AESCULAP PL771SURecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04046964837340), received between Dec 3, 2020 and Nov 16, 2021 — classified as 1 injury, 3 malfunctions.

The most frequently reported specific device problem is “Insufficient Heating” (2 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Mar 21, 2023Open, Classified

   Potential for the spring to become loose and fall out of the device, if the spring falls out during a surgical procedure, it may enter the patient's body.

   Z-1569-2023 · Root cause: Device Design · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryNov 16, 2021Unstable; Unstable

  IT WAS REPORTED TO AESCULAP AG THAT A CAIMAN MARYLAND ARTICULATING D5/360MM (PART # PL771SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE SURGERY, THE PATIENT VESSEL BLEED. THE COMPLAINT DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. PATIENT WAS REPORTED AS DOING WELL. NO NEED FOR OPEN SURGERY. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN MADE AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: Intra-Abdominal Hemorrhage

  MAUDE report 12820619 ↗
• MalfunctionApr 26, 2021Electrical /Electronic Property Problem; Electrical /Electronic Property Problem

  IT WAS REPORTED TO AESCULAP AG THAT A CAIMAN MARYLAND ARTICULATING D5/360MM (PART # PL771SU) WAS USED DURING A PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DEVICE SPARKED. THE PHYSICIAN OPENED THE JAWS TO CUT THE ENERGY, HOWEVER, THE SEALING CONTINUED FOR THREE (3) TO FOUR (4) SECONDS. THE COMPLAINT DEVICE WAS 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 11723418 ↗
• MalfunctionMar 9, 2021Insufficient Heating; Insufficient Heating

  IT WAS REPORTED THAT THERE WAS AN ISSUE WITH PL771SU - CAIMAN MARYLAND ARTICULATING D5/360MM. ACCORDING TO THE COMPLAINT DESCRIPTION, DURING THE OPERATION TWO PRODUCTS DID NOT SEAL SUFFICIENTLY. THE FAILURE OCCUR BEFORE APPLICATION. THERE WAS NO DESCRIBED PATIENT HARM. ADDITIONAL INFORMATION WAS NOT PROVIDED NOR AVAILABLE / WAS NOT AVAILABLE. THE ADVERSE EVENT / MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

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

  MAUDE report 11446463 ↗
• MalfunctionDec 3, 2020Insufficient Heating; Insufficient Heating

  IT WAS REPORTED TO AESCULAP AG THAT A CAIMAN 5, MARYLAND ARTICULATING VESSEL SEALER (PART # PL771SU) WAS USED DURING A PROCEDURE ON AN UNKNOWN DATE. ACCORDING TO THE COMPLAINANT, THE PHYSICIAN CLAIMED THAT THE DEVICE FAILED TO SEAL SUFFCIENTLY, AND THAT THE BLEED CONTINUED. THIS MALFUNCTION PROLONGED THE SURGERY FOR LESS THAN 15 MINUTES. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. THE MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10938743 ↗