EchoTip ProCore G34281Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 00827002342811), received between Feb 16, 2016 and Dec 5, 2025 — classified as 11 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (16 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 5, 2025Material Twisted/Bent; Material Twisted/Bent

  A COMPLETE INITIAL REPORT IS BEING SUBMITTED DUE TO COMPLETION OF INVESTIGATION ON 21 NOV 2025. THE NEEDLE DID NOT ABLE TO ADVANCE OUT FROM THE SHEATH. EBUS PRO PTB FOR HEPATITIS B 1. CAN IT BE CLARIFIED WHAT IS MEAN BY EBUS PRO PTB PROCEDURE? ANS. EBUS TBNA. 2. PLEASE DESCRIBE THE LOCATION IN THE BODY FOR THE INTENDED TARGET SITE (PANCREAS, STOMACH, LUNGS, ETC.) (IF LUNGS,WHICH LYMPH NODE WAS BEING TARGETED? E.G., 2R, 2L, 4R, AO, AR, 11RI, 11S, ETC.) ANS. LUNG, NODE 7. 3. WAS PUNCTURE OF THE TARGETED SITE DIFFICULT? ANS. YES, NEEDLE COULDN'T PUNCTURE, DR TRIED AROUND 6-7 TIMES. PREVIOUSLY HAS NO PROBLEM WITH OUR NEEDLE, NOW HE'S WORRIED TO JUST SIMPLY USE OUR NEEDLE, WORRYING THE SAME THING WOULD HAPPEN AGAIN. 4. WHAT IS THE SCOPE MANUFACTURER AND MODEL NUMBER THAT WAS USED? ANS. OLYMPUS, BF-TH1100, BF-UC180F. 5. WAS THE SCOPE RECENTLY SERVICE/REPAIRED? ANS. MAINTAINED AS USUAL. 6. WAS THE DEVICE USED IN A TORTUOUS POSITION? ANS. NO. 7. WAS THE DEVICE DAMAGED IN PACKAGING BEFORE REMOVAL? N/A, YES, NO. ANS. NO. 8. WAS THE DEVICE DAMAGED ON REMOVAL FROM PACKAGING? N/A, YES, NO. ANS. NO. 9. WAS FORCE REQUIRED TO REMOVE THE DEVICE? N/A, YES, NO. ANS. NO. 10. WHEN WAS THE ISSUE NOTED?

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23724189 ↗
• InjuryOct 29, 2025Fracture; Improper or Incorrect Procedure or Method; Fracture; Improper or Incorrect Procedure or Method

  SUPPLEMENTAL REPORT IS BEING SUBMITTED DUE TO THE COMPLETION OF THE INVESTIGATION ON 05-DEC-2025.

  Patient problems: Foreign Body In Patient

  MAUDE report 23413095 ↗
• MalfunctionSep 16, 2025Retraction Problem; Physical Resistance/Sticking; Retraction Problem; Physical Resistance/Sticking

  AS REPORTED ON AHS MDIP REPORT: "PATIENT WAS HAVING AN EBUS PROCEDURE DONE. WHEN REMOVING THE SAMPLE FROM THE NEEDLE I WAS UNABLE TO PULL THE NEEDLE BACK INTO THE SHEATH. PHYSICIAN MADE AWARE. NEW NEEDLE OPENED TO FINISH THE PROCEDURE."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23069916 ↗
• InjuryDec 9, 2019Break; Break

  THE TIP OF THE NEEDLE GOT BROKEN AT ABOUT 5MM DURING USE. IT IS NOT KNOWN IF SOME PART OF THE NEEDLE WAS LEFT IN THE PATIENT. AS PER COMPLAINT FORM: "TAKING BIOPSIES FROM LYMPH NODE AT TRACHEOBRONCHIIAL TREE (EXACT PLACE AND LYMPH NODE STATION WILL BE GIVEN LATER) THEY NOTICED THAT THE TIP OF THE NEEDLE WAS MISSING. ENDOLUMINAL TIP WAS FOUND (LENGTH OF FRAGMENT 5MM) DISTALLY FROM WHERE THEY PUNCTURED IN THE RIGHT LOWER LOBE."

