EchoTip G53408Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 00827002534087), received between Mar 9, 2016 and Apr 22, 2025 — classified as 8 injuries, 14 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2025Fracture; Material Twisted/Bent; Fracture; Material Twisted/Bent

  DURING LYMPH NODE PUNCTURE, THE NEEDLE BENT AND BROKE. THE BROKEN PART REMAINED STUCK IN THE PATIENT'S BRONCHIAL WALL BEFORE BEING REMOVED BY THE PRACTITIONER USING A SINGLE-USE ENDOSCOPE. TO COMPLETE THE PROCEDURE, ANOTHER NEEDLE OF THE SAME REFERENCE AND BATCH NUMBER WAS USED SUCCESSFULLY. AS PER EMAIL FROM SALES REP: 1. WILL THE COMPLAINT DEVICE BE RETURNED? CURRENTLY, TRACKWISE INDICATES ¿UNSURE.¿ : WE CONFIRM THE ABSENCE OF THE MEDICAL DEVICE FOR EXPERTISE 2. PLEASE DESCRIBE THE SIZE OF THE INTENDED TARGET SITE: THE USERS DID NOT SPECIFY WHICH LYMPH NODE THE INCIDENT WAS. 3. IF THE REPORT INVOLVES A KINK, BEND, OR BREAK IN THE NEEDLE, WHERE IS THIS LOCATED ON THE DEVICE (HANDLE END (PROXIMAL END) OR PATIENT END (DISTAL END))? N/A, HANDLE END, PATIENT END : WE DON¿T KNOW. 4. WAS GAINING ACCESS TO THE TARGET SITE DIFFICULT? N/A, YES, NO : WE DON'T KNOW BECAUSE SEVERAL LYMPH NODES TREATED, INCLUDING 1 DIFFICULT BUT THE USERS DID NOT SPECIFY WHICH LYMPH NODE THE INCIDENT WAS. 5. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? WE DON'T KNOW BECAUSE SEVERAL LYMPH NODES TREATED, INCLUDING 1 DIFFICULT BUT THE USERS DID NOT SPECIFY WHICH LYMPH NODE THE INCIDENT WAS 6. WHAT IS THE SCOPE MA

  Patient problems: Foreign Body In Patient

  MAUDE report 21883877 ↗
• InjuryNov 18, 2019Break; Break

  EBUS NEEDLE THAT HAS BEEN BROKEN IN THE PATIENT. AS PER COMPLAINT FORM: "WHEN WE ARE DOING THE SECOND PASS IN 2R, WE SEE THE NEEDLE IS BROKE."

  Patient problems: Foreign Body In Patient

  MAUDE report 9335115 ↗
• MalfunctionJan 15, 2019Break; Break

  THIS REPORT IS BEING SUBMITTED AS A CANCELLATION REPORT BASED ON REVIEW OF THE COMPLETED INVESTIGATION AND IMAGES PROVIDED. INITIAL REPORTING WAS BASED ON A CONSERVATIVE APPROACH PENDING CONFIRMATION OF FAILURE MODE. FROM THE INFORMATION PROVIDED IT SEEMS THAT THE SLIDING SHEATH ADJUSTER SEPARATED FROM HANDLE. THIS COMPLAINT HAS BEEN DETERMINED TO BE USER ERROR RELATED AS THE IFU DETAILS THAT THE NEEDLE CAN BE SEPARATED FROM THE SHEATH ADJUSTER. THE DEVICE IN QUESTION HAS A REMOVABLE SHEATH ADJUSTER TO ALLOW THE USER TO INSERT THE NEEDLE INTO THE SCOPE IN THE SAME ORIENTATION REPEATEDLY. THERE HAVE BEEN NO ADVERSE EFFECTS TO THE PATIENT REPORTED AS A RESULT OF THIS INCIDENT. THIS REPORT HAS BEEN RE-ASSESSED AND DOES NOT MEET THE REPORTING CRITERIA OF A MALFUNCTION OR SERIOUS INJURY REPORT. INITIAL REPORT DETAILS: AS REPORTED TO CUSTOMER RELATIONS, "DURING THE FIRST PUNCTURE, IN THE BACK AND FORTH MOVEMENT OF THE NEEDLE INSIDE THE LYMPH NODE, THE NEEDLE'S GAUNTLET SPLIT, LEAVING ITS DISTAL END ATTACHED TO THE ENDOSCOPE, AND IT WAS NOT POSSIBLE TO CONTINUE THE PROCEDURE WITH THE REFERRED NEEDLE. CONSERVATIVE INTERPRETATION BASED ON THE RECEIPT OF THE ABOVE DESCRIPTION THIS COULD MEAN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8247519 ↗
• InjurySep 20, 2018Break; Break

