Single Use Aspiration Needle NA-U200H NA-U200H-8019Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 04953170380402), received between Jan 11, 2022 and Dec 18, 2025 — classified as 2 deaths, 18 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Break” (3 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 18, 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 18, 2025Break; Break

  NO ADDITIONAL INFORMATION RECEIVED FROM THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23838526 ↗
• InjuryAug 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿TRANSLUMINAL ANTEGRADE DRILL DILATION TECHNIQUE FOR HEPATICOJEJUNOSTOMY STRICTURE WITH CHOLANGIOSCOPIC EVALUATION (WITH VIDEO)¿. BACKGROUND AND STUDY AIMS : BALLOON DILATION AND PLASTIC STENT DEPLOYMENT HAVE BEEN PERFORMED AS HEPATICOJEJUNOSTOMY STRICTURE (HJS) TREATMENT TECHNIQUES UNDER ENDOSCOPIC ULTRASOUND GUIDANCE (EUS). ALTHOUGH THESE TECHNIQUES HAVE SHOWN FAVORABLE CLINICAL RESULTS, THE TREATMENT PERIOD CAN BE LONG BECAUSE STENT DEPLOYMENT IS REQUIRED. IN ADDITION, HJS MAY RECUR EVEN AFTER TREATMENT BECAUSE THE SCAR TISSUE ITSELF REMAINS. TO OVERCOME THESE CHALLENGES, WE DEVELOPED AN EUS-GUIDED ANTEGRADE DRILL DILATION TECHNIQUE FOR TREATING HJS. THE AIM OF THIS STUDY WAS TO EVALUATE THE TECHNICAL FEASIBILITY AND SAFETY OF THIS TECHNIQUE IN TERMS OF THE PRE- AND POST-CHOLANGIOSCOPIC FINDINGS. METHODS: THIS RETROSPECTIVE STUDY INCLUDED CONSECUTIVE PATIENTS WHOSE CONDITIONS WERE COMPLICATED WITH SYMPTOMATIC HJS BETWEEN NOVEMBER 2022 AND FEBRUARY 2023. TRANSLUMINAL ANTEGRADE DRILL DILATION (TAD) USING A NOVEL DRILL DILATOR WAS ATTEMPTED WITHIN 14 DAYS AFTER EUS-GUIDED HEPATICOGASTROSTOMY (HGS). HJS WAS DIAGNOSED WITH CHOLANGIOSCO

  Patient problems: Cholangitis

  MAUDE report 22926525 ↗
• MalfunctionAug 1, 2025Difficult to Remove; Difficult to Remove

  IT WAS REPORTED THE SINGLE USE ASPIRATION NEEDLE NA-U200H WAS IMPOSSIBLE TO REMOVE AFTER THE SECOND PASS. THE ISSUE OCCURRED DURING AN UNSPECIFIED PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22686234 ↗
• InjuryMar 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED FROM THE AUTHOR THAT CONFIRMED NO DEVICE MALFUNCTIONED, AND NO DEVICE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENTS.

  Patient problems: Peritonitis

  MAUDE report 21576718 ↗
• MalfunctionJan 6, 2025

  OLYMPUS SINGLE USE ASPIRATION NEEDLE WAS BENT UPON REMOVING FROM PACKAGE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21078888 ↗
• MalfunctionDec 3, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING A ENDOSCOPIC ULTRASOUND-GUIDED GALLBLADDER DRAINAGE THERAPEUTIC PROCEDURE, THE NEEDLE BROKE OFF AND WAS DISCOVERED ON THE FLOOR. THE NEEDLE WAS DISCARDED AND THE PROCEDURE WAS COMPLETED UTILIZING AN OLYMPUS BACK-UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20833688 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: Pancreatitis

  MAUDE report 20737438 ↗
• InjuryAug 23, 2024Failure to Advance; Failure to Advance

