N/A 8360-10Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885554016161), received between Jul 23, 2024 and Sep 11, 2026 — classified as 3 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjurySep 11, 2026Material Fragmentation

  It was reported to Aesculap Inc. that a PRESTIGE ATRA GRASPER DBL-ACT 5MM (Part # 8360-10) was used during a hysterectomy procedure sometime in (b)(6) 2026. The device broke apart during a bilateral hysterectomy, and an X-Ray was taken to ensure that no fragment remained in the surgical field.Additional information has been requested but not yet provided.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50737754 ↗
• MalfunctionJul 16, 2025Break; Break

  IT WAS REPORTED TO AESCULAP INC. THAT A PRESTIGE ATRA GRASPER DBL-ACT 5MM (PART#: 8360-10) WAS USED DURING A LAPAROSCOPIC CHOLECYSTECTOMY ON (B)(6) 2025. ACCORDING TO THE COMPLAINANT THE DOUBLE ACTION GRASPER WAS STUCK OPEN IN THE PATIENT. ONCE REMOVED FROM THE PATIENT GRASPER TIPS BROKE OFF ON THE BACK TABLE. REPORTEDLY THERE WAS A 10 MINUTE DELAY TO THE PROCEDURE. NO PATIENT COMPLICATIONS WERE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22523211 ↗
• InjuryMay 12, 2025Break; Break

  ACCORDING TO THE EVENT DESCRIPTION: A PRESTIGE ATRA GRASPER DBL-ACT 5MM (PART # 8360-10) FRACTURED CAUSING ONE OF THE JAWS AND TWO OTHER PIECES TO FALL INSIDE OF A PATIENT. THE INSTRUMENT WAS REMOVED AND INTERVENTION WAS NEEDED TO COLLECT THE PIECES AND AN XRAY WAS TAKEN TO CONFIRM ALL PIECES HAD BEEN RETRIEVED IN THE PATIENT. REPORTEDLY THERE WAS A TEN MINUTE DELAY TO THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22001924 ↗
• MalfunctionFeb 4, 2025Material Fragmentation; Material Fragmentation

  IT WAS REPORTED TO AESCULAP INC. THAT A PRESTIGE ATRA GRASPER DBL-ACT 5MM (PART # 8360-10) WAS USED DURING A LAPAROSCOPIC PROCEDURE IN APPROXIMATELY IN (B)(6) 2025. ACCORDING TO THE COMPLAINANT THE DEVICE BROKE WHILE IN USE DURING THE PROCEDURE. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4). THE COMPLAINT WAS RECEIVED VIA A MEDWATCH REPORT (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21307052 ↗
• InjuryJul 23, 2024Break; Break

  IT WAS REPORTED TO AESCULAP INC. THAT A PRESTIGE ATRA GRASPER DBL-ACT 5MM (PART # 8360-10) WAS USED DURING A LAPAROSCOPIC PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THE DEVICE BROKE DURING A PROCEDURE. THE GRASPING TEETH WERE RETRIEVED AND X-RAYS WERE DONE ON PATIENT TO SHOW NO PIECES WERE LEFT IN THE SITE. REPORTEDLY THERE WAS A DELAY OF FIFTEEN (15) MINUTES DUE TO TAKING X-RAYS. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19804780 ↗