N/A 8360-00Recalls & reported problems
Smith & Nephew, Inc. · GRSPR ATRMTC S/A 5MM X 36CM · Class 1
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885554017113), received between Oct 10, 2024 and Sep 11, 2026 — classified as 3 injuries, 1 malfunction.
The most frequently reported specific device problem is “Break” (2 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.
Reports received per month
Most reported problems
Device problems
- Break2
- Material Fragmentation2
Patient problems
- No Clinical Signs, Symptoms or Conditions4
Recent adverse event reports
The 4 most recent of 4 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 GRASPERSGL-ACT5MM 36CM (Part # 8360-00) 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 50737761 ↗InjurySep 11, 2026Material Fragmentation
It was reported to Aesculap Inc. that a PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM (Part # 8360-00) was used during a hysterectomy procedure an unspecified date. 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 50737757 ↗MalfunctionApr 7, 2026Break
ACCORDING TO THE EVENT DESCRIPTION: THE JAWS BROKE IN THE PATIENT SO THEY HAD TO RETRIEVE THE BROKEN PIECE AND ALSO X-RAY THE PATIENT TO ENSURE THEY DID IN FACT GET EVERYTHING.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24800308 ↗InjuryOct 10, 2024Break; Break
IT WAS REPORTED TO AESCULAP INC. THAT A PRESTIGE ATRA GRASPERSGL-ACT5MM 36CM (PART# 8360-00) WAS USED DURING A ENDOSCOPIC PROCEDURE ON (B)(6) 2024. ACCORDING TO THE COMPLAINANT THE MOVEABLE PART OF THE GRASPER BROKE INSIDE THE PATIENT. THE PART WAS RETRIEVED AND IMMEDIATELY DISCARDED. REPORTEDLY AND MRI WAS PERFORMED IN ORDER TO ENSURE NO FRAGMENTS REMAINED INSIDE THE PATIENT. THE ADVERSE EVENT IS FILED UNDER AIC REFERENCE XC 100037234 CC 400678199.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20416369 ↗
Other ACCESSORIES,ARTHROSCOPIC devices
- Arthrex® AR-12990Arthrex, Inc. · Accessories, arthroscopic409 reports
- NA 228302Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC287 reports
- FIRSTPASS 72290128Smith & Nephew, Inc. · ACCESSORIES,ARTHROSCOPIC232 reports
- NA 251723Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC145 reports
- COBRA 3910900093Stryker Corporation · Accessories, arthroscopic138 reports
- FirstPass 72290129Smith & Nephew, Inc. · Accessories, arthroscopic82 reports
- FirstPass 72290130Smith & Nephew, Inc. · Accessories, arthroscopic80 reports
- MITEK 242025Medos International Sàrl · ACCESSORIES,ARTHROSCOPIC61 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page