Echotip Ultra G03793Recalls & reported problems

Summary

The FDA's MAUDE database contains 45 adverse event reports that list this exact device (DI 00827002037939), received between Feb 26, 2016 and Aug 21, 2025 — classified as 45 malfunctions.

The most frequently reported specific device problem is “Bent” (26 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 25 most recent of 45 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 21, 2025Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. IT WAS REPORTED THAT THE PHYSICIAN OBSERVED A LITTLE BIT OF A KINK ON THE CATHETER. THE NURSE TRIED TO MOVE FORWARD AND BACKWARD TRY TO RETRIEVE THE NEEDLE, BUT THE HANDLE SEPARATED INTO TWO (2), TOTAL DISASSEMBLY. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22860428 ↗
• MalfunctionAug 12, 2024Break; Difficult to Advance; Break; Difficult to Advance

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO PLACE FIDUCIALS. HE STUCK THE LESION AND THE NEEDLE LOOKED STRAIGHT AND WENT IN SMOOTHLY. WHEN HE UNLOCKED THE DEVICE AND STUCK THE LESION, HE STARTED TO MAKE THE INITIAL PASS. THE MOMENT HE TOOK THE HANDLE AND PUSHED IT DOWN TO MAKE THE NEEDLE GO INTO THE PATIENT, IT WENT DOWN ABOUT 2 CM AND THEN THE STYLET WAS COMING OUT THE BACK OF THE NEEDLE BY ITSELF. HE DID NOT NOTICE IT. HE TRIED TO MAKE ANOTHER AND ABOUT 2 MORE CM OF THE STYLET CAME OUT. THE PHYSICIAN PULLED THE NEEDLE BACK INTO THE SHEATH AND REMOVED IT WITH THE SCOPE. HE TRIED TO TEST THE NEEDLE OUTSIDE THE PATIENT BY PUSHING THE HANDLE DOWN TO EXPOSE THE NEEDLE AND THE NEEDLE DID NOT COME OUT OF THE SHEATH. AFTER THAT, HE PUSHED THE STYLET BACK INTO THE HANDLE AND THE NEEDLE CAME OUT OF THE SHEATH. THEY HAD TO PHYSICALLY PUSH THE NEEDLE INTO THE SHEATH SO THAT THE NEEDLE WOULD NOT BE EXPOSED WHILE RETURNING IT TO COOK FOR INVESTIGATION. THEY HAD TO ABORT THIS PORTION OF THE PROCEDURE WITHOUT PLACING ANY FIDUCIALS BECAUSE THEY DID NOT HAVE ANY MORE FIDUCIAL NEEDLES TO USE. A SECTIO

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19961908 ↗
• MalfunctionJan 31, 2023Break; Difficult to Advance; Break; Difficult to Advance

  DURING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. IT WAS REPORTED THAT THE FIDUCIALS WERE NOT COMING OUT OF THE NEEDLE. THRE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 01/10/2023 AND DURING THE INITIAL DEVICE EVALUATION, IT WAS NOTED, "THE DEVICE WAS RETURNED WITH THE STYLET BENT AND THE NEEDLE EXTENDED PARTIALLY. DURING A FUNCTION TEST HANDLE WAS MANIPULATED AND THE NEEDLE WOULD ADVANCE FURTHER HOWEVER WOULD NOT RETRACTED FULLY. THE NEEDLE IS SEPARATED INSIDE THE HANDLE (SUBJECT OF REPORT)." A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16271634 ↗
• MalfunctionDec 7, 2022Break; Difficult to Advance; Break; Difficult to Advance

  DURING EUS FIDUCIAL INSERTION, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. IT WAS REPORTED THAT THE PHYSICIAN HAD DIFFICULTY DEPLOYING THE FIDUCIALS. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED 11/16/2022. DURING EVALUATION IT WAS NOTED, "THE DEVICE RETURNED WITH THE NEEDLE ADJUSTER IN THE RETRACTED POSITION HOWEVER THE NEEDLE WAS EXPOSED. THE HANDLE WAS MANIPULATED AND NO MOVEMENT WAS NOTED FROM THE NEEDLE." THE NEEDLE WAS BROKEN AND DETACHED AT THE HANDLE END. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15932641 ↗
• MalfunctionNov 7, 2022Break; Component Missing; Difficult to Advance; Break; Component Missing; Difficult to Advance