  IT WAS REPORTED THAT DURING A PANCREATIC CYST DRAINAGE, THE DEVICE DID NOT COME OUT OF THE SHEATH. DUE TO THIS MALFUNCTION, THE PROCEDURE WAS ABORTED AND IS SCHEDULED TO BE COMPLETED 8AUG2024. THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO HEALTH PROBLEMS FOR THE PATIENT OTHER THAN THE POSTPONEMENT OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20055563 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE ARTICLE, "ERCP USING BALLOON-ASSISTED ENDOSCOPES VERSUS EUS-GUIDED TREATMENT FOR COMMON BILE DUCT STONES IN ROUX-EN-Y GASTRECTOMY." CONSECUTIVE PATIENTS WHO HAD PREVIOUS ROUX-EN-Y (R-Y) GASTRECTOMY UNDERGOING BALLOON-ASSISTED ENDOSCOPE (BE-ERCP) OR EUS-GUIDED ANTEGRADE TREATMENT (EUS-AG) FOR COMMON BILE DUCT (CBD) STONES IN 16 CENTERS WERE RETROSPECTIVELY ANALYZED. PATIENTS WHO UNDERWENT ENDOSCOPIC INTERVENTIONS BETWEEN JANUARY 2009 AND MARCH 2020 WERE ENROLLED. BALLOON-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP): TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS PANCREATITIS (23) CHOLANGITIS (7) CHOLECYSTITIS (1) MAJOR OR MINOR PERFORATION (15) LACERATION (3) BLEEDING (3) ASPIRATION PNEUMONIAE (4) RESPIRATORY FAILURE (2) PULMONARY EMBOLISM (1) BRADYCARDIA (1) ENDOSCOPIC ULTRASOUND (EUS)-GUIDED ANTEGRADE TREATMENT: TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS CHOLANGITIS (3) CHOLECYSTITIS (1) BILE PERITONITIS (2) ABDOMINAL PAIN WITH FEVER (5) THE SELECTION OF THE INTERVENTION WAS AT THE DISCRETION OF ENDO- SCOPISTS. WHEN THE INITIAL PROCEDURE FAILED, AN ALTERNATIVE TREATMENT WAS CHOSEN FROM ANOTHER ENDOSCOPIC INTERVENTION, PERCUTANEOUS TRANSHEPATIC BILI

  Patient problems: Abdominal Pain; Aspiration Pneumonitis; Bradycardia; Cholangitis; Fever; Hemorrhage/Blood Loss/Bleeding; Laceration(s); Pancreatitis; Perforation; Peritonitis; Pulmonary Embolism; Respiratory Failure

  MAUDE report 19640041 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PRELIMINARY FEASIBILITY STUDY OF A NEW PARTIALLY COVERED SELF-EXPANDABLE METAL STENT WITH AN ANCHORING FLANGE FOR EUS-GUIDED HEPATIC GASTROSTOMY (WITH VIDEOS)". TWO PATIENTS DEVELOPED CHOLANGITIS AFTER EUS-HPG AND SEVEN PATIENTS DEVELOPED RECURRENT BILIARY OBSTRUCTION (RBO). CHOLANGITIS WAS MANAGED SUCCESSFULLY BY CONSERVATIVE TREATMENT. NO SEVERE ADVERSE EVENTS (INCLUDING BILE PERITONITIS AND PROXIMAL OR DISTAL STENT MIGRATION) WERE OBSERVED. ENDOSCOPIC REINTERVENTION FOR RBO WAS SUCCESSFULLY PERFORMED USING A DUODENOSCOPE IN A RETROFLEX POSITION IN ALL PATIENTS (7/7) THROUGH THE STENT. FOUR PATIENTS WITH RBO BECAUSE OF SLUDGE FORMATION, STENT CLEANING BY BALLOON SWEEPING WAS PERFORMED WITH PLACEMENT OF AN ADDITIONAL 7F PLASTIC STENT IN 3 PATIENTS. TWO PATIENTS WITH HYPERPLASIA, STENT-IN-STENT DEPLOYMENT OF UNCOVERED METAL STENTS WAS PERFORMED. ONE PATIENT WITH NONOCCLUSIVE CHOLANGITIS, ADDITIONAL ANTEGRADE METAL STENT PLACEMENT WAS PERFORMED. THIS MEDWATCH REQUIRES TWO REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) GF-UCT260; EVIS LUCERA ULTRASOUND GASTROVIDEOSCOPE (B)(6) NA-U200H-8019; SINGLE USE ASPIRATION NEEDL

