Neff G10797Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 00827002107977), received between Oct 3, 2017 and Sep 5, 2024 — classified as 4 injuries, 6 malfunctions.

The most frequently reported specific device problem is “Material Separation” (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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2024Material Separation; Material Separation

  ADDITIONAL INFORMATION WAS PROVIDED 22OCT2024. THE TIP OF THE WIRE GUIDE WILL REMAIN IN THE PATIENT. THERE ARE NO PLANS TO REMOVE THE WIRE GUIDE FRAGMENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 20152834 ↗
• InjuryMar 18, 2024Material Separation; Unraveled Material; Material Separation; Unraveled Material

  ADDITIONAL INFORMATION WAS PROVIDED ON 11APR2024. THE WIRE GUIDE WAS WITHDRAWN AND MANIPULATED THROUGH THE NEEDLE. THE CUSTOMER REPORTED THAT IT WAS POSSIBLE THE PATIENT HAD TORTUOUS ANATOMY DUE TO THE OPERATOR FOLLOWING AN OLD TRACK THAT ALREADY MIGHT HAD BEEN HEALED.

  Patient problems: Foreign Body In Patient

  MAUDE report 18924684 ↗
• MalfunctionApr 27, 2023Material Separation; Unraveled Material; Material Separation; Unraveled Material

  PER PRELIMINARY DEVICE FAILURE ANALYSIS OF THE RETURNED COMPLAINT DEVICE ON 08MAY2023, THE WIRE GUIDE WAS CONFIRMED TO BE STRETCHED AND ELONGATED. ADDITIONALLY, THE MANDRILL (INNER WIRE) OF THE WIRE GUIDE WAS NOTED TO BE SEPARATED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16825960 ↗
• InjuryAug 7, 2020Material Separation; Unraveled Material; Material Separation; Unraveled Material

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

  Patient problems: Foreign Body In Patient

  MAUDE report 10378710 ↗
• MalfunctionDec 17, 2018Material Separation; Material Separation

  IT WAS REPORTED A NEFF PERCUTANEOUS ACCESS SET WAS SELECTED FOR AN UNSPECIFIED PROCEDURE. AFTER USE, AN ATTEMPT WAS MADE TO REMOVE THE WIRE GUIDE BUT THE WIRE GUIDE HAD REPORTEDLY "MADE A LOOP" AND SEPARATED. IN ANOTHER ATTEMPT TO REMOVE THE WIRE GUIDE, THE NEEDLE WAS FIRST REMOVED AND THEN THE GUIDE WAS REMOVED WITH FORCEPS. DETAILS CLARIFYING THE EVENT AND DEVICE DAMAGE HAVE BEEN REQUESTED BUT ARE CURRENTLY UNAVAILABLE. THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS OR REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8171423 ↗
• MalfunctionMar 9, 2018Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) IN WHICH SEVERAL NEFF PERCUTANEOUS ACCESS SETS WERE EMPLOYED, THE OPERATOR OF THE DEVICES WAS REPORTEDLY HAVING TROUBLE WITH THE WIRES THAT WERE PROVIDED IN THE SETS. THE WIRES APPEARED TO BECOME STUCK IN THE INTRODUCER NEEDLES, AND IN AT LEAST ONE CASE, THE WIRE SHEARED COMPLETELY. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THE PRODUCT PROBLEMS, AND NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. ADDITIONALLY, NO PART OF THE DEFECTIVE DEVICES REMAINED IN THE PATIENT. A DEVICE WAS KEPT FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. THE CUSTOMER DID NOT REPORT WHICH OF THE FOUR REPORTED WIRES ENDED UP SHEARING. ADDITIONAL INFORMATION REGARDING THE COMPLAINT HAS BEEN REQUESTED, BUT NO ANSWERS HAVE YET BEEN PROVIDED. THIS REPORT CAPTURES ONE OF FOUR DEVICES WHICH WERE EMPLOYED IN THE SAME PROCEDURE AND WITH THE SAME PATIENT. FOR THE OTHER THREE REPORTS, PLEASE REFERENCE: MANUFACTURER REPORT # 1820334-2018-00647, MANUFACTURER REPORT # 1820334-2018-00648, MANUFACTURER REPORT # 1820334-2018-00649.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7327785 ↗
• MalfunctionMar 9, 2018Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) IN WHICH SEVERAL NEFF PERCUTANEOUS ACCESS SETS WERE EMPLOYED, THE OPERATOR OF THE DEVICES WAS REPORTEDLY HAVING TROUBLE WITH THE WIRES THAT WERE PROVIDED IN THE SETS. THE WIRES APPEARED TO BECOME STUCK IN THE INTRODUCER NEEDLES, AND IN AT LEAST ONE CASE, THE WIRE SHEARED COMPLETELY. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THE PRODUCT PROBLEMS, AND NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. ADDITIONALLY, NO PART OF THE DEFECTIVE DEVICES REMAINED IN THE PATIENT. THE DEVICE WAS KEPT FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. THE CUSTOMER DID NOT REPORT WHICH OF THE FOUR REPORTED WIRES ENDED UP SHEARING. ADDITIONAL INFORMATION REGARDING THE COMPLAINT HAS BEEN REQUESTED, BUT NO ANSWERS HAVE YET BEEN PROVIDED. THIS REPORT CAPTURES ONE OF FOUR DEVICES WHICH WERE EMPLOYED IN THE SAME PROCEDURE AND WITH THE SAME PATIENT. FOR THE OTHER THREE REPORTS, PLEASE REFERENCE: MANUFACTURER REPORT # 1820334-2018-00647, MANUFACTURER REPORT # 1820334-2018-00648, MANUFACTURER REPORT # 1820334-2018-00650.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7327740 ↗
• MalfunctionMar 9, 2018Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) IN WHICH SEVERAL NEFF PERCUTANEOUS ACCESS SETS WERE EMPLOYED, THE OPERATOR OF THE DEVICES WAS REPORTEDLY HAVING TROUBLE WITH THE WIRES THAT WERE PROVIDED IN THE SETS. THE WIRES APPEARED TO BECOME STUCK IN THE INTRODUCER NEEDLES, AND IN AT LEAST ONE CASE, THE WIRE SHEARED COMPLETELY. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THE PRODUCT PROBLEMS, AND NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. ADDITIONALLY, NO PART OF THE DEFECTIVE DEVICES REMAINED IN THE PATIENT. THE A DEVICE WAS KEPT FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. THE CUSTOMER DID NOT REPORT WHICH OF THE FOUR REPORTED WIRES ENDED UP SHEARING. ADDITIONAL INFORMATION REGARDING THE COMPLAINT HAS BEEN REQUESTED, BUT NO ANSWERS HAVE YET BEEN PROVIDED. THIS REPORT CAPTURES ONE OF FOUR DEVICES WHICH WERE EMPLOYED IN THE SAME PROCEDURE AND WITH THE SAME PATIENT. FOR THE OTHER THREE REPORTS, PLEASE REFERENCE: MANUFACTURER REPORT # 1820334-2018-00647, MANUFACTURER REPORT # 1820334-2018-00649, MANUFACTURER REPORT # 1820334-2018-00650.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7327713 ↗
• MalfunctionMar 9, 2018Difficult to Remove; Difficult to Remove