  DURING AN UNSPECIFIED PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. IT WAS INITIALLY REPORTED THAT THERE WERE NO FIDUCIALS ON THE NEEDLE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. IT WAS DETERMINED ON 18 OCTOBER 2022 PER DEVICE EVALUATION THAT THE NEEDLE HAD THE CORRECT NUMBER (4) OF FIDUCIALS; HOWEVER, THEY WERE UNABLE TO RETRACT NEEDLE (SUBJECT OF THIS REPORT). A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15744862 ↗
• MalfunctionAug 9, 2022Device Slipped; Device Slipped

  DURING AN UNKNOWN ENDOSCOPIC PROCEDURE , THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. IT WAS REPORTED [THAT] THE NEEDLE SLIDES EVEN WHEN APPLYING THE BRAKES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15190669 ↗
• MalfunctionJul 5, 2022Break; Retraction Problem; Detachment of Device or Device Component; Difficult to Advance; Break; Difficult to Advance

  DURING FIDUCIAL PLACEMENT FOR RADIOTHERAPY, THE PHYSICIAN PREPARED TO USE AN ECHOTIP ULTRA FIDUCIAL NEEDLE. PRIOR TO USE, THE NEEDLE DID NOT COME OUT OF THE SHEATH. THE ORIGINAL EVENT WAS DETERMINED TO BE NOT REPORTABLE. THE DEVICE WAS RETURNED 06/08/2022 AND THE NEEDLE WOULD NOT RETRACT INTO THE SHEATH. IT WAS DETERMINED THE NEEDLE WAS DETACHED [SUBJECT OF THIS REPORT]. AS IT WAS DISCOVERED PRIOR TO PATIENT CONTACT, A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14918741 ↗
• MalfunctionMar 23, 2022Retraction Problem; Retraction Problem

  DURING A FIDUCIAL PLACEMENT PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. ALL 4 FIDUCIALS WERE PLACED IN A PANCREATIC MASS. THE NEEDLE DID NOT RETRACT BACK INTO THE SHEATH. IT WAS CAREFULLY REMOVED FROM THE SCOPE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13861950 ↗
• MalfunctionMar 13, 2020Break; Break

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. THE DEVICE COMPLETELY DID NOT WORK AND THE NEEDLE DID NOT EVEN COME OUT OF THE SHEATH. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED. THIS EVENT WAS NOT REPORTABLE AT THE TIME. ON (B)(6) 2020 THE DEVICE WAS EVALUATED AND IT WAS DETERMINED THE NEEDLE HAD SEPARATED FROM THE INNER CATHETER. THIS OCCURRED PRIOR TO PATIENT CONTACT; THERE WAS NO IMPACT TO THE PATIENT.

  Patient problems: No Patient Involvement

  MAUDE report 9832447 ↗
• MalfunctionDec 2, 2019Fracture; Fracture

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. THE FIDUCIAL NEEDLE WAS REMOVED FROM THE PACKAGING PER THE INSTRUCTIONS. THE SHEATH LENGTH WAS ADJUSTED. FIDUCIAL NEEDLE WAS ADVANCED DOWN OLYMPUS GF-UCT 180 ENDOSCOPE. NEEDLE WAS ATTACHED TO THE ENDOSCOPE ACCESSORY PORT. NEEDLE THUMBSCREW WAS LOOSENED TO ADVANCE NEEDLE TO DESIRED LENGTH. THUMBSCREW WAS TIGHTENED. THE PHYSICIAN ATTEMPTED TO ADVANCE NEEDLE INTO THE TARGET SITE BY ADVANCING NEEDLE HANDLE TO PRE-POSITIONED SAFETY RING. HOWEVER THE NEEDLE HANDLE ADVANCED BUT NOT THE NEEDLE. NEEDLE APPEARS TO HAVE DISCONNECTED FROM NEEDLE HANDLE AND WAS UNABLE TO ADVANCE THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9398638 ↗
• MalfunctionJul 26, 2019Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. THE PHYSICIAN WAS UNABLE TO DEPLOY THE FIDUCIAL. THE PHYSICIAN USED ANOTHER NEEDLE TO COMPLETE THE CASE SUCCESSFULLY. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS RECEIVED ON 03-JUL-2019 AND IT WAS OBSERVED THAT THE NEEDLE DID NOT RETRACT [SUBJECT OF THIS REPORT] . A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8830983 ↗
• MalfunctionFeb 25, 2019Retraction Problem; Retraction Problem

