Cope G48166Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00827002481664), received between Oct 24, 2018 and Jan 15, 2020 — classified as 7 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryJan 15, 2020Material Separation; Material Separation

  AS REPORTED, AN UNKNOWN PATIENT REQUIRED THE PLACEMENT OF AN ULTRATHANE COPE NEPHROURETERECTOMY SET FOR AN UNKNOWN PROCEDURE ON (B)(6) 2020. IT WAS REPORTED THAT SOMETIME BETWEEN (B)(6) 2020, THE "HUB BROKE." THE OPERATOR REPORTED THAT ON (B)(6) 2020 THE DEVICE WAS REPLACED WITH ANOTHER SIMILAR DEVICE SUCCESSFULLY. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT.

  Patient problems: No Code Available

  MAUDE report 9592687 ↗
• MalfunctionAug 26, 2019Leak/Splash; Leak/Splash

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8932494 ↗
• InjuryAug 26, 2019Leak/Splash; Leak/Splash

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETEROSTOMY SET WAS USED FOR A NEPHROSTOMY PROCEDURE IN AN UNKNOWN PATIENT. ON (B)(6) 2019, AN UNSPECIFIED AMOUNT OF TIME AFTER PLACEMENT, THE DEVICE WAS FOUND LEAKING "WHERE THE DRAIN CONNECTS TO THE HUB" AND WAS REPLACED WITH ANOTHER OF THE SAME DEVICE. THE REPLACEMENT DEVICE WAS ALSO FOUND LEAKING UPON PLACEMENT. DERMABOND WAS USED TO GLUE THE CONNECTION TO STOP THE LEAK. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THE FIRST INSTANCE OF LEAKAGE IS CAPTURED UNDER THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6). THE LEAKAGE OF THE REPLACEMENT DEVICE IS CAPTURED UNDER THE MEDWATCH REPORT WITH PATIENT IDENTIFIER (B)(6).

  Patient problems: No Code Available

  MAUDE report 8932479 ↗
• MalfunctionJan 23, 2019Fluid/Blood Leak; Fluid/Blood Leak

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Patient Involvement

  MAUDE report 8271304 ↗
• InjuryDec 6, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THE PATIENT HAD AN ULTRATHANE COPE NEPHROURETERECTOMY STENT PLACED IN THE KIDNEY TO DRAIN URINE. THIRTEEN DAYS LATER, THE DRAIN WAS EXCHANGED DUE TO LEAKING AT THE HUB OF THE CATHETER. THIS EXCHANGE IS RECORDED UNDER MEDWATCH REPORT #1820334-2018-03341. THE REPLACEMENT DRAIN WAS ALSO FOUND TO BE LEAKING AT THE HUB AND WAS EXCHANGED 27 DAYS LATER. THIS SECOND EXCHANGE IS RECORDED IN THIS MEDWATCH REPORT (1820334-2018-03549). AS REPORTED, THE PATIENT DID NOT EXPERIENCE ANY OTHER ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Code Available

  MAUDE report 8138391 ↗
• InjuryNov 8, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WAS PLACED IN A PATIENT DURING THE "SUMMER" OF 2018. AN UNSPECIFIED AMOUNT OF TIME AFTER PLACEMENT, THE CATHETER WAS FOUND TO BE LEAKING AT THE CONNECTION BETWEEN THE CATHETER AND THE HUB. IT IS UNKNOWN IF THE CATHETER WAS REPLACED. ADDITIONAL INFORMATION REGARDING THE EVENT, PATIENT DEMOGRAPHICS, AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available; No Information

  MAUDE report 8052593 ↗
• InjuryNov 8, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WAS PLACED IN A PATIENT DURING THE "SUMMER" OF 2018. AN UNSPECIFIED AMOUNT OF TIME AFTER PLACEMENT, THE CATHETER WAS FOUND TO BE LEAKING AT THE CONNECTION BETWEEN THE CATHETER AND THE HUB. IT IS UNKNOWN IF THE CATHETER WAS REPLACED. ADDITIONAL INFORMATION REGARDING THE EVENT, PATIENT DEMOGRAPHICS, AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available; No Information

  MAUDE report 8052535 ↗
• InjuryNov 8, 2018Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETERECTOMY STENT WAS PLACED IN A PATIENT DURING THE "SUMMER" OF 2018. AN UNSPECIFIED AMOUNT OF TIME AFTER PLACEMENT, THE CATHETER WAS FOUND TO BE LEAKING AT THE CONNECTION BETWEEN THE CATHETER AND THE HUB. IT IS UNKNOWN IF THE CATHETER WAS REPLACED. ADDITIONAL INFORMATION REGARDING THE EVENT, PATIENT DEMOGRAPHICS, AND PATIENT OUTCOME HAS BEEN REQUESTED BUT IS CURRENTLY UNAVAILABLE.

  Patient problems: No Code Available; No Information

  MAUDE report 8052500 ↗
• InjuryOct 24, 2018Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED AN ULTRATHANE COPE NEPHROURETEROSTOMY STENT WAS SELECTED FOR A DRAIN EXCHANGE. ONE DAY AFTER THE EXCHANGE, THE PATIENT RETURNED DUE TO THE HUB SEPARATING FROM THE CATHETER. THE DRAIN WAS REPLACED AS A RESULT OF THIS EVENT. NO OTHER ADVERSE EFFECTS WERE REPORTED FOR THIS INCIDENT. THE EXACT DATE OF EVENT IS UNKNOWN BUT THE CUSTOMER REPORTED THE EVENT OCCURRED WITHIN THE PAST WEEK OR SO FROM THE MANUFACTURER'S AWARE DATE.

  Patient problems: No Code Available

  MAUDE report 8000658 ↗