n.a. 27290MRecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 04048551082508), received between Jan 9, 2020 and Jun 26, 2025 — 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.

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.

• InjuryJun 26, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE INFORMATION RECEIVED, THE GRASPER, FROM ONE OF THE PCNL SETS HAD BROKEN DURING USE. REPORTEDLY, THE INSTRUMENT WAS FUNCTIONING NORMALLY AT THE START OF THE CASE, BUT LATER THE GRASPING MECHANISM STOPPED WORKING. UPON INSPECTION, IT WAS CLEAR THE RIVET / SCREW THAT SECURED ONE SIDE OF THE JAW MECHANISM WAS MISSING. THE SCRUB TEAM HAD ENDEAVORED TO FIND THE MISSING PIECE, BUT WERE UNABLE TO DO SO, LATER ON, IN THE POUCH OF THE OPERATION DRAPE WE HAVE FOUND A METAL PIECE WHICH COULD POSSIBLE BE THE MISSING PART OF THE FORCEPS, X RAY TAKEN. SINCE ADDITIONAL X RAY TAKEN, THIS CASE IS REPORTABLE

  Patient problems: Foreign Body In Patient; Insufficient Information

  MAUDE report 22340857 ↗
• InjuryNov 3, 2023Break; Break

  IT WAS REPORTED THAT THE FORCEPS BECAME DEFECTIVE DURING THE VERY FIRST PCNL SURGERY THE FORCEPS WERE USED FOR. ONE OF THE GRASPER JAWS HAD BECOME LOOSE FROM THE JOINT AFTER ONE STONE HAS BEEN REMOVED DURING A PCNL PROCEDURE. THE GRASPING FORCEPS HAD BEEN REMOVED FROM THE SURGERY AT ONCE. IT WAS REPORTED THAT THE FORCEPS SHAFT CAME OFF DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. AS THE PIN OF THE JOINT IS MISSING THIS CASE DEEMED AS REPORTABLE AS PRECAUTIONARY ACTION.

  Patient problems: Insufficient Information

  MAUDE report 18067971 ↗
• InjuryNov 2, 2023Break; Break

  IT WAS REPORTED THAT THE FORCEPS BECAME DEFECTIVE DURING THE VERY FIRST PCNL SURGERY THE FORCEPS WERE USED FOR. ONE OF THE GRASPER JAWS HAD BECOME LOOSE FROM THE JOINT AFTER ONE STONE HAS BEEN REMOVED DURING A PCNL PROCEDURE. THE GRASPING FORCEPS HAD BEEN REMOVED FROM THE SURGERY AT ONCE. IT WAS REPORTED THAT THE FORCEPS SHAFT CAME OFF DURING A PROCEDURE. NO NEGATIVE IMPACT IN STATE OF HEALTH REPORTED. AS THE PIN OF THE JOINT IS MISSING THIS CASE DEEMED AS REPORTABLE AS PRECAUTIONARY ACTION.

  Patient problems: Insufficient Information

  MAUDE report 18060105 ↗
• MalfunctionJan 9, 2020Material Separation; Material Separation

  PER THE FACTORY IN (B)(6), ALLEGEDLY, THERE WAS AN EVENT OCCURRED IN (B)(6) DURING A PROCEDURE, A PIECE BROKE OFF AND FELL INSIDE THE PATIENT; IT IS UNCLEAR IF THE BROKEN PIECE REMAINED IN THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 9570073 ↗