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Snowden-Pencer SP8364Recalls & reported problems

Steris Corporation · CROCODILE SA ERGONOMIC MODULAR 5MM,36CM,ESU INSERT · Class 2

All models of Snowden-Pencer (62)

Data updated Oct 16, 2026 from official FDA records · Editorial policy

Adverse event reports
7
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10885403171956), received between May 8, 2023 and Sep 4, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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

Nov 2023: 1 reportsDec 2023: 0 reportsJan 2024: 0 reportsFeb 2024: 1 reportsMar 2024: 0 reportsApr 2024: 0 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 0 reportsAug 2024: 0 reportsSep 2024: 0 reportsOct 2024: 0 reportsNov 2024: 0 reportsDec 2024: 0 reportsJan 2025: 0 reportsFeb 2025: 0 reportsMar 2025: 0 reportsApr 2025: 1 reportsMay 2025: 0 reportsJun 2025: 2 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 0 reportsNov 2025: 0 reportsDec 2025: 0 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 0 reportsJun 2026: 0 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520262
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Detachment of Device or Device Component4
  • Break3
  • Insufficient Device Problem Information1

Patient problems

  • No Clinical Signs, Symptoms or Conditions5
  • Foreign Body In Patient1
  • Insufficient Information1

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 4, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE TIP OF THE CROCODILE GRASPER BROKE OFF AND FELL INTO THE PATIENT. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22965612 ↗
  • MalfunctionJun 20, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THEIR CROCODILE SA ERGONOMIC MODULAR "BROKE". NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22297513 ↗
  • MalfunctionJun 5, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE DISTAL END OF THEIR CROCODILE ERGONOMIC MODULAR "SNAPPED OFF". NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22153688 ↗
  • MalfunctionApr 3, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE THE DISTAL END OF THEIR CROCODILE SA ERGONOMIC MODULAR "SNAPPED OFF" CREATING A PROCEDURE DELAY. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21770117 ↗
  • MalfunctionFeb 15, 2024Break; Break

    THE USER FACILITY REPORTED VIA MEDWATCH REPORT MW5149633 THAT THEIR CROCODILE GRASPER BROKE DURING A LAPAROSCOPIC CHOLECYSTECTOMY. THERE WAS A REPORT OF AN INJURY BUT DID NOT DISCLOSE IF MEDICAL TREATMENT WAS SOUGHT OR ADMINISTERED. NO REPORT OF PROCEDURE DELAY.

    Patient problems: Insufficient Information

    MAUDE report 18717126 ↗
  • MalfunctionNov 30, 2023Break; Insufficient Device Problem Information; Break; Insufficient Device Problem Information

    THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE A PIECE OF THE SNOWDEN-PENCER CROCODILE GRASPER BROKE OFF AND FELL ONTO THE PATIENT. IT IS UNKNOWN IF ADDITIONAL MEDICAL INTERVENTION WAS NEEDED TO RETRIEVE THE BROKEN PIECE. NO REPORT OF INJURY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18241919 ↗
  • MalfunctionMay 8, 2023Break; Break

    IT WAS REPORTED BY THE CUSTOMER THAT BROKE TODAY IN SURGERY ON ITS FIRST USE. VERBATIM: RECEIVED A REPORT OF AN ISSUE WITH ONE OF OUR SNOWDEN PENCER INSTRUMENTS. ITEM SP8364 (CROCODILE INSERT) BROKE TODAY IN SURGERY ON ITS FIRST USE. WE HAD AN SP8364 GRASPER BREAK TODAY IN SURGERY. THE FIRST TIME USING THE SET AND THE TIP OF THE GRASPER CAME OFF INSIDE THE PATIENT. SPEAKING WITH THE TECH ALL THEY DID WAS INSERT IT AND IT FELL OFF. WE WERE ABLE TO GET IT OUT. THEY HAVE THE BROKEN ITEM IN HAND AND ARE ABLE TO PROVIDE IT FOR A FULL PHYSICAL REVIEW OF WHAT MAY HAVE HAPPENED FOR THE INSTRUMENT TO BREAK. 17APR2023 ADDITIONAL INFORMATION: WHAT WAS THE PROCEDURE THAT WAS BEING PERFORMED? LAPAROSCOPIC CHOLECYSTECTOMY. DID ANY PART THE INSTRUMENT FALL INTO THE PATIENT¿S BODY, AND IF SO HOW WAS IT RETRIEVED? TIP OF THE GRASPER CAME OFF INSIDE THE PATIENT ANOTHER GRASPER WAS USED TO PULL IT OUT. WAS THERE A MEDICAL PROCEDURE PERFORMED TO VERIFY IF THE INSTRUMENT WAS IN THE PATIENT¿S BODY, SUCH AS AN X-RAY? YES, C-ARM X-RAY. WHAT WAS THE PATIENT¿S OUTCOME? GOOD. WAS THE PROCEDURE COMPLETED AS PLANNED? YES. CAN YOU PLEASE SEND ALL PARTS OF THE INSTRUMENT FOR EVALUATION? YES PACKED AND SHIPPING M

    Patient problems: Foreign Body In Patient

    MAUDE report 16886533 ↗

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Sources and updates

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