Snowden-Pencer SP8385Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10885403224928), received between Jul 20, 2022 and Apr 10, 2026 — classified as 2 malfunctions.

The most frequently reported specific device problem is “Break” (1 report).

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 18, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 10, 2026Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TIP OF THE SNOWDEN-PENCER WAVY GRASPER FELL INTO THE PATIENT. THE TIP WAS RETRIEVED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THE PATIENT RECEIVED AN X-RAY AND CONFIRMED NO INSTRUMENT PIECES WERE PRESENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24840455 ↗
• MalfunctionJul 20, 2022Break; Break

  LAPAROSCOPIC INSTRUMENT BROKE DURING SURGICAL PROCEDURE. PICTURES WILL BE PROVIDED TO BETTER HIGHLIGHT, BUT APPEARS TO HAVE HAPPENED AT THE JAW OPEN/CLOSE MECHANISM AT THE BASE OF THE JAW AND THE DISTAL END OF THE SHAFT. UNKNOWN AT THIS TIME. BROKEN PIECES WERE RECOVERED, BUT UNSURE IF ALL PIECES WERE RETRIEVED, AS THEY MAY HAVE BEEN TOO SMALL TO DETECT. CUSTOMER MENTIONED THAT THEY DID NOT WASH IN THE INSTRUMENT, BECAUSE THEY WERE AFRAID MORE PARTS WOULD BE LOST. 07JUL2022 ADDITIONAL INFORMATION. WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? LAP CHOLE. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT¿S BODY, AND IF SO HOW WAS IT RETRIEVED? YES. BROKEN PART MAY HAVE BEEN SUCTIONED OUT, BUT COULD NOT VERIFY. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT¿S BODY, SUCH AS AN X-RAY? YES, AN X-RAY WAS PERFORMED, BUT MAY NOT HAVE BEEN DETECTABLE DUE TO SMALL SIZE. WHAT WAS THE PATIENT¿S OUTCOME? ALL INDICATIONS OF A GOOD OUTCOME. WAS THE PROCEDURE COMPLETED AS PLANNED? YES. WHAT EXACTLY IS BROKEN? APPEARS TO BE PORTION OF THE INSERT WHERE IT MEETS THE JAW. POSSIBLE INTERNAL COMPONENT OF JAW THAT ALLOWS FOR OPENING/CLOSING. CAN YOU PLEASE PROVID

  Patient problems: Foreign Body In Patient

  MAUDE report 15066710 ↗