EchoTip G31520Recalls & reported problems

Summary

The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 00827002315204), received between Feb 16, 2016 and Aug 11, 2025 — classified as 9 injuries, 75 malfunctions.

The most frequently reported specific device problem is “Break” (38 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Apr 1, 2024Open, Classified

   Devices may contain elevated levels of bacterial endotoxin.

   Z-1833-2024 · Root cause: Nonconforming Material/Component · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 11, 2025Fracture; Fracture

  THE CASE WAS DETERMINED TO BE REPORTABLE ON 18 JUL 2025 BASED ON THE FOLLOWING ENGINEERING INPUT AFTER THE LAB EVALUATION: "IF A DISTAL KINK OR BREAK HAD BEEN PRESENT, THE ISSUE COULD HAVE BEEN ATTRIBUTED TO USE ERROR. HOWEVER, SINCE ONLY A PROXIMAL BREAK IS EVIDENT, THIS COMPLAINT WILL BE ASSESSED AS A PROXIMAL NEEDLE BREAK. USER WAS CONDUCTING EUS PANCREAS, PUNCTURE PANCREAS BODY FOR FIRST ATTEMPT, THEN SLOWLY RETRACTED THE NEEDLE BUT FOUND OUT NO CELL OBTAINED. USER RETRACTED THE NEEDLE FROM ENDOSCOPE WORKING CHANNEL, THEN RE-INSTALLED THE NEEDLE ONTO ENDOSCOPE WHILE ENCOUNTERED RESISTANCE DURING INSERTING INTO ENDOSCOPE. USER FOUND OUT THE NEEDLE KINK AND CHANGED TO ANOTHER ONE 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. 1. CAN THE FOLLOWING BE CONFIRMED WITH THE CUSTOMER? COULD YOU PLEASE CLARIFY WHETHER THE NEEDLE WAS KINKED AT THE PROXIMAL END, THE DISTAL END, OR BOTH? THE IMAGES SUGGEST THAT KINKS MAY BE PRESENT AT BOTH LOCATIONS. PROXIMAL E

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22769653 ↗
• MalfunctionFeb 14, 2020Fracture; Fracture

  COMPLETED CUSTOMER REPORTING FORM AND ADDITIONAL INFORMATION WAS RECEIVED ON 17-JAN-2020 INDICATING NEEDLE BREAKAGE. THE COMPLAINT DEVICE WAS EVALUATED ON (B)(6) 2020 AND THE NEEDLE WAS CONFIRMED TO BE BROKEN BELOW THE SHEATH EXTENDER. DURING DECOMPRESSION OF THE CYST, THE NEEDLE BROKE AFTER PASSING THROUGH THE CANAL AND TRYING TO OPEN THE NEEDLE IN THE STOMACH. THE NEEDLE WAS NO LONGER HIDDEN IN THE COVER.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9710412 ↗
• MalfunctionJan 24, 2020Break; Fracture; No Apparent Adverse Event; Break; Fracture; No Apparent Adverse Event

  DURING ECHO ENDOSCOPY WITH BIOPSY, WHEN STAFF WANTED TO MAKE A PONCTION, DIFFICULTY TO GET THE NEEDLE OUT OF THE ECHOENDO. NEEDLE BROKE OFF INTO ECHOENDOSCOPE. WHEN NEEDLE WAS RETRIEVED STAFF NOTICED A LACK OF BEVELLED EDGE. CONSEQUENCES: LONGER ANESTHESIA. USE OF NEW NEEDLE. EXTRA FINANCIAL COST.

