Cope G05177Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00827002051775), received between Mar 14, 2016 and Feb 26, 2018 — classified as 5 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 26, 2018Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT AFTER THE INITIAL ACCESS WAS ESTABLISHED DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY PROCEDURE, WHILE MANIPULATING THE COPE STAINLESS STEEL MANDRIL WIRE GUIDE , APPROXIMATELY TWO CENTIMETERS OF THE DISTAL TIP BROKE AND COULD NOT BE RETRIEVED, DESPITE SEVERAL ATTEMPTS. THE END OF THE WIRE REMAINED INSIDE THE PATIENT AND THERE ARE NO PLANS CURRENTLY TO REMOVE THE PIECE. ADDITIONAL DETAILS REGARDING THE INCIDENT HAVE BEEN REQUESTED FROM THE CUSTOMER. THE COMPLAINT PRODUCT IS REPORTEDLY UNAVAILABLE FOR RETURN; HOWEVER, AN UNUSED DEVICE OF THE SAME LOT IS AVAILABLE. AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION.

  Patient problems: Foreign Body In Patient

  MAUDE report 7298061 ↗
• MalfunctionFeb 5, 2018Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A NEPHROSTOMY PROCEDURE, THE DISTAL TIP OF THE COPE STAINLESS STEEL MANDRIL WIRE GUIDE BROKE. THE PHYSICIAN UTILIZED A DEVICE FROM ANOTHER SUPPLIER TO COMPLETE THE PROCEDURE WITH NO ADVERSE EVENTS OR ADDITIONAL PROCEDURES NECESSITATED STATING THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT. THE DEVICE IS REPORTEDLY UNAVAILABLE FOR RETURN AND EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7242599 ↗
• InjuryAug 9, 2017Material Separation; Material Separation

  INTERNATIONAL CUSTOMER REPORTED THAT A PATIENT WAS UNDERGOING PLACEMENT OF A CATHETER FOR AN ABSCESS DRAINAGE. A COPE STAINLESS STEEL MANDRIL WIRE GUIDE WAS UTILIZED FOR THE CATHETER PLACEMENT. THE CUSTOMER STATED THAT A PORTION OF THE WIRE "CAME AWAY AND WAS STILL INSIDE THE PATIENT" WHEN THE DEVICE WAS BEING REMOVED. THE PHYSICIAN USED A SNARE KIT TO SAFELY REMOVE THE RETAINED PIECE OF WIRE FROM THE IMPLANT SITE. THE PATIENT IS REPORTED AS "FINE." THE DEVICE IS NOT AVAILABLE FOR EVALUATION.

  Patient problems: Device Embedded In Tissue or Plaque; No Code Available

  MAUDE report 6777279 ↗
• InjuryOct 31, 2016Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT A PATIENT UNDERWENT A DRAINAGE PROCEDURE. AFTER PLACING A DRAINAGE TUBE IN THE PATIENT THE USER NOTICED THAT THE TIP OF THE GUIDE HAD DETACHED DURING WITHDRAWAL. THE FLEXIBLE PART OF THE GUIDE WIRE REMAINED IN THE CAVITY TO DRAIN. A SECTION OF THE DEVICE DID REMAIN INSIDE THE PATIENT'S BODY.

  Patient problems: Device Embedded In Tissue or Plaque

  MAUDE report 6066177 ↗
• MalfunctionOct 25, 2016Break; Break

  IT WAS REPORTED THAT A PATIENT UNDERWENT A PERCUTANEOUS NEPHRECTOMY PROCEDURE. DURING THE PROCEDURE IT WAS NOTICED THAT THE TIP END OF THE CUTTING WIRE HAD BROKEN. THE PRODUCT WAS DISCARDED. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

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

  MAUDE report 6055273 ↗
• InjuryMar 23, 2016Material Separation; Material Separation

  A BI-LATERAL NEPHROSTOMY PROCEDURE WAS BEING CONDUCTED ON THE (B)(6) YEAR OLD FEMALE PATIENT WITH PRE-EXISTING CONDITION OF BI-LATERAL HYDRO-NEPHROSIS. THE PHYSICIAN WAS ATTEMPTING TO GAIN ACCESS INTO THE MAIN COLLECTION SYSTEM OF THE KIDNEY. THE CALYX PROVED AWKWARD TO NAVIGATE AND THE PHYSICIAN SAYS HE MIGHT HAVE PULLED ON THE WIRE A BIT TOO HARD. HE ADVISED THAT THE ANATOMY OF THE PATIENT WAS NOT TORTUOUS OR CALCIFIED. THE FLOPPY TIP DETACHED AND HE WITHDREW THE WIRE. HE USED A DIFFERENT 0.018 WIRE TO GAIN ACCESS AND THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT. INFORMATION WAS PROVIDED THAT THE FLOPPY TIP REMAINS WITHIN THE PATIENT'S BODY AND IT WILL BE SNARED AND REMOVED AS PART OF A PLANNED INSERTION OF A URETERIC STENT WITHIN THE NEXT TWO WEEKS. IT SHOULD BE NOTED THAT THIS SECOND PROCEDURE WOULD HAVE BEEN PLANNED EVEN IF THIS INCIDENT HAD NOT HAPPENED. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: Foreign Body In Patient

  MAUDE report 5519455 ↗
• InjuryMar 14, 2016Material Separation; Material Separation

  DURING A PANCREATIC DRAINAGE INTERVENTION, THE END OF THE GUIDE BROKE INSIDE THE PATIENT'S PANCREAS UPON WITHDRAWAL AFTER PASSING THROUGH A FINE NEEDLE. THE GUIDE PIECE REMAINED IN THE PATIENT. ACCORDING TO THE PHYSICIAN, IT WAS IMPOSSIBLE TO RETRIEVE GIVEN ITS LOCATION. ACCORDING TO THE INITIAL REPORTER, NO PROCEDURES HAVE BEEN PLANNED TO REMOVE THE SEPARATED PORTION AT THIS TIME. ADDITIONAL INFORMATION HAS BEEN REQUESTED. HOWEVER, IT WAS NOT PROVIDED AT THE TIME OF THIS REPORT.

  Patient problems: Foreign Body In Patient

  MAUDE report 5498441 ↗