Expect Pulmonary M00558250Recalls & reported problems

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 08714729861416), received between Nov 28, 2016 and Sep 29, 2026 — classified as 4 injuries, 32 malfunctions.

The most frequently reported specific device problem is “Bent” (25 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 36 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 29, 2026Material Puncture/Hole; Difficult to Advance

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50936396 ↗
• MalfunctionApr 11, 2026Obstruction of Flow; Device Contamination with Chemical or Other Material; Material Integrity Problem; Physical Resistance/Sticking

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 22GA WAS USED FOR MEDIASTINAL LYMPH NODE IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2026. DURING THE PROCEDURE, IT WAS REPORTED THAT THE LUER LOCK WAS CRACKED, AFTER ABOUT 7 PASSES OF THE NEEDLE, MAKING IT IMPOSSIBLE TO FLUSH THE NEEDLE WITH WATER OR AIR TO EXPEL THE SPECIMEN. ADDITIONALLY, LITTLE BLACK PIECES OF FOREIGN MATERIAL WERE FOUND IN THE SPECIMEN JAR. THE PROCEDURE WAS COMPLETED WITH ANOTHER NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24852033 ↗
• MalfunctionJun 13, 2025Material Puncture/Hole; Material Puncture/Hole

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN EBUS (ENDOBRONCHIAL ULTRASOUND) BRONCHOSCOPY PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE TIP OF THE NEEDLE CAME OUT OF THE SHEATH. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22202918 ↗
• MalfunctionMar 25, 2025Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem; Detachment of Device or Device Component; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS WAS USED DURING AN EBUS PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, A SMALL FLECK OF METAL CAME OUT OF THE NEEDLE SHAFT. THEY WERE ABLE TO RETRIEVE THE PIECE. THERE WAS NO PATIENT INJURY DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21687286 ↗
• MalfunctionDec 13, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE AIRWAY DURING PROCEDURE ON (B)(6) 2024. DURING THE PROCEDURE, THE DISTAL TIP BROKE AFTER BIOPSYING A LYMPH NODE. THE PROCEDURE WAS COMPLETED USING ANOTHER EXPECT PULMONARY NEEDLE. THERE WERE NO REPORTED PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20925535 ↗
• InjuryJun 21, 2024Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNGS DURING A BRONCHOSCOPY PROCEDURE PERFORMED ON (B)(6) 2024. DURING THE PROCEDURE, A STRANGE BODY THAT APPEARED TO BE A PLASTIC FILAMENT CAME OUT OF THE NEEDLE. THE NEEDLE WAS REMOVED, AND THE STRANGE BODY WAS ASPIRATED TO REMOVE FROM THE BRONCHIAL TREE. ANOTHER EXPECT PULMONARY NEEDLE WAS USED TO COMPLETE THE PROCEDURE. THERE WERE NO PATIENT COMPLICATIONS AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19585309 ↗
• MalfunctionMar 1, 2021Break; Appropriate Device Problem Term/Code Not Available; Break; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE DISTAL TIP OF THE NEEDLE WAS FRACTURED AND THE METAL PART OF THE NEEDLE BASICALLY SPLIT IN TWO AND FRAYED OUT. THE PROCEDURE WAS NOT COMPLETED SUCCESSFULLY. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11396508 ↗
• MalfunctionJan 26, 2021Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available; Material Twisted/Bent; Appropriate Device Problem Term/Code Not Available

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY NEEDLE WAS USED IN THE LYMPH NODE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2021. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE PHYSICIAN ATTEMPTED TO OBTAIN THE SPECIMEN AND IT WAS SEEN ON THE ULTRASOUND SCREEN THAT THE NEEDLE WAS BENT. THE DEVICE WAS REMOVED FROM THE SCOPE AND IT WAS NOTICED THAT THE DISTAL TIP WAS BENT. THE PROCEDURE WAS CANCELLED DUE TO THIS EVENT. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT.