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 9437457 ↗
• MalfunctionOct 24, 2019Failure to Advance; Failure to Advance

  THE SHEATH DETACHED, RETRACTED AND GOT STUCK IN THE FIBROSCOPE DURING THE PROCEDURE REQUIRING THE OPERATOR TO WITHDRAW AND REQUEST ANOTHER NEEDLE. THE PROCEDURE COULDN'T BE DONE PROPERLY AS PER COMPLAINT FORM: "PROBLEM OCCURRED OFTEN. THIS DAY IT OCCURRED WITH 2 LOT NUMBER: C1536193 & C1601595 THE SHEATH DETACHED, RETRACTED AND GOT STUCK IN T HE FIBROSCOPE DURING THE PROCEDURE REQUIRING THE OPERATOR TO WITHDRAW AND REQUEST ANOTHER NEEDLE. THE PROCEDURE COULDN'T BE DONE PROPERLY. FOR THE 1ST EBUS: INABILITY TO PULL THE NEEDLE OUT OF THE SHEATH. FOR THE SECOND EBUS: INABILITY TO REMOVE THE STYLUS FROM THE NEEDLE (B)(4)."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9231445 ↗
• InjuryJul 18, 2019Break; Break

  DURING EBUS PROCEDURE USING OUR ECHO TIP PROCORE NEEDLE ASSOCIATED TO BE AN ULTRASOUND ENDOSCOPE, ECHO TIP PROCORE NEEDLE BROKE ON MORE LESS 2 CM FROM THE DISTAL EXTREMITY AND THEN, THIS PIECE OF NEEDLE REMAINED IN THE BRONCHIAL WALL OF THE PATIENT WITHOUT CROSSING WALL. EXTRACTION OF FOREIGN BODY (MORE LESS 2 CM NEEDLE) WAS PERFORMED WITH A BIOPSY CLIP WITH SUCCESSFUL. NO COMPLICATION FOR THE PATIENT DURING THIS ADDITIONAL PROCEDURE.

  Patient problems: Foreign Body In Patient

  MAUDE report 8802997 ↗
• InjuryMay 27, 2019Break; Break

  AS REPORTED TO CUSTOMER RELATIONS: "TIP OF THE NEEDLE BROKE." DM UNSURE AT TIME OF INITIAL REPORTING HOW MUCH BROKE OFF, HOW MANY PIECES, IF ANY REMAINS IN PATIENT, AT WHAT POINT OF PROCEDURE THE BREAK OCCURRED, IF THE PATIENT HAS BEEN HARMED OR ANY OTHER DETAILS.

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

  MAUDE report 8644181 ↗
• InjuryDec 18, 2018Break; Break

  THIS FOLLOW UP REPORT IS BEING SUBMITTED BASED ON THE RECEIPT OF ADDITIONAL INFORMATION REGARDING THE POTENTIAL ROOT CAUSE OF THIS COMPLAINT. REFERENCE SECTION H.10 FOR ADDITIONAL INFORMATION. INITIAL REPORT DETAILS: DURING PROCEDURE THE TIP BROKE OFF AND COULD NOT BE RETRIEVED AS OF YET. AS PER COMPLAINT FORM: "DURING THE PROCEDURE THE NEEDLE TIP BROKE OFF AND COULD NOT BE RETRIEVED AS OF YET."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8173042 ↗
• MalfunctionAug 8, 2018Break; Material Perforation; Break; Material Perforation

  FROM THE CUSTOMER ""SHEATH" WAS LOCKED, NEEDLE ADVANCED TO OBTAIN BIOPSY. SHEATH BECAME UNLOCKED AND THE NEEDLE WAS OVER ADVANCED. POTENTIAL TO PERFORATE +/- CAUSE BLEEDING. DAMAGE TO SCOPE WAS OBSERVED, LIGHT WAS DIMINISHED. SENT OFF FOR REPAIR". THE LOCKING SCREWS ON THE "SHEATH" DID NOT LOCK AND MOVED DURING FIRST ADVANCE OF THE NEEDLE PASS. SCOPE WAS ALSO DAMAGED. PROCEDURE ABORTED AFTER NO PATIENT BLEEDING OBSERVED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7761059 ↗
• MalfunctionJul 27, 2018Material Perforation; Material Deformation; Material Perforation; Material Deformation

