AESCULAP PL049RRecalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04038653335695), received between Oct 4, 2022 and Oct 5, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Fracture” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryOct 5, 2022Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP INC. THAT A ATR.GRASPER DOUBLE ACTION 420MM (PART # PL049R) WAS USED DURING A GYNECOLOGIC LAPAROSCOPY PROCEDURE PERFORMED ON (B)(6) 2022. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE LAPAROSCOPIC GRASPER BROKE AND A FRAGMENT DETACHED INTO THE PATIENT. THE BROKEN PIECE WAS RETRIEVED FROM THE PATIENT, AND THEN THE PROCEDURE WAS CONTINUED WITHOUT FURTHER ISSUE. THE COMPLAINT DEVICE HAS NOT BEEN RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT INJURY WAS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15546321 ↗
• InjuryOct 4, 2022Fracture; Fracture

  IT WAS REPORTED TO AESCULAP AG THAT AN ISSUE OCCURRED WITH AN ATR.GRASPER DOUBLE ACTION 420MM (PART # PL049R) VIA INFORMATION RECEIVED FROM USER FACILITY MW (B)(4). ACCORDING TO THE COMPLAINANT, A PIECE OF THE GRASPER BROKE INSIDE THE PATIENT. THE PIECE WAS IMMEDIATELY IDENTIFIED AND REMOVED. THIS OCCURRED DURING A LAPAROSCOPIC GYNECOLOGIC SURGERY. PATIENT WAS NOT FURTHER INJURED. AN ADDITIONAL MEDICAL INTERVENTION WAS REQUIRED. THE ADVERSE EVENT /MALFUNCTION IS FILED UNDER AAG REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539133 ↗