  Patient problems: Cholangitis; Obstruction/Occlusion

  MAUDE report 18351062 ↗
• InjuryDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, NO OLYMPUS DEVICE MALFUNCTION OCCURRED DURING ANY OF THE EVENTS.

  Patient problems: Peritonitis

  MAUDE report 18345711 ↗
• DeathDec 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR: AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, NO OLYMPUS DEVICE MALFUNCTION OCCURRED DURING ANY OF THE EVENTS.

  Patient problems: Peritonitis

  MAUDE report 18345691 ↗
• MalfunctionDec 12, 2023

  DEVICE WAS DEFECTIVE UPON OPENING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18310334 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PERFORMANCE OF ENDOSCOPIC ULTRASOUND-GUIDED VERSUS PERCUTANEOUS LIVER BIOPSY IN DIAGNOSING STAGE 3¿4 FIBROSIS" THIS IS A SINGLE CENTER, RETROSPECTIVE CHART REVIEW AMONG PATIENTS WITH LIVER DISEASES AT A TERTIARY ENDOSCOPY CENTER FROM FEBRUARY 2011 TO MARCH 2020. WE ASSESSED THE EUS-GUIDED BIOPSY (EUS-BX) VERSUS PERCUTANEOUS LIVER BIOPSY (P-BX) OUTCOMES BY SUCCESS RATE, PERFORMANCE, AND SAFETY PROFILE. THE PRIMARY OUTCOME WAS THE ASSOCIATION BETWEEN EUS-BX CLINICAL VARIABLES AND THE PRESENCE OF HISTOLOGIC LIVER FIBROSIS STAGE = 3. THE SECONDARY OUTCOMES WERE THE ASSOCIATIONS BETWEEN EUS-BX AND VARIABLES INDICATIVE OF FIBROSIS. RESULTS: FIFTY-NINE PATIENTS UNDERWENT EUS-BX; AND 59, P-BX. ALL EUS-BX PROCEDURES WERE SUCCESSFULLY COMPLETED. ALL 56/56 (100%) OF EUS-BX VS. 50/52 (96.2%) P-BX WERE CONSIDERED ADEQUATE SAMPLES. TISSUE LENGTHS WERE SIGNIFICANTLY LONGER IN THE EUS-BX COHORT (P < 0.0001) WITH A TREND TOWARDS A GREATER NUMBER OF PORTAL TRACTS. 46/56 (82.1%) CASES OF EUS-BX VS. 32/52 (61.5%) OF P-BX HAD > 10 PORTAL TRACTS; 21/56 (37.5%) CASES OF EUS-BX VS. 14/52 (26.9%) OF P-BX HAD > 15 PORTAL TRACTS. THERE WERE 6 (10.2%) EUS-BX V

  Patient problems: Thrombocytopenia

  MAUDE report 18041381 ↗
• InjuryOct 31, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS MEDWATCH IS BEING SUBMITTED AS A CORRECTION TO F6 AWARE DATE.