  THIS FOLLOW UP MDR IS BEING SUBMITTED TO CORRECT THE MDR REFERENCE NUMBER ON THE PREVIOUS FOLLOW UP. THE PREVIOUS FOLLOW UP WAS SENT WITH THE REFERENCE NUMBER 3001845648-2018-00347 HOWEVER THE CORRECT REFERENCE NUMBER IS 3001845648-2018-00346. THE NEEDLE WAS PERFORRATING THE WORKING CHANNEL OF OLYMPUS ENDOSCOPE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7725799 ↗
• MalfunctionJul 24, 2018Break; Break

  NEEDLE TIP BROKE AT APPROXIMATELY 1 CM WHILST SAMPLING A TOUGH 11R NODE. "AS PER COMPLAINT FORM": DR (B)(6) WAS USING THE EBUS-O-C DEVICE FOR THE FIRST TIME AFTER RECEIVING DEMO EQUIPMENT IN BACK IN 2017. HE WAS ATTEMPTING TO SAMPLE AN ENLARGED PERIPHERAL NODE AT 11R, AFTER HIS USUAL SUPPLIER OF NEEDLES WAS UNABLE TO SUPPLY HIS USUAL EQUIPMENT. DR (B)(6) DESCRIBED FEELING THE NODE EXTREMELY DIFFICULT TO PUNCTURE ON THE FIRST PASS, AND THE DEVICE FEELING CLUNKY WITH RESISTANCE. AFTER RECEIVING NO TISSUE HE ATTEMPTED A SECOND PASS WHERE SOMETHING "FELT WRONG". THE DEVICE WAS REMOVED AND A SECOND USED TO COMPLETE THE PROCEDURE. AFTER DISCUSSING THE PROPER TECHNIQUE REQUIRED FOR THE PC DEVICE, IT WAS APPARENT DR (B)(6) HAD REMOVED THE STYLET PRIOR TO HIS INITIAL PASS INTO 11R. I EXPLAINED WHY THIS IS THE INCORRECT PROCEDURE FOR PROCORE, HE ALSO THEN RECALLED MARK INFORMING HIM OF THIS DURING HIS INITIAL CONVERSATION. UPON INSPECTING THE DEVICE, THE NEEDLE TIP IS COMPLETELY SHEARED FROM THE DEVICE, AT APPROXIMATELY 1 CM HOWEVER, THIS WAS RETRIEVED, DURING SCOPE STERILISATION. AND WILL BE RETURNED WITH THE DEVICE IN QUESTION. MOVING FORWARD ALL CONSULTANTS HAVE AGREED TO HAVE ME PRESENT

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7714414 ↗
• MalfunctionJul 19, 2018Retraction Problem; Retraction Problem

  NOTE: NEEDLE HAD TO BE CUT OUT OF ENDOSCOPE (SO IT'S BROKEN OFF). AS REPORTED TO CUSTOMER RELATIONS: "JUST WANTED TO LET YOU KNOW DR. (B)(6) HAD A 22 GAUGE CORE NEEDLE TODAY THAT BENT 90 DEGREES AFTER AT LEAST 4 PASSES. WE COULD NOT PULL NEEDLE BACK INTO SHEATH. WE ENDED UP ADVANCING NEEDLE FURTHER OUT SCOPE ,IT THEN STRAIGHTENED ENOUGH TO SAFELY PULL SCOPE WITH NEEDLE OUT OF PATIENT. SCOPE AND PATIENT ARE FINE. THE NEEDLE WOULD NOT RETRACT INTO THE SHEATH EVEN AFTER ADVANCING IT SO WE PULLED SCOPE WITH NEEDLE DOWN SCOPE OUT OF PATIENT. I HAVE SAVED THE NEEDLE FOR YOU I HAD TO CUT THE NEEDLE TIP TO REMOVE IT FROM SCOPE. ALL PARTS ARE IN PACKAGE AT OUR NURSING STATION. LOT #C1467980. DOCTOR WAS ABOUT TO TAKE HER 5TH SAMPLE FROM 4R WHEN WE NOTICED THE BENT NEEDLE ON THE SCREEN. SHE HAD BEEN HAVING TROUBLE AND HITTING TRACHEAL RINGS. WE ENDED UP USING A NEW 22 GA CORE NEEDLE TO FINISH OUR SAMPLES." ADDITIONAL INFORMATION PROVIDED BY PHYSICIAN ON 21JUN2018: "WHEN I ADVANCED THE NEEDLE FURTHER, IT DID NOT FULLY STRAIGHTEN. IT STILL MAINTAINED A SIGNIFICANT BEND IN IT AND AT NOW POINT COULD I RETRACT IT. BY ADVANCING IT FURTHER IT ALLOWED FOR IT TO ARC A BIT MORE SO IT WASN'T AS SHARP AN

