Situate 01-0034Recalls & reported problems
Covidien LP · Delivery Console 200LD-V · Class 1
Quick summary
This is a Covidien Delivery Console, a stand that detects and counts surgical sponges and laps in the operating room. Most reports describe the console raising false detections — flagging a sponge that isn't there or missing one that is — sometimes triggering error messages or failing to connect to accessories. There are 67 reports, with 5 injuries and no deaths, and no recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 67
- Deaths reported
- 0
- Injuries reported
- 5
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 67 adverse event reports that list this exact device (DI 10884521700659), received between Jul 26, 2017 and Mar 10, 2026 — classified as 5 injuries, 62 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (61 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.
Reports received per month
Most reported problems
Device problems
- False Positive Result61
- False Negative Result10
- Device Displays Incorrect Message3
- Component Missing1
- Connection Problem1
- Defective Device1
- Material Deformation1
Patient problems
- No Clinical Signs, Symptoms or Conditions32
- No Patient Involvement13
- No Consequences Or Impact To Patient10
- No Information8
- Unintended Radiation Exposure4
- Insufficient Information2
- Device Embedded In Tissue or Plaque1
- Foreign Body In Patient1
Recent adverse event reports
The 25 most recent of 67 reports, in the reporter's own words as published by the FDA.
MalfunctionMar 10, 2026False Positive Result
IT WAS REPORTED THAT DURING TESTING, THE CONSOLE WAS DETECTING WITH NOTHING REMAINING. THERE WAS NO PATIENT INVOLVED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24555655 ↗MalfunctionNov 11, 2025False Positive Result; Connection Problem; False Positive Result; Connection Problem
IT WAS REPORTED THAT ACCESSORY WOULD NOT CONNECT TO CONSOLE AND WAS DETECTING LAPS WHEN THE COUNT IS CORRECT AND THERE ARE NO LAPS RETAINED. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23520362 ↗MalfunctionAug 7, 2025False Positive Result; False Positive Result
IT WAS REPORTED THAT DURING THE PREPARATION FOR USE; THE UNIT DETECTED A SPONGE THAT WAS NOT PRESENT. THE STAFF USED THE BACKUP AND VERIFIED THAT THERE WAS NO SPONGE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22745913 ↗MalfunctionOct 29, 2024False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, THE CONSOLE WAS DETECTING A SPONGE WHEN NONE WAS PRESENT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20559934 ↗MalfunctionSep 4, 2024False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, THE UNIT WAS GIVING ERROR CODES OF DETECTING SPONGES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20135679 ↗MalfunctionAug 21, 2024False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, THE CONSOLE HAD FALSE POSITIVES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20023468 ↗MalfunctionJul 10, 2024False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, DURING PROCEDURE, THE CONSOLE HAD FALSE POSITIVES. THE SYSTEM WAS USED AFTER FINAL COUNT. ALL 10 LAPS VISUALLY ACCOUNTED FOR. THEY SCANNED THE PATIENT AND GOT A DETECTION. LAPS WERE APPROXIMATELY 4-5 FEET FROM SCANNER. THEY ENDED UP TAKING THE SPONGES OUTSIDE OF ROOM. PATIENT WAS RESCANNED AND THEY RECEIVED A CLEAR. THE CONSOLE WAS REPLACED. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19711085 ↗MalfunctionJul 9, 2024False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CONSOLE HAD FALSE POSITIVE. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19704618 ↗MalfunctionJun 27, 2024False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, DURING A NORMAL SPONTANEOUS VAGINAL DELIVERY (NSVD) PROCEDURE, THE TWO UNITS WERE SHOWING A POSITIVE DETECTION WHEN THERE WAS NO SPONGE PRESENT. AFTER THE VAGINAL BIRTH, THE REPORTER SCANNED THE PATIENT A FEW TIMES WITH ONE UNIT AND THEN BROUGHT IN ANOTHER UNIT AS WELL, TOTALING ABOUT 5 MINUTES. IT DELAYED THE PROCESS OF FINISHING UP WITH THE PATIENT AND ALLOWING HER TO GET BACK TO HER NEWBORN BABY. THE REPORTER USED ONE CONSOLE AND VERISPHERE. WHEN THAT DID NOT WORK, THEY USED ANOTHER SYSTEM WHICH INCLUDED ANOTHER CONSOLE AND VERISPHERE. A TOTAL OF TWO CONSOLES AND TWO VERISPHERES. A MANUAL COUNT WAS DONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19629023 ↗MalfunctionJun 27, 2024False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, DURING A NORMAL SPONTANEOUS VAGINAL DELIVERY (NSVD) PROCEDURE, THE TWO UNITS WERE SHOWING A POSITIVE DETECTION WHEN THERE WAS NO SPONGE PRESENT. AFTER THE VAGINAL BIRTH, THE REPORTER SCANNED THE PATIENT A FEW TIMES WITH ONE UNIT AND THEN BROUGHT IN ANOTHER UNIT AS WELL, TOTALING ABOUT 5 MINUTES. IT DELAYED THE PROCESS OF FINISHING UP WITH THE PATIENT AND ALLOWING HER TO GET BACK TO HER NEWBORN BABY. THE REPORTER USED ONE CONSOLE AND VERISPHERE. WHEN THAT DID NOT WORK, THEY USED ANOTHER SYSTEM WHICH INCLUDED ANOTHER CONSOLE AND VERISPHERE. A TOTAL OF TWO CONSOLES AND TWO VERISPHERES. A MANUAL COUNT WAS DONE TO COMPLETE THE PROCEDURE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19628737 ↗MalfunctionSep 13, 2023False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, PRIOR TO USE, THE CONSOLE KEPT SAYING "DETECTED". THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17741184 ↗MalfunctionJul 10, 2023False Negative Result; False Negative Result
ACCORDING TO THE REPORTER, THE CONSOLE WAS GIVING A FALSE CLEAR DETECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17287947 ↗MalfunctionJul 10, 2023False Negative Result; False Negative Result
ACCORDING TO THE REPORTER, THE UNIT HAD FALSE CLEAR DETECTION. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17287829 ↗MalfunctionJul 10, 2023False Negative Result; False Negative Result
ACCORDING TO THE REPORTER, THE UNIT HAD FALSE CLEAR DETECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17287700 ↗MalfunctionMar 31, 2023False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, DURING NORMAL USE, THE UNIT SCAN REPORTED A DETECTED OBJECT BUT NO SPONGE WAS THERE. THERE WAS NO PATIENT INJURY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16659097 ↗MalfunctionMar 30, 2023False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD FALSE DETECTION. A NEW DEVICE WAS USED TO COMPLETE THE PROCEDURE.THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16645094 ↗MalfunctionMar 23, 2023False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, INTRA-OPERATIVELY, THERE WERE TWO DEVICES AND TWO CONSOLES THAT HAD DETECTION ISSUES. ONE DEVICE AND ONE CONSOLE WERE DETECTED BUT NOT THERE AND THE OTHER DEVICE AND CONSOLE WERE NOT DETECTED BUT PRESENT. BOTH SCANNERS DETECTED A SIGNAL BUT NO SPONGE WAS FOUND. SYSTEMS WERE REPLACED OUT OF PRECAUTION. THERE WAS NO RETAINED SPONGE. THERE WAS NO PATIENT INJURY.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16600316 ↗MalfunctionMar 23, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result
ACCORDING TO THE REPORTER, THERE WERE TWO DEVICES AND TWO CONSOLE HAD A DETECTION ISSUE, ONE DEVICE AND ONE CONSOLE WERE DETECTED BUT NOT THERE AND THE OTHER DEVICE AND CONSOLE WAS NOT DETECTED BUT PRESENT, BOTH SCANNERS DETECTED A SIGNAL BUT NO SPONGE WAS FOUND.
Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions
MAUDE report 16600314 ↗InjuryFeb 17, 2023False Negative Result; False Positive Result; False Negative Result; False Positive Result
ACCORDING TO THE REPORTER, AFTER THE PROCEDURE, THE UNIT NOT DETECTED BUT PRESENT. PATIENT WAS SCANNED AND GIVEN A CLEAR RESULT BUT RETURNED WITH RETAINED SPONGE.