  AS REPORTED TO CUSTOMER RELATIONS, "THEY ADVANCED THE NEEDLE INSIDE OF SHEATH, THROUGH THE SCOPE, AND GOT ONE PASS FOR CYTOLOGY. PULLED IT OUT AND WENT TO MAKE ANOTHER PASS BUT NEEDLE WAS NOT GOING INTO TISSUE. THEY PULLED THE IT OUT AND ADVANCED OUTSIDE OF SCOPE BUT THERE WAS NO NEEDLE. NEEDLE WAS SITTING INSIDE TISSUE OF LUNGS. THEY WERE ABLE TO SUCTION NEEDLE AND TAKE IT OUT WITHOUT COMPLICATIONS. FINISHED THE PROCEDURE WITH A WANG ASPIRATION NEEDLE SUCCESSFULLY."

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7893067 ↗
• MalfunctionSep 13, 2018Material Deformation; Material Deformation

  AS PER CC FORM : NEEDLE WAS USED TO SAMPLE NODE 4R WHICH IS A ROUTINE NODE TO SAMPLE. NEEDLE PASSED OK ON FIRST PASS AND 30-40 PUNCTURES WERE MADE. ON SECOND PASS NEEDLE PASSES OK AND 30-40 PASSES WERE MADE. ADEQUATE TISSUE WAS RETRIEVED HOWEVER ON PASSING OF THE THIRD TIME THE DR SHOWED ME HOW THE NEEDLE HAS DEVELOPED A CURVE ALL ALONG THE SHEATH AND IS NOW CURVED / BENT OUT OF ITS ORIGINAL SHAPE. HE STRAIGHTENS THE TIP OF THE NEEDLE HIMSELF TO ALLOW HIM TO PASS IT INTO THE SCOPE IN THE ANGLE HE NEEDS. THE NEEDLE PASSES OK BUT ON RETRIEVAL THIS BEND / CURVE IS BACK. THIS IS OF EXTREME CONCERN TO DR (B)(6) WHO IS WORRIED THIS CONTINUED BENDING IF THE NEEDLE WILL RESULT IN A NEEDLE SNAPPING OFF INSIDE A NODE. HE HAS REVIEWED MEDIGLOBE NEEDLES AS AN ALTERNATIVE TO COOK NEEDLES AND THEY DO NOT BEND SO HE MAY CONSIDER MOVING TO THEM SHOULD WE BE UNABLE TO SOLVE THIS ISSUE OF COOK NEEDLES BENDING. HE EXPLAINED HE SEES IT QUITE OFTEN ESPECIALLY WITH HARDENED NODES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872276 ↗
• MalfunctionAug 16, 2018Retraction Problem; Material Deformation; Retraction Problem; Material Deformation

  ON SAMPLING STATION 7 WITH A 22G ULTRA COOK NEEDLE THEY BATTLED TO GET THE NEEDLE INTO THE NODE, THE NEEDLE WAS SO BLUNT IT DEFORMED ON ENTERING THE NODE AND WE COULD NOT REMOVE THE TROCHAR. ALL THE NEEDLE AND SCOPE NEEDED TO BE REMOVED TOGETHER. THE NEEDLE WAS DEFORMED INTO A ZIG ZAG ALONG THE DISTAL TIP. THE NEEDLE COULD NOT BE FULLY RETRACTED. THE PATIENT DID NOT HAVE ANY ADVERSE EFFECTS. ADDITIONAL INFORMATION WAS RECEIVED ON 20-JUL-2018 CONFIRMING "THE NEEDLE COULD NOT BE FULLY RETRACTED". THE ORIGINAL ASSESSMENT WAS MODIFIED BASED ON THIS INFORMATION.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 7788630 ↗
• MalfunctionAug 16, 2018Retraction Problem; Retraction Problem

