROR. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT MULTIPLE SCANS WERE ATTEMPTED WITH THE TEST BLAIR-PORT WAND, THE DEVICE ALERTED FOR METAL PRESENCE EACH SCAN/FALSE DETECTION. REPLACED ANALOGUE BOARD IN THE CONSOLE AND ALL SCAN WITH THE BLAIR PORT WAND WERE CLEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20042309 ↗
• MalfunctionAug 20, 2024False Positive Result; Device Displays Incorrect Message; False Positive Result; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, THE CONSOLE HAD SYSTEM ERROR. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT MULTIPLE SCANS WERE ATTEMPTED WITH THE BLAIR-PORT WAND, THE DEVICE ALERTED FOR METAL PRESENCE EACH SCAN/FALSE DETECTION .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20008553 ↗
• MalfunctionJul 10, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, CUSTOMER WAS SCANNING THE ROOM AND GOT A DETECTION WHEN THERE WAS NO CHIP PRESENT. THERE WAS NO PATIENT INJURY.

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

  MAUDE report 19713658 ↗
• MalfunctionJul 10, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, CUSTOMER WERE SCANNING THE ROOM AND GOT A DETECTION WHEN THERE WAS NO CHIP PRESENT. THERE WAS NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19713060 ↗
• InjuryJun 28, 2024False Negative Result; False Negative Result

  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 OR 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 19637030 ↗
• InjuryJun 20, 2024False Positive Result; Insufficient Device Problem Information; False Positive Result; Insufficient Device Problem Information

  ACCORDING TO THE REPORTER, POST-OPERATIVELY ON PATIENT IN SUPINE POSITION, THE COUNT WAS CORRECT BUT WHEN THE MAT WAS USED, IT REVEALED DETECTION AGAIN. THE STAFF USED THE WAND TO VERIFY THE COUNT AND THE MACHINE (SERIAL#:(B)(6)) CLEARED THE READING. RFA DETECTION WAS CLEAR BUT THE OTHER(MAT) WAS POSITIVE. CALLED PATIENT AND DISCUSSED THE ISSUE. PATIENT HAD AN X-RAY AND NEGATIVE FOR RETAINED FOREIGN BODY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19575934 ↗
• InjuryJun 20, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ADRENALECTOMY. INITIALLY, THE RF MAT WAS UNINTENTIONALLY FOLDED DURING POSITIONING. AFTER THE CASE, THE MAT WAS USED BUT IT SHOWED DETECTION EVEN WHEN THE SPONGE COUNTS WERE CORRECT WITH RF MACHINE X18ASQ. A REPLACEMENT MACHINE WAS USED X18AOY WITH THE SAME MAT WHICH ALSO REVEALED DETECTION. THE STAFF USED THE WAND WHICH CLEARED THE COUNT BUT PER POLICY, AN X-RAY WAS TAKEN (NEGATIVE) WHICH DELAYED THE CASE. THE MAT WAS CHECKED WHICH RESULTED IN CLEAR READING. ON THE NEXT PROCEDURE WITH THE SAME PATIENT, PATIENT WAS ON SUPINE POSITION AND THE SAME MAT WAS USED. AFTER THE CASE, THE COUNT WAS CORRECT BUT WHEN THE MAT WAS USED, IT REVEALED DETECTION AGAIN. THE STAFF USED THE WAND TO VERIFY THE COUNT AND THE MACHINE X18AOY CLEARED THE READING. SPONGE, NEEDLE AND INSTRUMENT COUNTS WERE REPORTED TO BE CORRECT TWICE AND ALL RFA INTACT. EVENTUALLY, ONE OF THE MAT WAS MALFU NCTIONING WHICH HAD CLEAR DETECTION BUT THE OTHER(MAT) WAS POSITIVE. XRAYS WERE NEGATIVE FOR RETAINED FOREIGN BODY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19575846 ↗
• InjuryJun 20, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING LAPAROSCOPIC ADRENALECTOMY. INITIALLY, THE RF MAT WAS UNINTENTIONALLY FOLDED DURING POSITIONING. AFTER THE CASE, THE MAT WAS USED BUT IT SHOWED DETECTION EVEN WHEN THE SPONGE COUNTS WERE CORRECT WITH RF MACHINE X18ASQ. A REPLACEMENT MACHINE WAS USED X18AOY WITH THE SAME MAT WHICH ALSO REVEALED DETECTION. THE STAFF USED THE WAND WHICH CLEARED THE COUNT BUT PER POLICY, AN X-RAY WAS TAKEN (NEGATIVE) WHICH DELAYED THE CASE. THE MAT WAS CHECKED WHICH RESULTED IN CLEAR READING. ON THE NEXT PROCEDURE WITH THE SAME PATIENT, PATIENT WAS ON SUPINE POSITION AND THE SAME MAT WAS USED. AFTER THE CASE, THE COUNT WAS CORRECT BUT WHEN THE MAT WAS USED, IT REVEALED DETECTION AGAIN. THE STAFF USED THE WAND TO VERIFY THE COUNT AND THE MACHINE X18AOY CLEARED THE READING. SPONGE, NEEDLE AND INSTRUMENT COUNTS WERE REPORTED TO BE CORRECT TWICE AND ALL RFA INTACT. EVENTUALLY, ONE OF THE MAT WAS MALFU NCTIONING WHICH HAD CLEAR DETECTION BUT THE OTHER(MAT) WAS POSITIVE. X-RAYS WERE NEGATIVE FOR RETAINED FOREIGN BOD.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 19575791 ↗
• MalfunctionJun 11, 2024False Positive Result; Device Displays Incorrect Message; False Positive Result; Device Displays Incorrect Message