  Patient problems: No Clinical Signs, Symptoms or Conditions; No Consequences Or Impact To Patient

  MAUDE report 9625563 ↗
• MalfunctionJan 16, 2020Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T FUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE.SO THEY USED ANOTHER ECHO-19. IT WAS INDICATED THAT THE DISTAL END OF THE NEEDLE WAS KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9596216 ↗
• MalfunctionDec 19, 2019Material Twisted/Bent; Material Twisted/Bent

  DISTAL TIP OF NEEDLE DEFORMED OBSERVED DURING THE LAB EVALUATION OF (B)(4). RELATED TO MDR REF#: 3001845648-2019-00594.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9494096 ↗
• MalfunctionNov 25, 2019Break; Retraction Problem; Break; Retraction Problem

  ON (B)(6) 2019 THE PATIENT UNDERWENT PUNCTURE ECHOENDOSCOPE DUE TO OESOPHAGEAL SUB EPITHELIAL LESION. THE ECHO NEEDLE WAS INTRODUCED THROUGH THE WORKING CHANNEL OF THE DEVICE AND EXPOSED TO THE SHEATH POSITIONED FOR THE ECHO GUIDED PUNCTURE, AND WHEN THE NEEDLE WAS INSERTED INTO THE LESION, A CLICK WAS HEARD AND THE NEEDLE DID NOT PROGRESS PROPERLY. AN ATTEMPT WAS MADE TO RETRACT THE NEEDLE INTO THE SHEATH WITHOUT SUCCESS. THE NEEDLE WAS REMOVED AND ANOTHER ONE WITH THE SAME SPECIFICATIONS WAS USED TO COMPLETE THE PROCEDURE UNEVENTFULLY. AFTER EXAMINATION, THE NEEDLE WAS EXAMINED AND IT WAS FOUND THAT THE SHEATH HAD BROKEN IN ITS PROXIMAL PORTION AND THAT THE MOVEMENTS OF THE NEEDLE HANDLE DID NOT MOVE IT FORWARD OR BACKWARD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9368352 ↗
• MalfunctionNov 14, 2019Break; Retraction Problem; Activation, Positioning or Separation Problem; Break; Retraction Problem; Activation, Positioning or Separation Problem

  DURING THE PROCEDURE THE DOCTOR NOTICED THE 19G NEEDLE WAS RATHER STIFF (DIDN`T MOVE EASILY IN AND OUT OF THE SHEET). WHILE PUNCTURING (2ND PASS) SOMETHING SNAPPED AND ON THE EUS SCREEN THE NOTICED THE NEEDLE SEEMED TO HAVE BROKEN. THEY REMOVED THE NEEDLE AND EXCHANGED IT FOR A 3-22. THEY FINISHED THE PROCEDURE WITHOUT ANY PROBLEMS.

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

  MAUDE report 9322055 ↗
• MalfunctionNov 13, 2019Material Twisted/Bent; Material Twisted/Bent

  AS REPORTED TO CUSTOMER RELATIONS ON (B)(6) 2019: "EUS POSSIBLE DRAINAGE OR ACCESS RENDEZVOUS." ADDITIONAL INFORMATION PROVIDED BY DM ON 16-OCT-2019: 'PATIENT (B)(6) FEMALE WITH SEVERE CASE OF PANCREATITIS AND COMPARTMENT SYNDROME PRESENTED WITH PANCREATIC SUDO CYST. PATIENT WAS SCHEDULED FOR AN EUS GUIDED CYSTGASTROSTOMY. PER USUAL DR (B)(6) WILL USE THE 19G ECHO TIP COOK NEEDLE FOR ACCESS OF THE CYST UNDER EUS GUIDANCE. DR (B)(6) PASSED THE SCOPE AND QUICKLY IDENTIFIED THE CYST. WE REMOVED THE NEEDLE FROM ITS PACKAGING WITH NO FORCE AND IT CAME OUT EASILY. I SET THE SHEATH TO DR (B)(6) PREFERRED SETTING AND TIGHTEN THE KNOBS AS I USUALLY DO AND HANDED IT TO HIM. THE NEEDLE ATTACHED TO OUR GFUC 180 OLYMPUS LINEAR SCOPE WITH NO TROUBLE. AS DR (B)(6) WAS LINING UP TO STICK THE CYST HE HAD MORE RESISTANCE THAN USUAL SO HE HAD ME CHECK THE NEEDLE AS IT USUALLY WORKS WITH MORE EASE. AS DR (B)(6) ATTEMPTS TO BRING THE NEEDLE BACK INTO THE PROTECTIVE SHEATH HE FELT A SNAP SO HE QUICKLY REMOVED THE CATHETER FROM THE SCOPE. WE ALL NOTICED THE NEEDLE WAS STILL EXPOSED AND HAD NEVER RETRACTED INTO THE SHEATH. WE ATTEMPTED TO BRING THE NEEDLE BACK INTO TO SHEATH WITH NO LUCK. WE WERE ABLE TO

