Epix ® Laparoscopic Dissector CY010Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00607915126964), received between Feb 15, 2017 and May 12, 2026 — classified as 5 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 12, 2026Detachment of Device or Device Component

  PROCEDURE PERFORMED: TOTAL LAPARASCOPIC HYSTERECTOMY. EVENT DESCRIPTION: DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY AT THE END WHILE FINISHING, THE SURGEON WAS USING DISSECTORS AND WHEN THEY PULLED THEM OUT OF THE TROCAR, HALF OF THE JAW WAS MISSING. IMMEDIATELY X-RAYED PATIENT DURING THE SURGERY AND FOUND THE PIECE BUT WAS UNABLE TO RETRIEVE. PIECE WAS LEFT INSIDE OF PATIENT. INTERVENTION: SURGERY WAS ALREADY OVER WHEN MALFUNCTION WAS NOTICED. PATIENT STATUS: PATIENT X-RAYED, PIECE FOUND BUT NOT ABLE TO BE RETRIEVED.PATIENT X-RAYED, PIECE FOUND BUT NOT ABLE TO BE RETRIEVED.

  Patient problems: Foreign Body In Patient

  MAUDE report 25156084 ↗
• MalfunctionJan 7, 2026Fracture

  PROCEDURE PERFORMED: LAP TAPP HERNIA. EVENT DESCRIPTION: THE ACTION BEING PERFORMED WHEN THE EVENT OCCURRED WAS TRYING TO DISSECT INGUINAL REGION. WHILE DISSECTION THE INGUINAL, THE HANDLE GOT DETACHED FROM THE INSTRUMENT. LUCKILY THE SURGEON REMOVED FROM THE 5MM TROCAR HOLDING THE SHAFT END. THERE WAS NO CLINICAL IMPACT TO THE PATIENT. INTERVENTION: HE REPLACED WITH OTHER DISSECTOR FROM THE STORES. PATIENT STATUS: NOTHING ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23999160 ↗
• MalfunctionJul 12, 2021Activation Failure; Incomplete or Inadequate Connection; Activation Failure; Incomplete or Inadequate Connection

  PROCEDURE PERFORMED: UNKNOWN. EVENT DESCRIPTION: THE ACCT MGR WAS NOT PRESENT FOR THE CASE. THE CAUTERY FUNCTION DID NOT WORK FROM THE BEGINNING. IT IS UNKNOWN WHAT MONOPOLAR CORD WAS USED. A NEW DEVICE WAS OPENED AND USED TO COMPLETE THE CASE. THE CORD WAS ABLE TO BE ATTACHED TO THE DEVICE. IT IS UNKNOWN IF THE CABLE WAS REPLACED WITH THE ALTERNATE DEVICE. THERE WAS NO PATIENT INJURY. THERE ARE NO PHOTOS AVAILABLE. THE DEVICE IS AVAILABLE TO BE RETURNED. INTERVENTION: A NEW DEVICE WAS OPENED AND USE TO COMPLETE THE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12155615 ↗
• MalfunctionFeb 26, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  PROCEDURE PERFORMED: LAPAROSCOPIC CHOLECYSTECTOMY. DURING THE CASE, ONE OF THE JAWS BROKE OFF THE DISSECTOR AND FELL INTO THE PATIENT. IT IS UNKNOWN WHEN DURING THE CASE THIS OCCURRED. THE DISSECTOR WAS USED TO DISSECT THE CYSTIC DUCT. NO DAMAGE WAS NOTED ON THE DISSECTOR PRIOR TO THE JAW BREAKING. THE PIECE WAS RETRIEVED FROM THE PATIENT. THE CASE WAS COMPLETED WITH A NEW DISSECTOR. NO PATIENT INJURY. NO PHOTOS ARE AVAILABLE. PRODUCT IS AVAILABLE FOR RETURN. ADDITIONAL INFORMATION RECEIVED VIA EMAIL ON (B)(6) 2021 FROM [NAME]: THE EXACT DATE WAS NOT AVAILABLE. I WAS TOLD IT OCCURRED APPROXIMATELY 2 WEEKS PRIOR TO THE DATE I FILED THE CER. THE DISSECTOR WAS BEING USED TO DISSECT THE CYSTIC DUCT. INTERVENTION: USED NEW RETRIEVAL BAG TO COMPLETE CASE. PATIENT STATUS: NO PATIENT INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11389154 ↗
• MalfunctionFeb 15, 2017Failure To Adhere Or Bond; Failure To Adhere Or Bond

  UNKNOWN PROCEDURE - "DISSECTOR SCISSORED AT TIP." TYPE OF INTERVENTION - NA. PATIENT STATUS - "RELEASED."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6333831 ↗