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

  MAUDE report 11233430 ↗
• InjuryDec 7, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. MANUFACTURER REPORT # 3005099803-2018-61843 PERTAINS TO THE FIRST EXPECT PULMONARY DEVICE AND MANUFACTURER REPORT # 3005099803-2018-61844 PERTAINS TO THE SECOND EXPECT PULMONARY DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXPECT PULMONARY TRANSBRONCHIAL ASPIRATION NEEDLES WERE USED WITH A SCOPE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AFTER USE OF THE NEEDLES IN THE PATIENT, THERE WAS A SMALL BLACK PIECE OF FOREIGN MATERIAL LEFT INSIDE THE PATIENT. THE FOREIGN MATERIAL WAS REMOVED USING FORCEPS. THE SCOPE AND BOTH NEEDLES WERE INSPECTED AND NEITHER APPEARED DAMAGED, AND IT WAS UNCLEAR WHICH DEVICE THE FOREIGN MATERIAL CAME FROM. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL TWO EXPECT PULMONARY NEEDLES. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8143877 ↗
• InjuryDec 7, 2018Device Contamination with Chemical or Other Material; Device Contamination with Chemical or Other Material

  NOTE: THIS REPORT PERTAINS TO ONE OF TWO DEVICES USED IN THE SAME PROCEDURE. THIS MANUFACTURER REPORT PERTAINS TO THE FIRST EXPECT PULMONARY DEVICE AND MANUFACTURER REPORT # 3005099803-2018-61844 PERTAINS TO THE SECOND EXPECT PULMONARY DEVICE. IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT TWO EXPECT PULMONARY TRANSBRONCHIAL ASPIRATION NEEDLES WERE USED WITH A SCOPE DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE ON (B)(6) 2018. ACCORDING TO THE COMPLAINANT, AFTER USE OF THE NEEDLES IN THE PATIENT, THERE WAS A SMALL BLACK PIECE OF FOREIGN MATERIAL LEFT INSIDE THE PATIENT. THE FOREIGN MATERIAL WAS REMOVED USING FORCEPS. THE SCOPE AND BOTH NEEDLES WERE INSPECTED AND NEITHER APPEARED DAMAGED, AND IT WAS UNCLEAR WHICH DEVICE THE FOREIGN MATERIAL CAME FROM. THE PROCEDURE WAS COMPLETED WITH THE ORIGINAL TWO EXPECT PULMONARY NEEDLES. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

