ReNew 3292Recalls & reported problems
Microline Surgical, Inc. · Modified Raptor Grasper Tip, Disposable · Class 2
All models of ReNew (45)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 4
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00811099010104), received between Jun 21, 2023 and Mar 25, 2025 — classified as 4 malfunctions.
The most frequently reported specific device problem is “Fracture” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.
Reports received per month
Most reported problems
Device problems
- Fracture3
- Break1
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.
MalfunctionMar 25, 2025Fracture; Fracture
DURING PROCEDURE FOR PATIENT, WHILE THE RESIDENT WAS USING LAPAROSCOPIC INSTRUMENT WITH MICROLINE GRASPER TIP INSIDE THE PATIENT'S BODY, ONE OF THE PIECE OF GRASPER TIP CAME OFF. RESIDENT WAS ABLE TO RETRIEVE IT. PROVIDED SCRUB NURSE WITH ANOTHER MICROLINE GRASPER TIP.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21690235 ↗MalfunctionJun 3, 2024Fracture; Fracture
DURING PROCEDURE FOR PATIENT, WHILE USING LAPAROSCOPIC INSTRUMENT WITH MICROLINE GRASPER TIP INSIDE THE PATIENT'S BODY, ONE OF THE PIECE OF GRASPER TIP CAME OFF. THE PIECE WAS REMOVED FROM THE PATIENT. THE DEVICE WILL NOT BE RETURNED TO MSI
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19449710 ↗MalfunctionJun 3, 2024Fracture; Fracture
DURING PROCEDURE FOR PATIENT, WHILE WAS USING LAPAROSCOPIC INSTRUMENT WITH MICROLINE GRASPER TIP INSIDE THE PATIENT'S BODY, ONE OF THE PIECE OF GRASPER TIP CAME OFF. THE PIECE WAS RETRIREVED. THE DEVICE WILL NOT BE SENT BACK TO MICROLINE SURGICAL.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19449210 ↗MalfunctionJun 21, 2023Break; Break
SHRINK WRAP FELL OFF OF GRASPER INTO PATIENT ABDOMEN. (RETRIEVED AND REMOVED)
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 17173102 ↗
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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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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