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING A PERCUTANEOUS TRANSHEPATIC CHOLANGIOGRAPHY (PTC) IN WHICH SEVERAL NEFF PERCUTANEOUS ACCESS SETS WERE EMPLOYED, THE OPERATOR OF THE DEVICES WAS REPORTEDLY HAVING TROUBLE WITH THE WIRES THAT WERE PROVIDED IN THE SETS. THE WIRES APPEARED TO BECOME STUCK IN THE INTRODUCER NEEDLES, AND IN AT LEAST ONE CASE, THE WIRE SHEARED COMPLETELY. THE CUSTOMER CONFIRMED THAT NO ADDITIONAL PROCEDURES WERE REQUIRED AS A RESULT OF THE PRODUCT PROBLEMS, AND NO PATIENT ADVERSE EVENTS RESULTED FROM THE ISSUE. ADDITIONALLY, NO PART OF THE DEFECTIVE DEVICES REMAINED IN THE PATIENT. A DEVICE WAS KEPT FOR RETURN, BUT AS OF THE DATE OF THIS REPORT, NO DEVICE HAS YET BEEN RECEIVED FOR EVALUATION. THE CUSTOMER DID NOT REPORT WHICH OF THE FOUR REPORTED WIRES ENDED UP SHEARING. ADDITIONAL INFORMATION REGARDING THE COMPLAINT HAS BEEN REQUESTED, BUT NO ANSWERS HAVE YET BEEN PROVIDED. THIS REPORT CAPTURES ONE OF FOUR DEVICES WHICH WERE EMPLOYED IN THE SAME PROCEDURE AND WITH THE SAME PATIENT. FOR THE OTHER THREE REPORTS, PLEASE REFERENCE: MANUFACTURER REPORT # 1820334-2018-00648, MANUFACTURER REPORT # 1820334-2018-00649, MANUFACTURER REPORT # 1820334-2018-00650.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7327665 ↗
• InjuryOct 3, 2017Break; Break

  THE INTERNATIONAL CUSTOMER REPORTED THAT, DURING USE OF THE NEFF PERCUTANEOUS ACCESS SET, A WIRE GUIDE BROKE AND A PIECE OF THE GUIDE WAS LEFT IN THE PATIENT. THE WIRE GUIDE HAD BECOME STUCK ON THE TIP OF THE NEEDLE THAT IT WAS BEING USED WITH. AFTER ATTEMPTING THE PROCEDURE THREE TIMES UNSUCCESSFULLY, THE PROCEDURE WAS SUSPENDED. THE OBJECT REPORTEDLY REMAINED IN THE PATIENT'S LIVER, AND AN ADDITIONAL RADIOLOGICAL ACCESS IN ANOTHER ATTEMPT TO PERFORM BILE DRAINAGE WAS NECESSITATED. THE CIRCUMSTANCES SURROUNDING THE HANDLING AND USAGE OF THE DEVICE PRIOR TO THE ENTANGLING OF THE DEVICES WAS NOT REPORTED. THE CUSTOMER REPORTED THAT 2 OF THE 3 WIRES "FADED". CLARIFICATION REGARDING THIS STATEMENT IDENTIFIED THESE TWO WIRES WERE STRETCHED AND BENT. THE QUANTITY OF DEVICES RELATED TO THE EVENT IS BEING UPDATED TO INCLUDE THESE TWO WIRES BASED ON THE DEVICE EVALUATION (WIRES UNRAVELED). THEREFORE, PLEASE NOTE THERE ARE THREE WIRES (SAME LOT) RELATED TO THIS EVENT. THE STRETCHING / BENDING OF THE TWO ADDITIONAL WIRES WAS DETERMINED TO BE NOT REPORTABLE.

  Patient problems: Foreign Body In Patient; No Code Available

  MAUDE report 6910621 ↗