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. AFTER THE DEPLOYMENT OF THE THIRD FIDUCIAL MARKER, THE NEEDLE WAS UNABLE TO RETRACT TO POINT ZERO (0) IN LENGTH. THE FOURTH FIDUCIAL MARKER COULD NOT BE DEPLOYED AND REMAINED STUCK IN THE NEEDLE. THIS CAUSED THE DEPLOYMENT OF THREE (3) FIDUCIAL MARKERS ONLY. THE NEEDLE WAS CAUTIOUSLY REMOVED FROM THE ENDOSCOPE. OTHER THAN THE DEPLOYED FIDUCIALS, A SECTION OF THE DEVICE DID NOT REMAIN IN THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8367141 ↗
• MalfunctionAug 21, 2018Material Twisted/Bent; Material Twisted/Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED THREE COOK ECHOTIP ULTRA FIDUCIAL NEEDLES. THREE (3) OF EACH OF THE SAME LOT NUMBER WERE USED AND ALL THREE (3) WERE EXTREMELY DIFFICULT TO PUSH OR ADVANCE THE FIDUCIALS OUT THE TIP OF THE SHEATH. THE ENDOSCOPE WAS STRAIGHT, THE C-CHANNEL OR OPENING WHERE THE FIDUCIALS ARE EXPOSED WAS ON THE OUTER CURVE (THE NEEDLE WAS IN THE RIGHT ANGLE FOR THE EASIEST DEPLOYMENT OF THE FIDUCIALS). THE TUMOR WAS QUITE HARD, BUT BOTH THE PHYSICIAN AND ASSISTANT WERE PUSHING WITH A STRAIGHT ENDOSCOPE AND WITH TWO (2) OTHER TECHNIQUES. THE FIRST TECHNIQUE WAS PUSHING THE NEEDLE IN TO CREATE A SPACE, THEN PULLING THE NEEDLE BACK, THEN PUSHING THE FIDUCIALS. THE SECOND TECHNIQUE WAS PUSHING THE FIDUCIAL WHILE PULLING THE NEEDLE BACK. BOTH TECHNIQUES WERE UNSUCCESSFUL AND A FOURTH NEEDLE FROM A DIFFERENT LOT NUMBER WAS USED. ALL TECHNIQUES AND CONDITIONS ABOVE WERE USED ON THE FOURTH NEEDLE. IT WAS NOT AS DIFFICULT TO ADVANCE THE FIDUCIALS EITHER IN THE TUMOR OR ON THE MARGINS. THE PHYSICIAN WAS ABLE TO PUSH THE FIDUCIALS OUT OF THE THREE (3) NEEDLES USED EARLIER OUTSIDE OF THE ENDOSCOPE AND ALSO ONE TIME JUST PUSHING IT OUT THE TIP OF THE N

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7802368 ↗
• MalfunctionAug 20, 2018Material Twisted/Bent; Material Twisted/Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. ONCE INTRODUCED INTO THE INSTRUMENT [ENDOSCOPE] WHEN THE NEEDLE WAS EJECTED FROM ITS SHIRT [SHEATH], IT CAME OUT FOLDED [BENT]. SO, THEY USED ANOTHER FIDUCIAL NEEDLE. ALWAYS IN ACCOUNT / VISION, WHICH WORKED PERFECTLY [SIC]. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 08-AUG-2018: THE NEEDLE EXITED FROM THE SHEATH BENT AT 90 DEGREES. THE USER USED ANOTHER DEVICE TO COMPLETE THE PROCEDURE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7797900 ↗
• MalfunctionJul 24, 2018Material Deformation; Material Deformation

