Situate 01-0043RRecalls & reported problems
Covidien LP · Delivery Console 200X · Class 1
All models of Situate (29)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 5
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10884521705319), received between Jul 3, 2018 and Nov 10, 2020 — classified as 5 malfunctions.
The most frequently reported specific device problem is “False Positive Result” (4 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
Device problems
- False Positive Result4
- Failure to Power Up2
- False Negative Result1
- Intermittent Energy Output1
Patient problems
- No Patient Involvement3
- No Consequences Or Impact To Patient2
Recent adverse event reports
The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.
MalfunctionNov 10, 2020False Negative Result; False Negative Result
ACCORDING TO THE REPORTER, PRIOR TO USE, THE DEVICE WOULD NOT SCAN. NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 10815835 ↗MalfunctionAug 28, 2018False Positive Result; False Positive Result
ACCORDING TO THE REPORTER, THE DEVICE HAD FALSE POSITIVES. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7822402 ↗MalfunctionJul 18, 2018False Positive Result
ACCORDING TO THE REPORTER, WHILE USING THE UNIT ON THE PATIENT, IT WAS GIVING (B)(6) ERROR. THERE WAS NO PATIENT INJURY.
Patient problems: No Consequences Or Impact To Patient
MAUDE report 7698542 ↗MalfunctionJul 5, 2018False Positive Result; Failure to Power Up; False Positive Result; Failure to Power Up
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT WOULD SHUTDOWN OFTEN AND WHEN IT SCAN, IT GOT WRONG READINGS. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7664872 ↗MalfunctionJul 3, 2018False Positive Result; Failure to Power Up; Intermittent Energy Output; False Positive Result; Failure to Power Up; Intermittent Energy Output
ACCORDING TO THE REPORTER, PRIOR TO USE, THE UNIT SHUT OFTEN. IT ALSO GIVE WRONG READING WHEN THEY SCANNED IT. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Patient Involvement
MAUDE report 7659082 ↗
Other Counter, sponge, surgical devices
- SURGICOUNT 0694002090Stryker Corporation · Counter, sponge, surgical2 recalls0 reports
- Situate 01-0031Covidien LP · Counter, sponge, surgical97 reports
- Situate 01-0043Covidien LP · Counter, sponge, surgical94 reports
- Situate 01-0034Covidien LP · Counter, sponge, surgical67 reports
- Situate 01-0035Covidien LP · Counter, sponge, surgical18 reports
- Situate 01-0046Covidien LP · Counter, sponge, surgical10 reports
- N/A 0794001010Stryker Corporation · Counter, sponge, surgical7 reports
- SurgiCount 0894000005Stryker Corporation · Counter, sponge, surgical6 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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