  Patient problems: Thrombocytopenia

  MAUDE report 18041365 ↗
• InjuryOct 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "COMPARING ENDOSCOPIC ULTRASOUND-GUIDED ANTEGRADE TREATMENT AND BALLOON ENDOSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN THE MANAGEMENT OF BILE DUCT STONES IN PATIENTS WITH SURGICALLY ALTERED ANATOMY: A RETROSPECTIVE COHORT STUDY". ENDOSCOPIC ULTRASOUND-GUIDED ANTEGRADE TREATMENT (EUS-AG) AND BALLOON ENDOSCOPY-ASSISTED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (BE-ERCP) HAVE EMERGED AS USEFUL PROCEDURES FOR MANAGING BILE DUCT STONES (BDS) IN PATIENTS WITH SURGICALLY ALTERED ANATOMY. HOWEVER, THE COMPARISON BETWEEN THESE TWO PROCEDURES HAS NOT BEEN WELL STUDIED. THE AIM OF OUR STUDY WAS TO COMPARE THE CLINICAL OUTCOMES OF EUS-AG AND BEERCP FOR MANAGING BDS IN PATIENTS WITH SURGICALLY ALTERED ANATOMY. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: EVENT1: BILE PERITONITIS(N=3) . EVENT2: ELEVATION OF C-REACTIVE PROTEIN (N=1). EVENT3: PANCREATITIS (N=3). EVENT4: PERFORATION (N=4). THE FOLLOWING PROCEDURE AND OLYMPUS DEVICES ARE USED IN THIS LITERATURE. (1) EUS-AG. CONVEX-TYPE EUS SCOPE (GF-UCT260). FINE-NEEDLE ASPIRATION (FNA) NEEDLE (EZ SHOT 3 PLUS : ESTIMATED AS NA-U200H-8019). RETRIEVAL BALLOON CA

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Peritonitis

  MAUDE report 17878055 ↗
• InjuryAug 4, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "GUIDEWIRE MALPOSITION OUTSIDE THE BILE DUCT DURING ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY". ENDOSCOPIC ULTRASOUND-GUIDED HEPATICOGASTROSTOMY (EUS-HGS) IS WIDELY USED IN CLINICAL PRACTICE FOR PATIENTS WITH A MALIGNANT BILIARY OBSTRUCTION AFTER FAILED ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY (ERCP) HOWEVER, THE RATE OF PROCEDURE-RELATED ADVERSE EVENTS ASSOCIATED WITH EUS-HGS IS RELATIVELY HIGH. HEREIN, WE REPORT A CASE OF GUIDEWIRE MALPOSITION DURING EUS-HGS. AN 80-YEAR-OLD MAN WITH BILIARY OBSTRUCTION DUE TO PANCREATIC CANCER WAS REFERRED TO OUR HOSPITAL FOR EUS-HGS BECAUSE OF PRIOR ERCP FAILURE. DURING THE PROCEDURE, THE BILE DUCT OF SEGMENT 3 WAS PUNCTURED USING A 19-G NEEDLE (EZ SHOT 3 PLUS; OLYMPUS MEDICAL, TOKYO, JAPAN), AND CONTRAST MEDIUM WAS INJECTED INTO THE BILE DUCT. A GUIDEWIRE (VISI- GLIDE 2 GUIDEWIRES; OLYMPUS MEDICAL) WAS ADVANCED TOWARD THE BILIARY TRACT WITHOUT RESISTANCE. AFTER DILATION OF THE FISTULA, CONTRAST WAS NOTED OUTSIDE THE BILE DUCT, SUGGESTING GUIDEWIRE MALPOSITION. EUS-HGS ON THE BILE DUCT OF SEGMENT 2 WAS PERFORMED FOR SALVAGE DRAINAGE. AFTER THE GUIDEWIRE WAS INSERTED I

  Patient problems: Hematoma

  MAUDE report 17465696 ↗
• MalfunctionJul 5, 2023Defective Component; Defective Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT WHEN USING A SINGLE USE ASPIRATION NEEDLE NA-U200H, THE GUIDEWIRE WAS STUCK AND NEEDED TO BE CUT; THE FINE-NEEDLE ASPIRATION (FNA) NEEDLE WAS THEN REMOVED. THE THERAPEUTIC PROCEDURE (ENDOSCOPIC ULTRASONOGRAPHY-GUIDED BILIARY DRAINAGE: EUS BD) WAS COMPLETED WITH A SIMILAR DEVICE. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17259516 ↗
• MalfunctionJun 29, 2023Break; Break