Patient problems: Foreign Body In Patient
MAUDE report 16400535 ↗MalfunctionSep 27, 2022False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE HAD FALSE POSITIVES. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15491293 ↗MalfunctionSep 7, 2022False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE HAD DETECTION ISSUE WHEREIN IT DETECTED BUT SPONGE WAS NOT PRESENT. BABY WAS DELIVERED. AFTER VAGINAL SWEEP, THE MODEL L19KKQ WAS USED AND A DETECTION OCCURRED. THE NURSE ASKED ABOUT THE BACK TABLE AND ALL SPONGES WERE ACCOUNTED FOR. THE NURSE THEN USED MODEL L19KKQ AGAIN AND A DETECTION OCCURRED ONCE MORE. AT THAT POINT, THE PHYSICIAN DID AN ADDITIONAL VAGINAL SWEEP WITH NO SPONGE LOCATED. AGAIN, A COUNT WAS DONE, AND ALL SPONGES WERE ACCOUNTED FOR. ANOTHER DELIVERY SCANNER WAS BROUGHT IN (MODEL L19KKT) AND ONCE MORE, A DETECTION OCCURRED. THE PHYSICIAN THEN LEFT THE ROOM AND ANOTHER SCAN WAS DONE AND THIS TIME, A CLEAR SCAN WAS ACCOMPLISHED ON THE PATIENT. AFTER THE CLEAR SCAN WAS ACHIEVED, THE DIRECTOR WENT INTO THE ROOM AND SCANNED ALL WHO WAS IN THE ROOM TO LOOK FOR A POTENTIAL INTERFERENCE. SCANNED THE NURSE, PATIENT (AGAIN), AND THE HUSBAND, AFTER DOING SO, ALL PEOPLE IN THE ROOM ACHIEVED A CLEAR DETECTION AND NO INTERFERENCES OCCURRED. THE ONLY PERSON THAT WAS NOT SCANNED AT THAT TIME WAS THE PHYSICIAN. THE PHYSICIAN WAS BACK TO THE HOSPITAL AND SCANNED THE ROOM FOR INTERFERENCES THAT COULD POSSIBLY CAUSE A FALSE POSIT
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15371850 ↗MalfunctionSep 7, 2022False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, POST-OPERATIVELY, THE DEVICE HAD DETECTION ISSUE WHEREIN IT DETECTED BUT SPONGE WAS NOT PRESENT. BABY WAS DELIVERED. AFTER VAGINAL SWEEP, THE MODEL L19KKQ WAS USED AND A DETECTION OCCURRED. THE NURSE ASKED ABOUT THE BACK TABLE AND ALL SPONGES WERE ACCOUNTED FOR. THE NURSE THEN USED MODEL L19KKQ AGAIN AND A DETECTION OCCURRED ONCE MORE. AT THAT POINT, THE PHYSICIAN DID AN ADDITIONAL VAGINAL SWEEP WITH NO SPONGE LOCATED. AGAIN, A COUNT WAS DONE, AND ALL SPONGES WERE ACCOUNTED FOR. ANOTHER DELIVERY SCANNER WAS BROUGHT IN (MODEL L19KKT) AND ONCE MORE, A DETECTION OCCURRED. THE PHYSICIAN THEN LEFT THE ROOM AND ANOTHER SCAN WAS DONE AND THIS TIME, A CLEAR SCAN WAS ACCOMPLISHED ON THE PATIENT. AFTER THE CLEAR SCAN WAS ACHIEVED, THE DIRECTOR WENT INTO THE ROOM AND SCANNED ALL WHO WAS IN THE ROOM TO LOOK FOR A POTENTIAL INTERFERENCE. SCANNED THE NURSE, PATIENT (AGAIN), AND THE HUSBAND, AFTER DOING SO, ALL PEOPLE IN THE ROOM ACHIEVED A "CLEAR" DETECTION AND NO INTERFERENCES OCCURRED. THE ONLY PERSON THAT WAS NOT SCANNED AT THAT TIME WAS THE PHYSICIAN. THE PHYSICIAN WAS BACK TO THE HOSPITAL AND SCANNED THE ROOM FOR INTERFERENCES THAT COULD POSSIBLY CAUSE A FALSE POS
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15371840 ↗MalfunctionMay 27, 2022False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, THE CONSOLE HAD A FALSE POSITIVE DETECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14526842 ↗MalfunctionMay 27, 2022False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, THE UNIT WAS GIVING FALSE POSITIVE DETECTION. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 14523460 ↗InjuryMay 24, 2022False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, POST-OPERATIVELY, MEDTRONIC SITUATE MACHINE SCANNED AND DETECTED SOMETHING IN PATIENT. ATTEMPTED A FEW MORE TIMES WITH THE SAME MACHINE. TROUBLESHOOTING: MOVED DELIVERY TABLE AWAY FROM BED. RECOUNTED ALL GAUZE (COUNT WAS CORRECT). OBTAINED ANOTHER SITUATE MACHINE AND RESCANNED PATIENT, ALL SCANS CAME BACK THAT SOMETHING WAS DETECTED. X-RAY WAS ORDERED FOR VERIFICATION AND TO ENSURE A SPONGE WAS NOT RETAINED INSIDE THE PATIENT. X-RAY VERIFICATION CONFIRMED ¿NO ACUTE FINDINGS¿.
Patient problems: Unintended Radiation Exposure
MAUDE report 14492347 ↗
Other Counter, sponge, surgical devices
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- Situate 01-0043RCovidien LP · Counter, sponge, surgical5 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.