Situate 01-0046Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 10884521700727), received between Jan 31, 2019 and Jun 28, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “False Negative Result” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 19637587 ↗
• InjuryAug 16, 2023False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, POST ROBOTIC HYSTERECTOMY, SCANNED THE PATIENT DURING THE SURGICAL PROCEDURE AND RECEIVED A CLEAR CODE OF 1275C. WHEN THE PATIENT CAME BACK ON (B)(6) 2023 WITH AN ODOR AND BLEEDING. WHEN SCANNED AGAIN, THE SITUATE SYSTEM ALERTED TO A DETECTION. A SPONGE WAS FOUND IN VAGINAL CANAL. THE DETECTION WAS REPEATED THREE TIMES TO VERIFY SPONGE EXISTED IN THE PATIENT. THE FINAL SPONGE COUNT DURING THE INITIAL PROCEDURE. SPONGE WAS THEN REMOVED. X-RAY PERFORMED TO LOCATE AND RETRIEVE THE SPONGE. PATIENT REQUIRE REOPERATION TO REMOVE THE RETAINED SPONGE. BLOOD TRANSFUSION NOT NECESSARY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17560341 ↗
• MalfunctionAug 23, 2022False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, DURING TESTING BY BIOMED, TWO (2) DEVICES WERE NOT DETECTING AVAILABLE SPONGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15277658 ↗
• MalfunctionAug 22, 2022False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, DURING TESTING BY BIOMED, TWO (2) DEVICES WERE NOT DETECTING AVAILABLE SPONGES. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266700 ↗
• MalfunctionAug 22, 2022False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE WAS NOT WORKING AT ALL AS IT WAS NOT RECOGNIZING THE RADIOFREQUENCY (RF) SPONGES. A NEW WAND WAS USED WITH THE SAME CONSOLE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15266580 ↗
• MalfunctionNov 15, 2021False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE WAS NOT WORKING WHEN CONNECTED. THE WAND WAS NOT DETECTING EVEN PRESENT. REPLACED WITH ANOTHER SIMILAR DEVICE AND IT WORKED FINE. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12813613 ↗
• InjuryAug 25, 2021False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, AT THE END OF THE CASE, THE DEVICE ALARMED. ALL OF COUNTS WERE CORRECT, AND ORIGINAL WANDING WAS IN NEGATIVE. THE DOCTOR WAS NOTIFIED THAT THE WANT INDICATED A DETECTED SPONGE AT THE PATIENT'S SIDE TATTOO AS WELL AS ANKLE TATTOO. CALLED FOR AN X-RAY AND IT WAS NEGATIVE. THERE WAS NO PATIENT INJURY.

  Patient problems: Unintended Radiation Exposure

  MAUDE report 12364055 ↗
• InjurySep 15, 2020False Positive Result; False Positive Result

  ACCORDING TO THE REPORTER, DURING A PROCEDURE, THE STAFF WAS PERFORMING A CLOSING COUNT, WHICH WAS CORRECT, FOLLOWED BY THE RF WAND SCAN DEVICE. THE SCAN INDICATED RETAINED SPONGE. COUNT WAS REPEATED AND THE RF WAND PRODUCED THE SAME RESULT. SURGEON ENDED UP OPENING THE INCISION SITE (ABOUT 5-6 INCHES LONG IN THE GROIN). THERE WAS NO RETAINED SPONGE. STAFF ENDED UP GETTING A NEW RF WAND HAND PIECE, REPEATED THE SCAN WHICH WAS NEGATIVE.

  Patient problems: No Code Available

  MAUDE report 10534891 ↗
• MalfunctionApr 10, 2019False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, DURING SERVICING, THE DEVICE DID NOT DETECT BUT THERE IS PRESENT. THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Patient Involvement

  MAUDE report 8500437 ↗
• MalfunctionJan 31, 2019False Negative Result; False Negative Result

  ACCORDING TO THE REPORTER, DURING THE INSERTION OF TANDEM AND OVOIDS, THE VAGINAL PACKING WAS NOT DETECTED BY THE WAND, BUT IT WAS PRESENT. THE TEAM KNEW THAT THE VAGINAL PACKING WAS INTENTIONALLY RETAINED AND SCANNED THE PATIENT WITH THE WAND AND STILL NO DETECTION MADE. PATIENT LEFT THE OR AND WENT TO RADIOLOGY. PACKING WAS LATER REMOVED. THERE WAS NO PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8294833 ↗