  AS PER CC FORM ON SAMPLING STATION 7 WITH A 22G ULTRA COOK NEEDLE THEY BATTLED TO GET THE NEEDLE INTO THE NODE, THE NEEDLE WAS SO BLUNT IT DEFORMED ON ENTERING THE NODE AND WE COULD NOT REMOVE THE TROCHAR. ALL THE NEEDLE AND SCOPE NEEDED TO BE REMOVED TOGETHER. THE NEEDLE WAS DEFORMED INTO A ZIG ZAG ALONG THE DISTAL TIP. WE THEN SWITCHED TO A COMPETITOR NEEDLE FROM MEDIGLOBE THAT PRODUCED BEAUTIFUL SAMPLES WITH MINIMAL EFFORT AND NO NEEDLE DEFLECTION. I AM THIS CONCERNED THAT WE ARE NOT USING THE IDEAL NEEDLES AND NEED TO REVIEW OUR EQUIPMENT. ADDITIONAL INFORMATION RECEIVED 07/20/2018 - CUSTOMER CONFIRMED 'NEEDLE RETRACTION ISSUE'. EVENT IS FDA MDR REPORTABLE BASED ON THE DEVICE MALFUNCTION REPORTING PRECEDENCE FOR THIS DEVICE FAMILY FOR THE ISSUE OF ¿NON RETRACTION OF NEEDLE'.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7788629 ↗
• MalfunctionJul 27, 2018Material Deformation; Material Deformation

  AS REPORTED TO CUSTOMER RELATIONS: "AT THE TIME TO TRY TO PUNCTURE THE LESION THE NEEDLE COULD NOT TRESPASS THE TRACHEAL WALL AND TRYING TO REACH THE NODE THE NEEDLE FINALLY BROKE. THE DOCTOR CHANGED TO A MEDIGLOBE NEEDLE WHICH IS THE ONE HE USUALLY USES AND COULD SEEMINGLY PUNCTURE WITHOUT PROBLEM." ADDITIONAL INFORMATION RECEIVED CONFIRMING THAT THE NEEDLE DID NOT BREAK INSIDE THE PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7726195 ↗
• MalfunctionApr 9, 2018Kinked; Kinked

  THE TIP OF THE NEEDLE GOT KINK WHEN TRYING TO TAKE SAMPLE FROM THE SUSPECTED LESION. THE CASE WAS COMPLETED WITH THE HELP OF COOK'S ANOTHER EBUS NEEDLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7406889 ↗
• MalfunctionApr 9, 2018Kinked; Kinked

  THE TIP OF THE NEEDLE GOT KINK WHEN TRYING TO TAKE SAMPLE FROM THE SUSPECTED LESION. THE CASE WAS COMPLETED WITH THE HELP OF COOK'S ANOTHER EBUS NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7406888 ↗
• InjuryJan 31, 2018Break; Break

  THE TEST BEGINS AT 4:30 P.M., THE LESION IS LOCATED AND THE PUNCTURE IS PERFORMED; WHEN THE NEEDLE IS REMOVED, IT BREAKS LEAVING A FRAGMENT OF THE NEEDLE PUNCTURED IN THE LESION (IN THE LUNG). AT THAT TIME WE TRY TO RESCUE THE NEEDLE DIRECTLY WITH A FOREIGN BODY CLAMP BUT YOU CAN NOT, SO IT IS DECIDED TO REMOVE THE ECHO BRONCHOSCOPE AND INSERT THE RIGID BRONCHOSCOPE TO REACH THE FRAGMENT OF THE NEEDLE, FINALLY WITH THE HELP OF VENTILATION IN WITH A JET AND A FOREIGN BODY FORCEPS, THE FRAGMENT OF THE NEEDLE CAN BE EXTRACTED WITHOUT ANY CONSEQUENCES FOR THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 7231095 ↗
• MalfunctionDec 18, 2017Material Protrusion/Extrusion; Material Protrusion/Extrusion

  THIS INITIAL MDR IS BEING SUBMITTED DUE TO MODERATE OVERALL RISK RATING IN REMEDIATED DFMEA. AS INSTRUCTED BY COOK IRELAND, "UNUSED, UNOPENED DEVICE RETURNED UNDER (B)(4). CHECKED FOR FAILURE MODE: NEEDLE "ADJUSTER"-BRASS INSERT DISPLACED."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7125497 ↗
• MalfunctionNov 3, 2017Bent; Kinked; Bent; Kinked

  RISK REMEDIATED AND RE-ASSIGNED TO THIS COMPLAINT ON THE (B)(6) 2017. STYLET DID NOT GO THROUGH NEEDLE IN SECOND ATTEMPT FOR BIOPSY. "AS PER COMPLAINT FORM": AFTER FIRST SUCCESSFUL PUNCTURE STYLET COULD NOT INSERTED IN TO THE NEEDLE AGAIN FOR SECOND PASS. USED ANOTHER NEEDLE TO COMPLETE THE PROCEDURE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6999064 ↗
• MalfunctionOct 9, 2017Retraction Problem; Retraction Problem