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9315704 ↗
• MalfunctionNov 12, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T PUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE. SO THEY USED ANOTHER ECHO-19.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9308979 ↗
• MalfunctionSep 10, 2019Material Perforation; Material Perforation

  THE DEVICE WAS USED FOR EUS-FNA OF THE PANCREAS TUMOR SINCE PANCREATIC CANCER WAS SUSPECTED. APPROACH WAS GAINED FROM THE STOMACH TO THE PANCREATIC BODY. THE APPROACH, FROM THE STOMACH TO THE PANCREATIC BODY, WAS COMPARATIVELY SIMPLE, SO THE ENDOSCOPE WAS ALMOST NOT IN AN ANGLED POSITION. ONE ECHO-19/ LOT# C1332149 WAS INSERTED THROUGH THE ENDOSCOPE. WHEN THE PHYSICIAN MOVED THE HANDLE TO RETRACT THE NEEDLE AFTER NEEDLE ADVANCEMENT TO THE TARGET SITE, THE NEEDLE DID NOT MOVE AND COULD NOT BE RETRACTED INTO THE SHEATH ALTHOUGH THE HANDLE COULD BE MOVED. THEREFORE, THE DEVICE WAS REMOVED THROUGH THE ENDOSCOPIC CHANNEL WITH THE NEEDLE PROTRUDING OUT OF THE SHEATH AND REPLACED WITH ECHO-19/ LOT# C1483682. (B)(4) ONE ECHO-19/ LOT# C1483682 WAS INSERTED THROUGH THE ENDOSCOPE. WHEN THE PHYSICIAN ATTEMPTED PUNCTURE OF THE TARGET SITE, THE NEEDLE DID NOT MOVE AND COULD NOT ADVANCE OUT OF THE SHEATH. HE REPEATED MOVEMENT OF WITHDRAWAL AND ADVANCEMENT OF THE DEVICE THROUGH THE ENDOSCOPE SEVERAL TIMES, BUT THE NEEDLE WOULD NOT ADVANCE. HE REMOVED THE ENTIRE DEVICE THROUGH THE ENDOSCOPIC CHANNEL, THEN NOTICED THAT THE NEEDLE PERFORATED THE SHEATH AT A CERTAIN POINT. ALSO, THE TIP OF THE SHEATH

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984284 ↗
• InjurySep 10, 2019Break; Break

  THE NEEDLE BROKE DURING THE PROCEDURE. A CORRECTION REPORT IS BEING SUBMITTED TO CLASSIFY THIS REPORT UNDER SERIOUS INJURY. ADOPTING A CAUTIOUS APPROACH, SERIOUS INJURY REPORTING REQUIRED AS THE NEEDLE BROKE INSIDE THE PATIENT'S BODY AND THERE IS POTENTIALLY A REQUIREMENT FOR SURGICAL INTERVENTION. THE RISK OF THIS COMPLAINT WAS ASSESSED BASED ON A SEVERITY OF +3 (HARM REQUIRING MEDICAL INTERVENTION). IT SHOULD BE NOTED THAT THESE DETAILS DO NOT IMPACT THE EVALUATION CONCLUSIONS PREVIOUSLY SUBMITTED IN RELATION TO THIS EVENT.