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE CONSOLE HAD AN ACCESSORY ERROR MESSAGE. THERE WAS NO PATIENT INVOLVEMENT. MEDTRONIC'S INITIAL EVALUATION OF THE INCIDENT DEVICE FOUND THAT WHEN CONNECTING THE BLAIR PORT II WAND, THE ACCESSORY ERROR MESSAGE WAS OBSERVED AND FALSE DETECTION WAS OBSERVED WHEN CONNECTING THE ARQSPHERE ACCESSORY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19513902 ↗
• InjuryMar 1, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE DEVICE GAVE A ¿DETECTION¿ MESSAGE WHEN THE AREA WAS ALL CLEAR OF SPONGES TWICE. ON A THIRD ATTEMPT, IT GAVE A ¿CLEAR¿ MESSAGE. AN X-RAY WAS PERFORMED AS A PRECAUTIONARY MEASURE TO CONFIRM CLEARANCE.

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

  MAUDE report 18816354 ↗
• MalfunctionFeb 22, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE UNIT IS DETECTING ON THE TABLE WHEN NOTHING IS PRESENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18763886 ↗
• MalfunctionFeb 21, 2024False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, THE CONSOLE HAD READ DETECTION WHEN NO ONE WAS ON THE TABLE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18754997 ↗
• MalfunctionFeb 19, 2024False Positive Result; No Apparent Adverse Event; False Positive Result; No Apparent Adverse Event

  ACCORDING TO REPORTER, DURING A PROCEDURE, DEVICE¿S COUNT WAS DETERMINED CORRECT MULTIPLE TIMES MANUALLY. THE SITUATE WAND WAS USED TO VALIDATE CLEAR CODE AND PROPER COUNT #. IT WAS THEN USED AS AN ADJUNCT AND SHOWED A DETECTION, ALTHOUGH NO COTTON WAS LEFT BEHIND. (FALSE POSITIVE). STERIS 4085 BED POTENTIALLY CAUSING ELECTRICAL NOISE LEAKAGE CAUSING INTERFERENCE WITH MAT. MAT WAS RAN AGAIN AND GAVE FALSE POSITIVE, POTENTIAL REPLACEMENT.

  Patient problems: Insufficient Information

  MAUDE report 18730862 ↗
• MalfunctionSep 15, 2023False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT SHOWED DETECTION WHEN NO COTTON WAS PRESENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17760936 ↗