Long Clip HX-610-090L (REF N1085930)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04953170200373), received between Jun 11, 2019 and Nov 27, 2024 — classified as 14 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (4 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 22 most recent of 22 reports, in the reporter's own words as published by the FDA.

• InjuryNov 27, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  NO ADDITIONAL INFORMATION RECEIVED FROM CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20790599 ↗
• MalfunctionApr 5, 2024Separation Failure; Separation Failure

  IT WAS REPORTED THAT THE LONG CLIP THAT GRIPS THE PATIENT MUCOUS MEMBRANE COULD NOT BE DETACHED FROM THE APPLICATOR. THE ISSUE OCCURRED DURING A PERORAL ENDOSCOPIC MYOTOMY PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19055840 ↗
• InjuryDec 15, 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 "CAN UNDERWATER ENDOSCOPIC MUCOSAL RESECTION BE AN ALTERNATIVE TO CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS?" LITERATURE SUMMARY OBJECTIVES: UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) IS A SIMPLER PROCEDURE FOR SUPERFICIAL NON-AMPULLARY DUODENAL EPITHELIAL TUMORS (SYNDET) THAN CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (CEMR). THIS STUDY AIMED TO EVALUATE WHETHER CEMR CAN BE SUBSTITUTED BY UEMR FOR SNADET IN TERMS OF EFFECTIVENESS, SAFETY, AND LEARNING CURVE. METHODS: A TOTAL OF 157 CONSECUTIVE PATIENTS WITH 203 SNADETS <20 MM IN DIAMETER, INCLUDING 107 LESIONS RESECTED BY CEMR AND 96 LESIONS RESECTED BY UEMR, BETWEEN JANUARY 2019 AND MAY 2023, WERE RETROSPECTIVELY RECRUITED. THE TREATMENT OUTCOMES WERE COMPARED BETWEEN THE CEMR AND UEMR GROUPS. THE RISK FACTORS FOR INCOMPLETE RESECTION BY UEMR WERE ANALYZED USING UNIVARIATE AND MULTIVARIATE ANALYSES. LESIONS IN THE UEMR GROUP WERE DIVIDED CHRONOLOGICALLY INTO FIVE PERIODS; THEREAFTER, THE EN BLOC RESECTION RATE AND PROCEDURE TIME WERE COMPARED. RESULTS: NO SIGNIFICANT DIFFERENCES EXISTED BETWEEN THE CEMR AN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18335889 ↗
• InjuryOct 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REQUESTED CLARIFICATION OF THE REPORTED EVENT AND RECEIVED THE FOLLOWING TIMELINE FROM THE CUSTOMER: 1. A CLIP WAS INSERTED INTO THE RELEVANT SCOPE DURING THE PREVIOUS PROCEDURE. (THE CLIP WAS NOT USED IN THE PREVIOUS PROCEDURE). 2. THE CLIP AND CONNECTING ROD WERE NOT ATTACHED WHEN THE CLIP WAS REMOVED FROM THE SCOPE DURING THE PREVIOUS PROCEDURE. 3. WHEN THE SCOPE WAS REPROCESSED BY CLEANING, THE CLIP AND CONNECTING ROD WERE NOT FOUND. 4. THE CONNECTING ROD FELL OFF WHEN THE SCOPE WAS USED DURING THE SUBSEQUENT PROCEDURE. THE CLIP WAS MISSING. FURTHERMORE, ALTHOUGH THE CLIP HAD FALLEN OFF AND WAS MISSING, THERE WAS NO PLAN TO RETRIEVE IT FROM THE PATIENT¿S BODY. THE CLIP IS NOT COLLECTED EVEN WHEN IT IS USED INTENTIONALLY, AS IT IS BELIEVED TO BE EJECTED NATURALLY FROM THE PATIENT¿S BODY VIA STOOL. BOTH PATIENTS (IN PREVIOUS AND SUBSEQUENT PROCEDURE) WERE REPORTEDLY IN ¿MEDICAL CHECKUP¿ AND NOT HOSPITALIZED. IT WAS REPORTED THAT THERE WERE NO COMPLICATIONS.