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7702772 ↗
• MalfunctionMar 20, 2018Kinked; Kinked

  AFTER THE NEEDLE WAS USED (PASS) AND AFTER THE SAMPLE WAS EXPRESSED ONTO THE SLIDE, THE STYLET WOULD NOT ADVANCE BACK INTO THE NEEDLE. PROXIMAL NEEDLE KINK WAS NOTED DURING THE DEVICE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7353074 ↗
• MalfunctionFeb 6, 2018Bent; Kinked; Bent; Kinked

  WHILE ATTEMPTING TO TAKE TRANS BRONCHIAL BIOPSY THE STYLET JAMMED INSIDE THE NEEDLE AND WAS UNABLE TO BE REMOVED EVEN WITH EXCESS FORCE. THE DEVICE WAS EVALUATED ON THE 12 JAN 2018 AND THE NEEDLE WAS CONFIRMED TO KINKED BELOW THE SHEATH EXTENDER.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7243847 ↗
• MalfunctionJan 11, 2018Activation, Positioning or Separation Problem; Activation, Positioning or Separation Problem

  ON (B)(6) 2017 - THE PHYSICIAN WAS ATTEMPTING TO SAMPLE NODES 7 AND 10 R AND EXPERIENCED A LITTLE DIFFICULTY ADVANCING THE NEEDLE ALL THE WAY THROUGH THE SCOPE. UPON STRAIGHTENING THE SCOPE FURTHER, ADVANCEMENT OF NEEDLE TO HUB WAS ACHIEVED. THE SAMPLE AT SITE WAS PERFORMED AND UPON CLEANING SCOPE, AN AIR LEAK WAS NOTED AT THE DISTAL END APPROXIMATELY ONE AND A HALF INCHES OF THE SCOPE. THE SCOPE CHANNEL WAS DAMAGED AND PUNCTURED. THE PHYSICIAN LOVES THE NEEDLE AS IT OBTAINS ADEQUATE SAMPLING ON 1ST OR 2ND PASS. DM MET WITH ONE OF THE PHYSICIANS AND DISCUSSED USING A 25 GAUGE NEEDLE FOR LYMPH NODE #7 SAMPLING DUE TO FLEXIBILITY OVER NEEDLE OVER THE 22 GAUGE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7181570 ↗
• InjuryNov 9, 2017Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PNEUMO MEDIASTINAL COMPLICATION 9 HOURS AFTER PROCEDURE ENDED NO BLEEDING DURING THE PROCEDURE. DOCTOR GAVE ME THIS MORNING FOLLOWING INFORMATION : NO PROBLEM MET, NO TECHNICAL DIFFICULTY MET DURING PUNCTION. PROCEDURE STARTED AROUND 8:30AM, ENDED BEFORE 10:00AM. COMPLICATION OCCURRED NEARLY 7:00PM, AS TO SAY 9 HOURS AFTER THE PROCEDURE ENDED. PATIENT REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION. PATIENT HAD A SUBCUTANEOUS EMPHYSEMA. SHE WENT TO NEAREST HOSPITAL EMERGENCY DEPARTMENT, THEN TRANSFERRED TO (B)(6). PATIENT HAS BEEN CHECKED WITH THORACIC SCAN THEN REMAINED UNDER FOLLOW UP WITH A POSITIVE AND SPONTANEOUS EVOLUTION WITHIN 3 DAYS.

  Patient problems: Mediastinal Shift; Pulmonary Emphysema

  MAUDE report 7013345 ↗
• InjurySep 26, 2017Break; Break

  AFTER LYMPH NODE PUNCTURE, REMOVED THE STYLET AND REALISED THAT THE NEEDLE WAS BROKEN. THEY HAD TO USE A FORCEPS WITH THE BRONCHOSCOPE TO REMOVE THE PEACE OF NEEDLE LEFT INSIDE THE LYMPH NODE.