  AN OLYMPUS SALES REPRESENTATIVE (REP) CALLED IN TO REPORT AN OUT OF BOX FAILURE MODE ON THE CUSTOMER¿S SINGLE-USE ASPIRATION NEEDLE. ACCORDING TO THE REP, DURING AN ENDOSCOPIC ULTRASOUND PROCEDURE, THE NEEDLE BROKE. REPORTEDLY, THE STAFF COULD NOT RETRACT THE NEEDLE AND IT BOUNCED BACK AS IT CAME OUT OF THE SCOPE. ADDITIONAL DETAILS RELATING TO THE PATIENT AND THE EVENT HAVE BEEN REQUESTED, BUT NO RESPONSE HAS BEEN RECEIVED AT THIS TIME. THERE WAS NO PATIENT HARM OR CONSEQUENCE REPORTED AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17229049 ↗
• MalfunctionJun 27, 2023Break; Break

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE INITIAL REPORTER CONFIRMING THAT THIS EVENT OCCURRED DURING A SAMPLING OF A PANCREATIC TUMOR PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE CONDITION OF THE PATIENT WAS NOT IMPACTED BY THE FAILURE MODE. REPORTEDLY, THE STAFF WAS ABLE TO COMPLETE THE PROCEDURE. HOWEVER, HAS INITIALLY REPORTED, HE DID CONFIRM THAT TWO DIFFERENT EZSHOTS WERE USED AND BOTH FAILED. THEY WERE ABLE TO GET THE SAMPLE FROM BOTH PASSES OF EACH NEEDLE. THE PROCEDURE WAS NOT COMPLETED WITH A DIFFERENT DEVICE. THE PROCEDURE WAS NOT PROLONGED. THE NEEDLE HAD JUST FAILED UNEXPECTEDLY. THE PATIENT¿S ANESTHESIA OR SEDATION WAS NOT EXTENDED. THE PROCEDURE DID NOT NEED TO BE CANCELLED OR POSTPONED. THERE WAS NO MEDICAL INTERVENTION REQUIRED. THERE WERE NO OTHER DEVICES CONNECTED TO THE SUBJECT DEVICE WHEN THE FAILURE OCCURRED. THE PATIENT DEMOGRAPHICS ARE NOT AVAILABLE. THE PATIENT'S PRE-EXISTING CONDITIONS WERE A PANCREATIC TUMOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17208466 ↗
• InjuryMay 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATING NO OLYMPUS DEVICE MALFUNCTION DURING ANY PROCEDURE DESCRIBED IN THIS LITERATURE. THE CUSTOMER DOES NOT KNOW THE SERIAL/LOT NUMBERS OF THE DEVICE DUE TO THE DEVICE HAD BEEN DISPOSED AFTER PROCEDURE.