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE (ECHO-22-F). THE PHYSICIAN WAS UNABLE TO EXPEL FIDUCIAL FROM NEEDLE TIP INTO THE LESION. THE NEEDLE WAS REMOVED AND INSPECTED BY THE STAFF. THE NEEDLE WAS BENT AND THE FIDUCIALS INSIDE [THE NEEDLE] WERE STUCK. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH ANOTHER ECHO-22-F. THE ADDITIONAL INFORMATION PROVIDED INDICATED THAT NEEDLE WAS BENT AT THE DISTAL TIP. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7713436 ↗
• MalfunctionJun 28, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE WITH FIDUCIAL PLACEMENT, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE.THERE WAS DIFFICULTY WITH THE DEVICE NOT GOING INTO THE ENDOSCOPE. THE USER SAID IT WAS HARD TO GO INTO THE ENDOSCOPE, BUT THEY MANAGED TO GET IT IN THE ENDOSCOPE. THE FIRST THREE (3) FIDUCIALS DEPLOYED BUT THE FOURTH FIDUCIAL DID NOT. IT WAS SAID THAT "IT WAS TOO SHORT. IT DID NOT FEEL LIKE IT WAS LONG ENOUGH. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS DISASSEMBLED IN ORDER TO EXTEND THE NEEDLE ON (B)(6) 2018DURING THE DEVICE EVALUATION. IT WAS DISCOVERED THERE WAS A BEND IN THE PATIENT END OF THE NEEDLE. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7646681 ↗
• MalfunctionJun 8, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED TWO (2) COOK ECHOTIP ULTRA FIDUCIAL NEEDLES. THE SAME [THING OCCURRED] FOR BOTH DEVICES. THE FIDUCIALS WOULD NOT DEPLOY INSIDE OR OUTSIDE OF THE PATIENT. THE THIRD ONE WORKED FINE. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 03/22/2018: THE AREA REPRESENTATIVE WAS NOT AWARE OF A KINK OR BEND AT ANY PART OF THE NEEDLE. THERE WAS NO ADDITIONAL INFORMATION AT THIS TIME. THE DEVICES WERE EVALUATED ON 05/14/2018 AND IT WAS OBSERVED THERE WAS A SIGNIFICANT BEND IN BOTH NEEDLES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7581688 ↗
• MalfunctionJun 7, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) PROCEDURE WITH FIDUCIAL PLACEMENT, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. PER THE CUSTOMER, THE DEVICE CAME OUT OF PACKAGE WITH A BENT TIP [NEEDLE BENT]. THEY STILL TRIED TO USE IT TO SEE IF IT WOULD STILL WORK. THEY DID NOT HAVE MUCH SUCCESS BECAUSE IT WOULD NOT DEPLOY BUT ONE TIME [ONE FIDUCIAL].

