CAIMAN PL720SURecalls & reported problems
Aesculap AG · Caiman Vessel Sealing Instrument, (360 mm), diam. 5 mm, (26,50 mm), sterile, disposable, package of 6 pieces · Class 2
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 04046964093784), received between Apr 26, 2017 and Jul 14, 2021 — classified as 1 injury, 2 malfunctions.
The most frequently reported specific device problem is “Break” (1 report).
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
- Break1
- Failure to Sense1
- Firing Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions3
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryJul 14, 2021Failure to Sense; Failure to Sense
IT WAS REPORTED TO AESCULAP AG THAT A CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM (PART # PL720SU) WAS USED DURING A PROCEDURE PERFORMED ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, AFTER THE PHYSICIAN TURNED ON THE GENERATOR AND CONNECTED THE DEVICE, THE CLAMP FAILED TO SEAL THE TISSUE. REPORTEDLY, A GENERATOR ERROR OCCURRED IN A WAY THAT RESEMBLED METAL IN THE JAW OR THE JAWS BEING OPENED. THE PHYSICIAN DISCONNECTED THE CLAMP AND TURNED OFF THE GENERATOR, AND THEN RESTARTED THE UNIT, BUT THE ISSUE RECURRED. THE PROCEDURE WAS ABLE TO BE CONTINUED AND SUCCESSFULLY COMPLETED USING ANOTHER OF THE SAME DEVICE. THE CLAMP USED IN THE SEQUENCE HAD NO ISSUES. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. AN ADDITIONAL MEDICAL INTERVENTION WAS NECESSARY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT IS FILED UNDER AAG REFERENCE CC (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 12165736 ↗MalfunctionJun 2, 2021Break; Break
IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL720SU - CAIMAN DISP.INSTR.NON ARTICUL.D:5/360MM. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE TOOK TIME TO SEAL THE VESSELS. REPORTEDLY, THERE WAS NO HEMOSTASIS. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THE EVENT. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11924908 ↗MalfunctionApr 26, 2017Firing Problem; Firing Problem
DEVICE STOPPED CAUTERIZING DURING LAPAROSCOPIC COLECTOMY. DELAY IN SURGERY AS A RESULT: 2 MINUTE DELAY. GENERATOR FUNCTIONED AS INTENDED. INSTRUMENT STOPPED SEALING AFTER SIX TO TEN SUCCESSFUL SEALS. DEVICE WAS BEING USED TO SEAL OMENTUM. TISSUE WAS SEALED WITH FULL JAW. VESSEL WAS CLAMPED PERPENDICULAR (90°). INSTRUMENT HAD NOT REQUIRED CLEANING. NO NOTABLE BLOOD LOSS. SURGERY WAS COMPLETED WITH ANOTHER CAIMAN DEVICE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 6524719 ↗
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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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