  Patient problems: Abrasion; Hematoma

  MAUDE report 17015033 ↗
• InjurySep 27, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PATIENTS WITH INFECTED WALLED-OFF NECROSIS: WHICH STENT TO CHOOSE?" LITERATURE SUMMARY: THIS SINGLE-CENTER RETROSPECTIVE STUDY OF A PROSPECTIVELY COLLECTED DATABASE OF ALL SYMPTOMATIC PANCREATIC FLUID COLLECTION (PFC) PATIENTS WHO UNDERWENT EUS-GUIDED DRAINAGE. AMONG 120 PATIENTS WITH PFC (108 WALLED-OFF NECROSIS (WON), 22 PSEUDOCYST) WHO UNDERWENT EUS-GUIDED DRAINAGE, THERE WAS NO DIFFERENCE IN OUTCOME PARAMETERS IN BIFLANGED METAL STENTS (BFMS) AND DOUBLE PIGTAIL PLASTIC STENTS (DPPS) GROUPS. AMONG PATIENTS WITH WON, CLINICAL SUCCESS WAS SIGNIFICANTLY HIGHER (96.2% VS. 81.8%, P=0.04), WITH SIGNIFICANTLY SHORTER HOSPITAL STAY (6 VS. 10 D) AND PROCEDURE DURATION (17.18 ± 4.6 VS. 43.6 ± 9.7 MIN, P<.0001) IN THE BFMS GROUP.. AMONG PATIENTS WITH INFECTED WON WITH/WITHOUT ORGAN FAILURE (OF), THE CLINICAL SUCCESS WAS SIGNIFICANTLY HIGHER (100% VS. 73.9%) IN BFMS COMPARED WITH DPPS GROUP. THE DURATION OF THE PROCEDURE WAS SIGNIFICANTLY LOWER (16.28 ± 4.4 VS. 44.39 ± 10.7, P<.0001) IN BFMS COMPARED WITH DPPS GROUP THIS STUDY CONCLUDED THAT EUS-GUIDED DRAINAGE OF WON USING BFMS SCORES OVER DPPS. IN

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15491883 ↗
• DeathSep 26, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "ENDOSCOPIC ULTRASOUND-GUIDED DRAINAGE OF PATIENTS WITH INFECTED WALLED-OFF NECROSIS: WHICH STENT TO CHOOSE?" LITERATURE SUMMARY: THIS SINGLE-CENTER RETROSPECTIVE STUDY OF A PROSPECTIVELY COLLECTED DATABASE OF ALL SYMPTOMATIC PANCREATIC FLUID COLLECTION (PFC) PATIENTS WHO UNDERWENT EUS-GUIDED DRAINAGE. AMONG 120 PATIENTS WITH PFC (108 WALLED-OFF NECROSIS (WON), 22 PSEUDOCYST) WHO UNDERWENT EUS-GUIDED DRAINAGE, THERE WAS NO DIFFERENCE IN OUTCOME PARAMETERS IN BIFLANGED METAL STENTS (BFMS) AND DOUBLE PIGTAIL PLASTIC STENTS (DPPS) GROUPS. AMONG PATIENTS WITH WON, CLINICAL SUCCESS WAS SIGNIFICANTLY HIGHER (96.2% VS. 81.8%, P=0.04), WITH SIGNIFICANTLY SHORTER HOSPITAL STAY (6 VS. 10 D) AND PROCEDURE DURATION (17.18 ± 4.6 VS. 43.6 ± 9.7 MIN, P<.0001) IN THE BFMS GROUP.. AMONG PATIENTS WITH INFECTED WON WITH/WITHOUT ORGAN FAILURE (OF), THE CLINICAL SUCCESS WAS SIGNIFICANTLY HIGHER (100% VS. 73.9%) IN BFMS COMPARED WITH DPPS GROUP. THE DURATION OF THE PROCEDURE WAS SIGNIFICANTLY LOWER (16.28 ± 4.4 VS. 44.39 ± 10.7, P<.0001) IN BFMS COMPARED WITH DPPS GROUP THIS STUDY CONCLUDED THAT EUS-GUIDED DRAINAGE OF WON USING BFMS SCORES OVER DPPS. IN