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7579261 ↗
• MalfunctionApr 4, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. THE SCOPE WAS BENT IN AN ACUTE POSITION. [THE USER WAS] UNABLE TO DEPLOY THE FIDUCIALS. TWO (2) DEVICES WERE USED DURING THIS PROCEDURE [SEE RELATED MDR 1037905-2018-00131]. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE ADDITIONAL INFORMATION RECEIVED WITH THE COMPLAINT INFORMATION INDICATES THAT THE NEEDLE WAS BENT AT AN UNKNOWN LOCATION [SUBJECT OF THIS REPORT]. CLARIFICATION WAS RECEIVED ON 03/21/18 INDICATING THE BEND WAS AT THE PATIENT END OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7397116 ↗
• MalfunctionApr 4, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. THE ENDOSCOPE WAS BENT IN AN ACUTE POSITION. [THE USER WAS] UNABLE TO DEPLOY FIDUCIALS. TWO (2) DEVICES WERE USED DURING THIS PROCEDURE [SEE RELATED MDR 1037905-2018-00132]. A THIRD DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE ADDITIONAL INFORMATION RECEIVED WITH THE COMPLAINT INFORMATION INDICATES THAT THE NEEDLE WAS BENT AT AN UNKNOWN LOCATION [SUBJECT OF THIS REPORT]. CLARIFICATION WAS RECEIVED ON 03/21/18 INDICATING THE BEND WAS AT THE PATIENT END OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7396839 ↗
• MalfunctionMar 23, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTA FIDUCIAL NEEDLE. THE STYLET WAS BENT WHEN THE NEEDLE WAS IN THE [PACKAGE]. THE USER WENT AHEAD [AND USED THE DEVICE, AND WAS] UNABLE TO ADVANCE FIDUCIAL MARKERS DUE TO THE BENT STYLET. THE PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 02/26/2018 AND IT WAS OBSERVED THE NEEDLE HAD A SIGNIFICANT KINK IN THE PATIENT END OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7366902 ↗
• MalfunctionJan 12, 2018Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS) WITH FIDUCIAL PLACEMENT, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. THE PHYSICIAN TRIED TO ADVANCE THE NEEDLE DOWN THE ENDOSCOPE. AFTER 8 CM DOWN THE ENDOSCOPE, THE NEEDLE GOT STUCK AND WOULD NOT ADVANCE FURTHER. THEY TRIED WITH A BIGGER CATHETER AND THE NEEDLE ADVANCED JUST FINE. [THE USER] OPENED A SECOND NEEDLE AND COMPLETED THE PROCEDURE SUCCESSFULLY. THE [COMPLAINT] NEEDLE APPEARED TO BE INTACT AND WITHOUT A BEND. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED ON 12/23/17: THE FACILITY USED THE SAME ENDOSCOPE AND ADVANCED A DIFFERENT DEVICE WITH A BIGGER CATHETER TO DETERMINE IF THE SCOPE WAS THE ISSUE. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 12/20/17. IT WAS OBSERVED THAT THE NEEDLE HAD A SIGNIFICANT BEND.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7185348 ↗
• MalfunctionDec 12, 2017Bent; Bent

  DURING AN ENDOSCOPIC PROCEDURE, THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. IT WAS VERY DIFFICULT TO SEE THE NEEDLE AND PIERCE THE TUMOR. THE NEEDLE WAS BENT, AND IT WAS VERY DIFFICULT TO RELEASE THE FIDUCIALS. THE PHYSICIAN COULD ONLY RELEASE ONE FIDUCIAL BECAUSE IT WAS VERY HARD, AND THE STYLET WAS ALSO BENT. THE ADDITIONAL INFORMATION PROVIDED INDICATED THERE WAS A BEND OR KINK IN THE PATIENT END OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7108442 ↗
• MalfunctionDec 7, 2017Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. AS REPORTED TO CUSTOMER RELATIONS: "[THE USER] WAS IN POSITION TO PLACE FIDUCIALS IN THE HEAD OF PANCREAS. THE DOCTOR WENT TO PLACE [THE FIDUCIALS] AND FOUND IT REALLY HARD TO PUSH THE STYLET. HE ADJUSTED THE POSITION, AND CONTINUED TO TRY TO PUSH THE FIDUCIALS OUT AND THEY WOULD NOT GO. AT THIS POINT, THE STYLET WAS BENT. THE DEVICE WAS REMOVED AND ANOTHER DEVICE WAS USED WITH NO FURTHER ISSUES." THE ADDITIONAL INFORMATION PROVIDED INDICATES THE NEEDLE HAD A KINK OR BEND AT THE PATIENT END OF THE DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7094984 ↗
• MalfunctionNov 16, 2017Bent; Bent

  DURING AN ENDOSCOPIC ULTRASONOGRAPHY (EUS), THE PHYSICIAN USED A COOK ECHOTIP ULTRA FIDUCIAL NEEDLE. THE DOCTOR HAD TO PUSH VERY HARD, DUE TO THE HANDLE (TO RELEASE THE FIDUCIALS) KINKING. THERE WAS NO REPORTABLE INFORMATION AT THIS TIME. THE DEVICE WAS EVALUATED ON 10/23/2017 AND IT WAS OBSERVED THAT THERE WAS A SEVERE BEND IN THE DISTAL END OF THE NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7038464 ↗