  Patient problems: Foreign Body In Patient

  MAUDE report 6893346 ↗
• MalfunctionSep 13, 2017Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DURING TWO PASSES WHILE PERFORMING AN EBUS, THE NEEDLE WAS LOCKED THE NEEDLE IN PLACE AFTER BEING SET UP, IT WAS DOUBLE CHECKED THAT IT WAS FIRMLY LOCK; THE NEEDLE WAS FIRED, ONLY TO DISCOVER THAT THE NEEDLE LOCKING MECHANISM SOMEHOW LOOSENED AND THE NEEDLE THROW WENT FARTHER THAN INTENDED. USER COMMENT: "I ALWAYS LOCK THE NEEDLE IN TIGHTLY AND DOUBLE CHECK AND NEVER HAVE HAD THIS HAPPEN BEFORE."

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6861473 ↗
• MalfunctionAug 3, 2017Break; Break

  THIS FOLLOW UP MDR IS DUE TO BE SUBMITTED AS THE DEVICE WAS RE-EVALUATED. THE DOCTOR WAS PERFORMING PASSES WITH THE NEEDLE, AFTER THE THIRD PASS HE NOTICED THAT THE STYLET WAS NOT ENTERING THE SHEATH SO HE PULLED IT OUT OF THE PATIENT AND TOOK IT OUT ON A SLIDE, THE NEEDLE WAS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6762799 ↗
• MalfunctionJun 9, 2017Break; Break

  PRODUCT COULD NOT BE FIXATED. "AS PER COMPLAINT FORM": THE SCOPE WAS INTO THE PATIENT INTO THE CORRECT POSITION DR (B)(6) WANTED TO FIX THE SHEATH ADJUSTER, THE HANDLE IS BROKEN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6629123 ↗
• MalfunctionApr 27, 2017Retraction Problem; Retraction Problem

  PER REP - PHYSICIAN ATTEMPTED TO ADVANCE NEEDLE. EXPERIENCED DIFFICULTY. NEEDED TO WITHDRAW NEEDLE. UNABLE TO WITHDRAW NEEDLE INTO SCOPE. WITHDREW SCOPE AND NEEDLE SIMULTANEOUSLY AND DISCOVERED THAT A PORTION OF THE NEEDLE WAS BENT AT A 90 DEGREE ANGLE, HENCE, THE REASON WHY THE NEEDLE WOULD NOT GO BACK INTO THE CATHETER. NEEDLE WAS CUT OFF AT DISTAL END AND DISCONNECTED FROM SCOPE. DURING SCOPE CLEANING, IT WAS OBSERVED THAT SCOPE DAMAGE HAD OCCURRED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6525575 ↗
• InjuryMar 23, 2017Break; Break

  AS REPORTED TO CUSTOMER RELATIONS: "THE PHYSICIAN WAS ADVANCING THE NEEDLE INTO A HARD NODE AND THE NEEDLE BENT. THE PHYSICIAN USED SOME FORCE AND THE NEEDLE SNAPPED. THE TIP OF THE NEEDLE WAS ABLE TO "BE RETRIEVED" SUCCESSFULLY WITH BIOPSY FORCEPS. A NEW PRODUCT WAS USED TO COMPLETE THE PROCEDURE. THERE WAS NO HARM TO THE PATIENT."

