NA 214602Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10886705003853), received between Aug 24, 2018 and Apr 6, 2021 — classified as 3 malfunctions.

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. 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 6, 2021Difficult to Open or Close; Difficult to Open or Close

  IT WAS REPORTED BY THE SALES REP THAT DURING A ARTHROSCOPIC SHOULDER STABILIZATION PROCEDURE ON (B)(6) 2021, IT WAS OBSERVED THAT THE MECHANISM THAT OPEN AND CLOSES THE GRASPER DEVICE WAS NOT FUNCTIONING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES OR SURGICAL DELAY REPORTED. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11623010 ↗
• MalfunctionOct 31, 2018Break; Break

  THE SALES REPRESENTATIVE REPORTED THAT DURING A SHOULDER REPAIR THAT THE CUSTOMER'S PENETRATING GRASPER 45 DEGREE LEFT, BROKE WHEN PENETRATING THE ROTATOR CUFF. THE SALES REPRESENTATIVE CONFIRMED NOTHING BROKE OFF OR FELL INSIDE THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REPRESENTATIVE REPORTED THAT THE DEVICE HAS SEEN HEAVY USE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8024870 ↗
• MalfunctionAug 24, 2018Break; Break

  IT WAS REPORTED BY THE SALES REP THAT DURING A SHOULDER REPAIR, IT WAS OBSERVED THAT THE SPRING BROKE ON HIS PENETRATING GRASPER WHEN THE SURGEON WAS USING THE DEVICE. THE SALES REP CONFIRMED NOTHING FELL INSIDE THE PATIENT. THE SURGEON COMPLETED THE PROCEDURE WITH ANOTHER LIKE DEVICE WITH NO PATIENT CONSEQUENCES OR DELAY. THE SALES REP COULD NOT PROVIDE THE LOT NUMBER BUT REPORTED THE DEVICE IS OVER 2 YEARS OLD AND HAS SEEN HEAVY USE. THERE WAS PATIENT INVOLVEMENT REPORTED. THERE WERE NO INJURIES, MEDICAL INTERVENTION OR PROLONGED HOSPITALIZATION. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7812473 ↗