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

  MAUDE report 8984217 ↗
• MalfunctionSep 10, 2019Retraction Problem; Retraction Problem

  THE DEVICE WAS USED FOR EUS-FNA OF THE PANCREAS TUMOR SINCE PANCREATIC CANCER WAS SUSPECTED. APPROACH WAS GAINED FROM THE STOMACH TO THE PANCREATIC BODY. THE APPROACH, FROM THE STOMACH TO THE PANCREATIC BODY, WAS COMPARATIVELY SIMPLE, SO THE ENDOSCOPE WAS ALMOST NOT IN AN ANGLED POSITION. ONE ECHO-19/ LOT# C1332149 WAS INSERTED THROUGH THE ENDOSCOPE. WHEN THE PHYSICIAN MOVED THE HANDLE TO RETRACT THE NEEDLE AFTER NEEDLE ADVANCEMENT TO THE TARGET SITE, THE NEEDLE DID NOT MOVE AND COULD NOT BE RETRACTED INTO THE SHEATH ALTHOUGH THE HANDLE COULD BE MOVED. THEREFORE, THE DEVICE WAS REMOVED THROUGH THE ENDOSCOPIC CHANNEL WITH THE NEEDLE PROTRUDING OUT OF THE SHEATH AND REPLACED WITH ECHO-19/ LOT# C1483682. (B)(4) - THIS COMPLAINT) ONE ECHO-19/ LOT# C1483682 WAS INSERTED THROUGH THE ENDOSCOPE. WHEN THE PHYSICIAN ATTEMPTED PUNCTURE OF THE TARGET SITE, THE NEEDLE DID NOT MOVE AND COULD NOT ADVANCE OUT OF THE SHEATH. HE REPEATED MOVEMENT OF WITHDRAWAL AND ADVANCEMENT OF THE DEVICE THROUGH THE ENDOSCOPE SEVERAL TIMES, BUT THE NEEDLE WOULD NOT ADVANCE. HE REMOVED THE ENTIRE DEVICE THROUGH THE ENDOSCOPIC CHANNEL, THEN NOTICED THAT THE NEEDLE PERFORATED THE SHEATH AT A CERTAIN POINT. ALSO, THE

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8984216 ↗
• MalfunctionAug 29, 2019Failure to Advance; Failure to Advance

  NEEDLE CANNOT BE ADVANCED IN ENDOSCOPY. USER TRIED SEVERAL TIMES BUT FAILED. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE BIOPSY. DEVICE EVALUATED AND A DISTAL KINK ON THE NEEDLE WAS OBSERVED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8944399 ↗
• MalfunctionAug 28, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T FUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE. SO THEY USED ANOTHER ECHO-19. ADDITIONAL INFORMATION CONFIRMED THAT THE NEEDLE WAS KINKED AT THE DISTAL END.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8939199 ↗
• MalfunctionAug 21, 2019Break; Break

  DEVICE WAS ADVANCED TO TARGET AREA AND 3 ATTEMPTS WERE COMPLETED. USER CANNOT ADVANCE THE NEEDLE AFTER THIRD ATTEMPT, AND FOUND OUT THE NEEDLE BROKEN UNDER ENDOSCOPY VIEW. USER CHANGED ANOTHER SAME DEVICE TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8915547 ↗
• MalfunctionAug 1, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T FUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE.SO THEY USED ANOTHER ECHO-19.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8850175 ↗
• MalfunctionJul 25, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T PUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE WAS REMOVED OUT OF THE SCOPE. SO THEY USED ANOTHER ECHO-19 DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826586 ↗
• MalfunctionJul 25, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T PUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE WAS REMOVED OUT OF THE SCOPE.SO THEY USED COMPETITOR EUS NEEDLE. (MEDIGLOBE 19G).