  Patient problems: Insufficient Information

  MAUDE report 15487560 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE:DISSEMINATED TUBERCULOSIS FOLLOWING INVASIVE PROCEDURES FOR PERIPANCREATIC LYMPH NODE TUBERCULOSIS WITH PORTAL VEIN OBSTRUCTION:A CASE REPORT." LITERATURE SUMMARY: PERIPANCREATIC TUBERCULOUS LYMPHADENOPATHY CAN MIMIC PANCREATIC CANCER ON IMAGING. THERE HAVE ONLY A FEW REPORTS ON VARICES FROM PORTAL VEIN OBSTRUCTION DUE TO ABDOMINAL TUBERCULOUS LYMPHADENOPATHY. IATROGENIC DISSEMINATED TUBERCULOSIS IS ALSO RARE. HEREIN, WE PRESENT A RARE CASE OF PERIPANCREATIC TUBERCULOUS LYMPHADENOPATHY WITH RUPTURED DUODENAL VARICES DUE TO PORTAL VEIN OBSTRUCTION. THE PATIENT PRESENTED TO OUR HOSPITAL WITH HEMATEMESIS. COMPUTED TOMOGRAPHY REVEALED A PERIPANCREATIC MASS. DUODENAL VARICES RUPTURE FROM PORTAL VEIN OBSTRUCTION DUE TO PANCREATIC CANCER WERE INITIALLY SUSPECTED. THE PATIENT UNDERWENT PORTAL VEIN STENTING FOR PORTAL VEIN OBSTRUCTION AND ENDOSCOPIC ULTRASOUND-GUIDED FINE-NEEDLE ASPIRATION FOR DIAGNOSIS, WHICH REVEALED GRANULOMAS INDICATIVE OF TUBERCULOSIS. THE PATIENT WAS DISCHARGED ONCE BECAUSE FINE-NEEDLE ASPIRATION DID NOT LEAD TO A DEFINITIVE DIAGNOSIS OF TUBERCULOSIS. SUBSEQUENTLY, HE DEVELOPED DISSEMINATED TUBERCULOSIS. PERIPANCREATIC TUBERCU

  Patient problems: Fever; Respiratory Tract Infection

  MAUDE report 15216746 ↗
• InjuryJun 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "EUS-GUIDED HEPATICOENTEROSTOMY WITH USING A DEDICATED PLASTIC STENT FOR THE BENIGN PANCREATICOBILIARY DISEASES: A SINGLE-CENTER STUDY OF A LARGE CASE SERIES". LITERATURE SUMMARY: THE AIM OF THE PRESENT STUDY WAS TO EVALUATE THE USABILITY OF DEDICATED PLASTIC STENTS FOR EUS-HES IN PATIENTS WITH BENIGN PANCREATICOBILIARY DISEASES. THE OVERALL TECHNICAL SUCCESS RATE OF EUS-HES WAS 92.9% (53/57). AMONG THE 4 CASES OF TECHNICAL FAILURE OF PLASTIC STENT PLACEMENT, A SEMS WAS PLACED IN 1; PERCUTANEOUS TRANSHEPATIC BILIARY DRAINAGE WAS PERFORMED IN 1; EUS-HES WAS REPERFORMED 1 WEEK LATER IN 1; AND OBSERVATIONAL MANAGEMENT WAS SELECTED IN 1 PATIENT. ADVERSE EVENTS ASSOCIATED WITH THE PROCEDURE WERE SEEN IN 15.7% (9/57) OF THE PATIENTS, NAMELY, BILIARY PERITONITIS IN 4, BLEEDING IN 2, CHOLECYSTITIS IN 2, AND PNEUMOPERITONEUM IN 1 PATIENT. EXCEPT FOR 1 PATIENT WHO REQUIRED BLOOD TRANSFUSION OWING TO BLEEDING AND 1 PATIENT WITH CHOLECYSTITIS WHO REQUIRED PERCUTANEOUS TRANSHEPATIC GALLBLADDER DRAINAGE, THE OTHER 7 PATIENTS WERE TREATED BY CONSERVATIVE THERAPY. ONE PATIENT WITH CLINICAL FAILURE REQUIRED ADDITIONAL INSERTION OF A NASOBILIARY DRAINAGE TUBE OWI

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Peritonitis; Unspecified Gastrointestinal Problem; Unspecified Hepatic or Biliary Problem

  MAUDE report 14757121 ↗