  Patient problems: Foreign Body In Patient

  MAUDE report 17908942 ↗
• MalfunctionAug 29, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED THE LONG CLIP WAS SUCCESSFULLY ATTACHED TO THE SINGLE USE RELOADABLE CLIP APPLICATOR, PASSED THROUGH THE WORKING CHANNEL, AND OPENED DURING HEMOSTASIS IN A THERAPEUTIC PROCEDURE. WHEN TRYING TO CLOSE THE CLIP, THE CLIP DID NOT DETACH FROM THE CLIP APPLICATOR. THE INSIDE WIRE OF THE CLIP APPLICATOR BROKE FROM THE HANDLE, GOT LOOSE AND DID NOT RELEASE THE CLIP. THE PROBLEM WAS NOTED TO BE THE CLIP. THERE WAS A SMALL DELAY TO SWITCH TO A CLIP FROM ANOTHER MANUFACTURER TO COMPLETE THE PROCEDURE AND SOLVE SOME BLEEDING. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT. RELATED PATIENT IDENTIFIERS ARE (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17640002 ↗
• MalfunctionAug 28, 2023Mechanical Problem; Mechanical Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE LONG CLIP WAS NOT DETACHING FROM THE CLIP FIXING DEVICE WHEN TRYING TO CLOSE THE CLIP AND THE INSIDE WIRE CLIP APPLICATOR BREAKS FROM THE HANDLE AND GETS LOOSE AND DOES NOT RELEASE THE CLIP. THE ISSUE OCCURRED DURING PREPARATION FOR USE FOR A THERAPEUTIC PROCEDURE. THERE WERE NO REPORTS OF PATIENT HARM. RELATED PATIENT IDENTIFIER IS (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17638401 ↗
• MalfunctionJul 10, 2023Unsealed Device Packaging; Unsealed Device Packaging

