Snowden-Pencer 89-6112Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10885403122835), received between Nov 18, 2020 and Aug 22, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (6 reports).

1 other recall cover devices cleared under the same FDA submission (K092684); they may or may not involve this specific model.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 22, 2025Mechanical Problem; Mechanical Problem

  THE USER FACILITY REPORTED VIA MEDWATCH (B)(4)THAT DURING SURGERY, THE LIVER RETRACTOR DID NOT STRAIGHTEN OUT COMPLETELY UPON REMOVAL AND ABRADED THE LEFT LOBE OF THE LIVER CREATING SOME DISCHARGE. SURGICAL POWDER AND A HEMOSTATIC AGENT WERE USED; THE SURGEON WAS ABLE TO GAIN HEMOSTASIS. THE INSTRUMENT WAS TAGGED AND SENT TO CSP AND DID NOT FIND ANY MALFUNCTION. THE USER FACILITY STATED THE PATIENT DID NOT SUFFER ONGOING ISSUES AND DID NOT REQUIRE AN EXTENDED STAY.

  Patient problems: Abrasion

  MAUDE report 22874517 ↗
• MalfunctionJan 31, 2025Break; Break

  THE USER FACILITY REPORTED VIA USER FACILITY MEDWATCH REPORT (MW5163614) THAT DURING A PATIENT PROCEDURE THEIR SNOWDEN-PENCER MIS DIAMOND-FLEX TRIANGULAR RETRACTOR BROKE, AND METAL PIECES FELL INTO THE PATIENT. ALL PIECES WERE SUCCESSFULLY RETRIEVED; THIS WAS CONFIRMED VIA X-RAY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21285339 ↗
• MalfunctionOct 23, 2024Break; Break

  THE USER FACILITY REPORTED DURING A PATIENT PROCEDURE THAT THE METAL CABLE BROKE OFF THEIR DIAMOND-FLEX TRIANGULAR RETRACTOR CAUSING SMALL SEGMENTS TO FALL INTO THE PATIENT. THE SURGEON REMOVED ALL THE PIECES, AND AN X-RAY WAS TAKEN OF THE PATIENT THAT CONFIRMED NO PIECES WERE PRESENT. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20516400 ↗
• MalfunctionJun 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED THAT DURING A PATIENT PROCEDURE, THERE WAS A TEAR IN THE ROPE WITHIN THEIR DIAMOND-FLEX TRIANGULAR RETRACTOR SUBSEQUENTLY CAUSING THE DEVICE TO SEPARATE. ALL PIECES WERE SUCCESSFULLY RETRIEVED. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19471906 ↗
• MalfunctionMar 22, 2024Insufficient Device Problem Information; Activation Problem; Insufficient Device Problem Information; Activation Problem

  THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4) THAT, "WIRE WAS NOTICED TO BE FRAYED AND THE INSTRUMENT WAS REMOVED FROM THE INSIDE OF THE PATIENT." NO REPORT OF INJURY.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961687 ↗
• MalfunctionJan 6, 2024Insufficient Device Problem Information; Insufficient Device Problem Information

  THE USER FACILITY REPORTED VIA MEDWATCH # (B)(4), THAT DURING A PATIENT PROCEDURE "MULTI PIECE DEVICE WITH TENSION WIRE TO CREATE A RIGID RETRACTOR WHEN TENSION APPLIES TO INTERNAL WIRE. THE WIRE FAILED AND PIECES OF THE DEVICE FELL INTO THE ABDOMEN. THE FAILURE WAS WITNESSED THROUGH THE LAPAROSCOPE." USER FACILITY PERSONNEL WERE ABLE TO RETRIEVE ALL PIECES AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO REPORT OF INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18461119 ↗
• MalfunctionSep 19, 2023Break; Break

  CUSTOMER SAID OR CALLED AND SAID THE DEVICE BROKE DURING SURGERY AND ONE OF THE METAL FIBERS ALMOST TORE THE LIVER. NO FURTHER INFORMATION IS NOT AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17772376 ↗
• MalfunctionNov 2, 2021Break; Break

  THE RETRACTOR SNAPPED OPEN DURING USE. WIRES WERE VISIBLE BUT NO INJURY OR IMPACT TO THE PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12739501 ↗
• MalfunctionFeb 17, 2021Break

  IT WAS REPORTED THAT THE RETRACTOR BROKE INTO MULTIPLE PIECES DURING A THORACIC ROBOTIC PROCEDURE. ALL OF THE PIECES WERE SUCCESSFULLY REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 11338537 ↗
• MalfunctionDec 8, 2020Break; Break

  IT WAS REPORTED THAT RETRACTOR CABLE BROKE DURING PROCEDURE WHILE INSIDE PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 10968748 ↗
• MalfunctionNov 18, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT THE DEVICE FAILED TO HOLD THE LIVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10862578 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092684. One submission often covers many models, so check the product and lot details in each record.

• Z-2212-2016 · Jul 1, 2016 · Terminated
  DIAMOND-FLEX CIRCULAR RETRACTOR, ANGLED, 40MM 5MM, Product Code 89-6114, Lot Code(s): 878971; 879366; 879404, and Date Code: C16. Designed to retract or elevate organs and tissue