  WHILE DOING PROCEDURE THE DOCTOR PASSED THE NEEDLE TO TAKE SAMPLE TISSUE, NEEDLE GOT BENT AT FIRST PASS. ADDITIONAL INFORMATION: NEEDLE CAN'T ABLE RETRACTED INTO SHEATH. NEEDLE FULLY RETRACTED INTO SCOPE AND TAKEN AWAY FROM PATIENT.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6928829 ↗
• MalfunctionAug 11, 2017Retraction Problem; Retraction Problem

  DISTAL END OF NEEDLE KINKED AND WAS CLIPPED OFF WITH A FORCEPS. "AS PER COMPLAINT FORM": DISTAL END OF NEEDLE KINKED AFTER PUNCTION AND WAS CLIPPED OFF WITH A FORCEPS IN ORDER TO FIT NEEDLE BACK IN SHEATH.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6787654 ↗
• InjuryJun 27, 2017Break; Break

  THE NEEDLE WAS INTRODUCED FOR THE THIRD PUNCTURE AND DURING THE PUNCTURE THE NEEDLE BROKE (WITH NO EXTRA FORCE OR SCOPE SIGNIFICANT POSITION AND ANGLE). THE PHYSICIAN TRIED TO REMOVE THE 8 MM BROKEN PART BY FORCEPS WITHOUT SUCCESS. LATER ON THE PATIENT COUGHED THE BROKEN PART AND SWALLOWED IT. THE PATIENT WENT TO GASTROSCOPY PROCEDURE BUT THEY COULD NOT FIND THE BROKEN PART.

  Patient problems: Foreign Body In Patient

  MAUDE report 6669209 ↗
• InjuryJun 1, 2017Break; Break

  THIS FOLLOW UP MDR IS BEING SUBMITTED DUE TO UPDATE IN THE INVESTIGATION. TRYING TO DO A BIOPSY IN PULMONARY NODULE LOCATED IN L4 REGION THE NEEDLE BROKE, THE REGION WAS NO CARTILAGE. THEY DID THE JAB WITH THE STYLET IN THE NEEDLE IN THE CORRECT PLACE. THEY DIDN'T REMOVE THE STYLET BEFORE JAG THE LESION. THE RESULT WAS THAT THE END OF THE NEEDLE WAS BROKEN AND THIS PART WAS LOCATED AFTER WITH A GASTROSCOPE IN THE STOMACH OF THE PATIENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 6604062 ↗
• MalfunctionMay 2, 2017Retraction Problem; Retraction Problem

  MDR IS BEING SUBMITTED BASED ON THE MALFUNCTION PRECEDENCE OF 'NON-RETRACTION OF NEEDLE'. THE EBUS NEEDLE DISTAL SIDE BECOME BENT AND ALMOST BROKE DURING THE PROCEDURE. THE NEEDLE WAS REPLACED BY OTHER ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6536373 ↗
• InjuryMay 2, 2017Break; Break

  A FOLLOW-UP MDR IS BEING SUBMITTED DUE TO THE RECEIPT OF ADDITIONAL INFORMATION. INITIAL REPORT DETAILS: DURING PUNCTION THE DISTAL TIP BROKE OFF IN THE PATIENT..

  Patient problems: Foreign Body In Patient

  MAUDE report 6536360 ↗
• MalfunctionMay 2, 2017Break; Break

  THE EBUS NEEDLE DISTAL SIDE WAS BROKEN DURING PROCEDURE (THE BROKEN PART WAS TOOK OUT). THE NEEDLE WAS REPLACED BY OTHER ONE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6536185 ↗
• MalfunctionApr 3, 2017Break; Break

  A FOLLOW-UP MDR IS BEING SUBMITTED TO INCLUDE THE DEVICE EVALUATION DETAILS. INITIAL REPORT DETAILS: WHILE PERFORMING EBUS-TBNA (3RD PASS) IN STATION 11 THE NEEDLE BENT. THE SCOPE WAS REMOVED WITH THE NEEDLE INSIDE AND IT WAS NOTICED THE NEEDLE WAS BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6453200 ↗
• InjuryMar 9, 2016Break; Break

  DURING THE PROCEDURE, THE DISTAL END OF THE NEEDLE BROKE. A SECTION OF THE DEVICE REMAINED INSIDE THE PATIENTS BODY AND THIS REQUIRED SURGICAL INTERVENTION (REPEAT EBUS GUIDED TBNA) TO REMOVE THE NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 5488462 ↗