  Patient problems: Foreign Body In Patient

  MAUDE report 6427065 ↗
• InjuryMar 6, 2017Break; Break

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: "IT WAS A STRAIGHT FORWARD PROCEDURE UNTIL THEN - WE USED 2 NEEDLES AS IS MY USUAL PRACTICE - 2 SAMPLES TAKEN FOR MICRO (LIKELY TB) AND ON OUR 4TH PASS FOR HISTOPATH (6TH OVERALL AND 3RD WITH THIS NEEDLE) INTO THE SUBCARINAL NODE, WE SAW THE NEEDLE ENTER THE NODE AS USUAL AND THEN - I THINK - THE PATIENT COUGHED, WE LOST US IMAGE WITH FUZZY SCREEN, AND SECRETIONS BLOCKING ENDOBRONCHIAL VIEW. AS I WITHDREW THE NEEDLE, I ENCOUNTERED A LITTLE RESISTANCE, BUT USING VERY LITTLE FORCE, SOMETHING GAVE WAY. I REMOVED THE NEEDLE APPARATUS AS USUAL AND ASKED ALEX AND ADI ,THE NURSING STAFF TO LOOK AT THE NEEDLE ¿ IT HAD BROKEN AND LEFT WHAT WE ESTIMATED AS ~2CM OF NEEDLE LEFT SOMEWHERE BUT COULDN¿T SEE IT ENDOBRONCHIALLY WITH THE EBUS SCOPE. I ASSUMED IT WAS STUCK IN HIS NODE, SUGGESTIVE BUT NOT COMPLETELY CONVINCING ON US, SO WE TERMINATED THE PROCEDURE AND GOT A CT SCAN. IT WAS STUCK DISTALLY IN THE WALL OF ONE OF HIS RIGHT LOWER LOBE SUBSEGMENTAL BRONCHI ¿ WITH JUST A VERY TINY PORTION OF THE FRACTURED END IN HIS AIRWAY LUMEN

  Patient problems: Foreign Body In Patient

  MAUDE report 6379832 ↗
• InjuryMar 6, 2017Break; Break

  THIS FOLLOW UP REPORT IS BEING SUBMITTED DUE TO THE EVALUATION OF THE DEVICE INVOLVED IN THIS EVENT AND THE CONCLUSION OF THIS INVESTIGATION. INITIAL REPORT DETAILS: "IT WAS A STRAIGHT FORWARD PROCEDURE UNTIL THEN - WE USED 2 NEEDLES AS IS MY USUAL PRACTICE - 2 SAMPLES TAKEN FOR MICRO (LIKELY TB) AND ON OUR 4TH PASS FOR HISTOPATH (6TH OVERALL AND 3RD WITH THIS NEEDLE) INTO THE SUBCARINAL NODE, WE SAW THE NEEDLE ENTER THE NODE AS USUAL AND THEN - I THINK - THE PATIENT COUGHED, WE LOST US IMAGE WITH FUZZY SCREEN, AND SECRETIONS BLOCKING ENDOBRONCHIAL VIEW. AS I WITHDREW THE NEEDLE, I ENCOUNTERED A LITTLE RESISTANCE, BUT USING VERY LITTLE FORCE, SOMETHING GAVE WAY. I REMOVED THE NEEDLE APPARATUS AS USUAL AND ASKED (B)(6), THE NURSING STAFF TO LOOK AT THE NEEDLE ¿ IT HAD BROKEN AND LEFT WHAT WE ESTIMATED AS ~2CM OF NEEDLE LEFT SOMEWHERE BUT COULDN¿T SEE IT ENDOBRONCHIALLY WITH THE EBUS SCOPE. I ASSUMED IT WAS STUCK IN HIS NODE, SUGGESTIVE BUT NOT COMPLETELY CONVINCING ON US, SO WE TERMINATED THE PROCEDURE AND GOT A CT SCAN. IT WAS STUCK DISTALLY IN THE WALL OF ONE OF HIS RIGHT LOWER LOBE SUBSEGMENTAL BRONCHI ¿ WITH JUST A VERY TINY PORTION OF THE FRACTURED END IN HIS AIRWAY LUMEN. I HA

  Patient problems: Foreign Body In Patient

  MAUDE report 6379829 ↗
• MalfunctionJan 12, 2017Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available; Break; Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available

  FOLLOW UP REQUIRED BASED ON DEVICE EVALUATION AND RE-CATEGORISATION OF THIS COMPLAINT FROM A NEEDLE BREAKAGE TO A POSSIBLE NON RETRACTION COMPLAINT. AS REPORTED TO CUSTOMER RELATIONS: "THE DOCTOR FELT IT WAS A DEFECTIVE TIP." BASED ON THE LABORATORY EVALUATION RECEIVED ON THE 20-JAN-2017: IT WAS NOTED THAT THE NEEDLE WAS OUT OF THE SHEATH ON RETURN. THERE WAS "NO DAMAGE TO TIP" AND DEVICE "ADVANCES/RETRACTS FINE". THERE WAS "NO DEFECT" NOTED DURING THE EVALUATION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6245177 ↗