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826584 ↗
• MalfunctionJul 25, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T PUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE WAS REMOVED OUT OF THE SCOPE. SO THEY USED ANOTHER ECHO-19 DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8826553 ↗
• MalfunctionJul 18, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T PUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE. SO THEY USED ANOTHER ECHO-19. DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED ON 20-JUN-2019. THE TIP OF THE NEEDLE WAS NOTED TO BE DEFORMED - OVERALL RISK ASSESSED AS CATEGORY IIB (MODERATE). NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. FDA MDR REPORTING REQUIRED AS THE RISK IS NOT CONSIDERED TO BE 'REMOTE'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802338 ↗
• MalfunctionJul 18, 2019Material Twisted/Bent; Material Twisted/Bent

  THEY CHECKED THAT MASS LOCATION WAS BODY OF PANCREAS BEFORE THE PROCEDURE IN EUS. THEY ADVANCED ECHO-19 TO MASS IN THROUGH THE SCOPE. HOWEVER, THE NEEDLE DIDN'T PUNCTURE TO MASS IN EUS. CONSEQUENTLY, THE NEEDLE REMOVED OUT OF THE SCOPE. SO THEY USED ANOTHER ECHO-19. DEVICE RELATED TO THIS COMPLAINT WAS EVALUATED ON 20-JUN-2019. THE TIP OF THE NEEDLE WAS NOTED TO BE DEFORMED - OVERALL RISK ASSESSED AS CATEGORY IIB (MODERATE). NO ADVERSE EFFECTS TO THE PATIENT WAS REPORTED AS OCCURRING. FDA MDR REPORTING REQUIRED AS THE RISK IS NOT CONSIDERED TO BE 'REMOTE'.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8802281 ↗
• InjuryJul 12, 2019Break; Break

  ABOUT 3 INCHES BROKE OFF OF THE NEEDLE INSIDE A PATIENT. THE NEEDLE WAS USED TO ACCESS THE CYST-GASTRIC CAVITY. THE PHYSICIAN WAS ABLE TO RETRIEVE THE PIECE THAT WAS LEFT IN THE PATIENT. STAFF NOR PHYSICIAN NOTED ANYTHING UNTOWARD WITH THE NEEDLE DURING SET-UP OR INITIAL USE.

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

  MAUDE report 8783927 ↗
• MalfunctionJun 13, 2019Retraction Problem; Retraction Problem

  DURING THE HEPATOGASTROSTOMY PROCEDURE, THE NEEDLE ECHO-19 WAS USED. THE NEEDLE WAS CHECKED BEFORE THE PROCEDURE. BOTH THE PACKAGING AND THE SHEATH WERE INTACT. AFTER USE, THE NEEDLE WAS WITHDRAWN AND THE NEEDLE-OUT MARKER PLACED IN AND LOCKED INTO THE "ZERO" POSITION. AFTER REMOVING THE NEEDLE FROM THE ENDOSCOPE CHANNEL, IT TURNED OUT THAT THE TIP OF THE NEEDLE DID NOT HIDE INTO THE SHEATH, SO THAT WHEN IT WAS REMOVED, THE ENDOSCOPE'S BIOPSY CANAL WAS DAMAGED. THE ENDOSCOPE HAS BEEN SENT BACK FOR REPAIR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8695632 ↗
• MalfunctionMay 23, 2019Material Twisted/Bent; Material Twisted/Bent

  WHEN DOCTOR TRIED TO PUNCTURE THE PREUDOCYST, IT DID NOT PUNCTURE. THE DOCTOR REMOVED NEEDLE FROM THE SCOPE AND FOUND THAT NEEDLE WAS BEND FROM THE TIP. DOCTOR USED ANOTHER ECHO-19 TO COMPLETE THE PROCEDURE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8636621 ↗
• MalfunctionMay 16, 2019Material Twisted/Bent; Material Twisted/Bent

  AS PER SOURCE DOCUMENT: IMPOSSIBLE TO ADVANCE THE NEEDLE. AS PER COMPLAINT FORM: "IT IS IMPOSSIBLE TO GET THE NEEDLE INTO THE LESION."

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8615764 ↗