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

  MAUDE report 8143873 ↗
• MalfunctionAug 2, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE BRONCHIAL TUBE DURING AN ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THERE WAS DIFFICULTY PUNCTURING THE TISSUE AND WAS UNABLE TO OBTAIN A SAMPLE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT HAD NO COMPLICATION AT THE CONCLUSION OF THE PROCEDURE. THE INVESTIGATION FOUND THE DISTAL END OF THE NEEDLE WAS BENT, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6760392 ↗
• MalfunctionJul 26, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE. ACCORDING TO THE COMPLAINANT, DURING UNPACKING THE PHYSICIAN WAS UNABLE TO ADJUST THE SHEATH. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY OLYMPUS. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS. NEEDLE DISTAL TIP BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6744472 ↗
• MalfunctionJul 24, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN L4 DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DISTAL END OF THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6737140 ↗
• MalfunctionJul 5, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE WHILE INSERTING THE DEVICE INTO THE SCOPE, THE NEEDLE WAS ALREADY BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. ATTEMPTS TO OBTAIN ADDITIONAL INFORMATION REGARDING THE CIRCUMSTANCES SURROUNDING THIS EVENT HAVE BEEN UNSUCCESSFUL TO DATE. SHOULD ADDITIONAL RELEVANT DETAILS BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6687923 ↗
• MalfunctionJul 4, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE DISTAL TRACHEA DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DISTAL END OF THE NEEDLE WAS BENT WHILE TRYING TO ENTER A LYMPH NODE. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6685391 ↗
• MalfunctionJul 3, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE LUER OF THE ASPIRATION PORT CRACKED WHILE CONNECTING THE SYRINGE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD. THE INVESTIGATION FOUND THE DISTAL END OF THE NEEDLE WAS BENT, THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6684870 ↗
• MalfunctionJul 3, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED DURING AN ENDOBRONCHIAL ULTRASOUND - TRANSBRONCHIAL NEEDLE ASPIRATION (EBUS-TBNA) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DISTAL END OF THE NEEDLE WAS BENT CAUSING IT TO BE NOT VISIBLE UNDER THE ULTRASOUND. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6684866 ↗
• MalfunctionJun 13, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE THE DISTAL END OF THE NEEDLE WAS BENT AND GOT STUCK INTO THE SCOPE SO THEY HAVE TO CUT THE NEEDLE TO BE ABLE TO REMOVED IT FROM SCOPE. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE STABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6636259 ↗
• MalfunctionJun 1, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE ASPIRATION PORT CRACKED AND THEY WERE UNABLE TO PASS SALINE OR AIR THROUGH IT. THE PROCEDURE WAS COMPLETED WITH THIS DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; DISTAL END OF THE NEEDLE WAS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6605019 ↗
• MalfunctionJun 1, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE LUNGS DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017.   ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, WHILE RE-INSERTING THE STYLET BACK INTO THE DEVICE IT GOT KINKED. THE PROCEDURE WAS COMPLETED WITH A DIFFERENT DEVICE.   THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THIS EVENT HAS BEEN DEEMED A REPORTABLE EVENT BASED ON THE INVESTIGATION RESULTS; DISTAL END OF THE NEEDLE WAS BENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6604565 ↗
• MalfunctionMar 7, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS NEEDLE DEVICE WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE WOULD NOT ACTUATE DURING THE FIRST PASS. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THE INVESTIGATION FOUND THAT THE DISTAL SECTION OF THE NEEDLE WAS BENT. THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385084 ↗
• MalfunctionMar 7, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT EXPECT PULMONARY OLYMPUS NEEDLE WAS USED AT STATION 7 OF THE PATIENT'S AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER SEVERAL PASSES THE RESPIRATORY THERAPIST WAS UNABLE TO FLUSH AIR THROUGH THE NEEDLE. LEAKING OF AIR WAS HEARD AT THE TOP OF THE HANDLE. REPORTEDLY, BUBBLES WERE ALSO VISIBLE AND NOTHING WAS FLUSHED OUT OF THE DISTAL END OF THE NEEDLE. THE PROCEDURE WAS COMPLETED WITH ANOTHER OF THE SAME DEVICE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THE INVESTIGATION OF THE RETURNED DEVICE FOUND THE DISTAL TIP OF THE NEEDLE WAS BENT. THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6385030 ↗
• MalfunctionMar 3, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY OLYMPUS 25GA NEEDLE WAS USED IN THE NODE 2R OF THE TRACHEA DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, THE NEEDLE BENT ABOUT 5CM FROM THE DISTAL TIP WHILE ATTEMPTING TO TAKE SAMPLES. THE NEEDLE WAS VISIBLY WHEN REMOVED FROM THE SCOPE. A SECOND EXPECT PULMONARY OLYMPUS 25GA NEEDLE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6376016 ↗
• MalfunctionMar 2, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT AN EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2017. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE AFTER MULTIPLE PASSES THE DISTAL TIP OF THE NEEDLE WAS BENT. THE PROCEDURE WAS COMPLETED WITH ANOTHER EXPECT PULMONARY ENDOBRONCHIAL ULTRASOUND TRANSBRONCHIAL ASPIRATION NEEDLE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE GOOD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6372656 ↗
• MalfunctionFeb 14, 2017Bent; Bent

  IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT A EXPECT PULMONARY OLYMPUS 25GA NEEDLE WAS USED IN THE AIRWAY DURING AN ENDOBRONCHIAL ULTRASOUND (EBUS) PROCEDURE PERFORMED ON (B)(6) 2016. ACCORDING TO THE COMPLAINANT, DURING THE PROCEDURE, A CRACK WAS NOTED AT THE LUER OF THE HANDLE CAUSING LEAKAGE DURING FLUSHING. A SECOND EXPECT PULMONARY OLYMPUS DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO PATIENT COMPLICATIONS REPORTED AS A RESULT OF THIS EVENT. THE PATIENT'S CONDITION AT THE CONCLUSION OF THE PROCEDURE WAS REPORTED TO BE FINE. THE INVESTIGATION FOUND THE DISTAL TIP OF THE NEEDLE WAS BENT. THIS IS NOW DEEMED AN MDR REPORTABLE EVENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6330502 ↗