  THE CUSTOMER REPORTED TO OLYMPUS THE LONG CLIP, CARTRIDGES WERE STORED AND USED, REMOVED FROM THE STERILIZED PACKS, FOR IMMEDIATE USE ON A DAILY BASIS. THE ISSUE OCCURRED DURING THE PROCEDURE. THE PROCEDURE WAS THERAPEUTIC. THE PROCEDURE WAS COMPLETED USING THE SAME SET OF EQUIPMENT. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17295548 ↗
• MalfunctionFeb 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED TO OLYMPUS THAT THE LONG CLIP COULD NOT BE LOADED INTO THE CLIP APPLIER DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. FIVE HEMOSTATIC CLIPS WERE USED, OF WHICH THE FIRST 2 FUNCTIONED CORRECTLY, WHEREAS THE LAST 3 CLIPS FAILED TO ACHIEVE THEIR FUNCTION. THE USER INTRODUCED THE AUTOCLAVABLE CLIPPER INTO THE BLUE ORIFICE, THEN PRECEDED WITH THE OPENING AND TRACTION NECESSARY FOR FITTING, BUT TWICE IT OPENED AND THEN MOVED LATERALLY TO THE CLIP, MAKING IT IMPOSSIBLE TO REMOVE FROM THE PACKAGING. ON THE THIRD ATTEMPT, THE CLIPPER LOCKED AND IT DETACHED ITSELF FROM THE TIP. THE PROCEDURE WAS DELAYED FOR 30 MINUTES AND REPORTEDLY RESULTED IN MODERATE BLEEDING. THE PROCEDURE WAS COMPLETED AND THERE WAS NO FURTHER REPORT OF PATIENT HARM OR INJURY DUE TO THE EVENT. NO ADDITIONAL INTERVENTIONS WERE PERFORMED AND THE PROCEDURE WAS COMPLETED. PATIENT IDENTIFIER (B)(6) FOR LONG CLIP #1 OF THE 3 CLIPS THAT FAILED IN THE EVENT. PATIENT IDENTIFIER (B)(6) FOR LONG CLIP #2 OF THE 3 CLIPS THAT FAILED IN THE EVENT. PATIENT IDENTIFIER (B)(6) FOR LONG CLIP #3 OF THE 3 CLIPS THAT FAILED IN THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16358772 ↗
• MalfunctionFeb 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED TO OLYMPUS THAT THE LONG CLIP COULD NOT BE LOADED INTO THE CLIP APPLIER DURING AN UNSPECIFIED THERAPEUTIC PROCEDURE. FIVE HEMOSTATIC CLIPS WERE USED, OF WHICH THE FIRST 2 FUNCTIONED CORRECTLY, WHEREAS THE LAST 3 CLIPS FAILED TO ACHIEVE THEIR FUNCTION. THE USER INTRODUCED THE AUTOCLAVABLE CLIPPER INTO THE BLUE ORIFICE, THEN PRECEDED WITH THE OPENING AND TRACTION NECESSARY FOR FITTING, BUT TWICE IT OPENED AND THEN MOVED LATERALLY TO THE CLIP, MAKING IT IMPOSSIBLE TO REMOVE FROM THE PACKAGING. ON THE THIRD ATTEMPT, THE CLIPPER LOCKED AND IT DETACHED ITSELF FROM THE TIP. THE PROCEDURE WAS DELAYED FOR 30 MINUTES AND REPORTEDLY RESULTED IN MODERATE BLEEDING. THE PROCEDURE WAS COMPLETED AND THERE WAS NO FURTHER REPORT OF PATIENT HARM OR INJURY DUE TO THE EVENT. NO ADDITIONAL INTERVENTIONS WERE PERFORMED AND THE PROCEDURE WAS COMPLETED. PATIENT IDENTIFIER (B)(6) FOR LONG CLIP #1 OF THE 3 CLIPS THAT FAILED IN THE EVENT. PATIENT IDENTIFIER (B)(6) FOR LONG CLIP #2 OF THE 3 CLIPS THAT FAILED IN THE EVENT. PATIENT IDENTIFIER (B)(6) FOR LONG CLIP #3 OF THE 3 CLIPS THAT FAILED IN THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16358186 ↗
• MalfunctionFeb 10, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE USER FACILITY REPORTED TO OLYMPUS THAT THE LONG CLIP COULD NOT BE LOADED INTO THE CLIP APPLIER DURING  AN UNSPECIFIED PROCEDURE. ON THE THIRD ATTEMPT, CLIP APPLIER BROKE AND WAS DETACHED. THERE WAS A 30 MINUTE DELAY TO OBTAIN ANOTHER DEVICE AND MODERATE BLEEDING NOTED. THE CASE WAS COMPLETED AND THERE WAS NO REPORT OF PATIENT HARM OR INJURY DUE TO THE EVENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16356227 ↗
• InjuryOct 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "CORRELATION BETWEEN ENDOSCOPIC RESECTION OUTCOMES AND ENDOSONOGRAPHIC FINDINGS IN GASTRIC TUMORS WITH MUSCULARIS PROPRIA ORIGIN." LITERATURE SUMMARY: THIS STUDY WAS AIMED TO DETERMINE THE CORRELATION BETWEEN ENDOSCOPIC RESECTION OUTCOMES AND ENDOSONOGRAPHIC FINDINGS IN GASTRIC TUMORS WITH MUSCULARIS PROPRIA ORIGIN. TOTAL 32 PATIENTS WERE INCLUDED; TUMORS LOCATED IN SUBMUCOSA (GROUP I, N=5), MUSCULARIS PROPRIA (GROUP II, N=14), AND TUMORS EXTENDED INTO THE OUTER CAVITY (GROUP III, N=13). IN TOTAL, FOUR PATIENTS EXPERIENCED PERFORATION WHICH OCCURRED IN ONE PATIENT IN GROUP I, ONE PATIENT IN GROUP II, AND TWO PATIENTS IN GROUP III AND LOCAL RECURRENCE OCCURRED IN TWO PATIENTS WITH INCOMPLETE EMD RESECTIONS. THIS STUDY CONCLUDED THAT PREPROCEDURAL EUS PREDICTED THE LAYER OF THE TUMOR ACCURATELY; HOWEVER, IT WAS LIMITED IN THE EVALUATION OF THE PATTERN OF INVASION. THEY FOUND THAT TUMORS THAT WERE DIAGNOSED AS GROWING OUTWARD ON EUS RARELY PENETRATED THE MUSCULARIS PROPRIA AND INVADED THE SUBSEROSAL LAYER UPON PATHOLOGICAL EXAMINATION. EUS HAS THE LIMITATIONS TO EVALUATE THE INVASION PATTERNS OF TUMORS USING EUS. TYPE OF ADVERSE EVENT

  Patient problems: Perforation

  MAUDE report 15653341 ↗
• InjurySep 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "GEL IMMERSION ENDOSCOPIC MUCOSAL RESECTION (EMR) FOR SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS MAY REDUCE PROCEDURE TIME COMPARED WITH UNDERWATER EMR (WITH VIDEO)". LITERATURE SUMMARY: THIS RETROSPECTIVE COHORT STUDY WAS AIMED TO EVALUATE THE ENDOSCOPIC OUTCOMES OF UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) AND GEL IMMERSION EMR (GIEMR). TOTAL 23 PATIENTS WERE INCLUDED IN THIS STUDY. GIEMR SIGNIFICANTLY REDUCED THE PROCEDURE TIME COMPARED WITH UEMR. THERE WAS NO SIGNIFICANT DIFFERENCE BETWEEN THE UEMR AND GIEMR GROUPS FOR EN BLOC RESECTION RATE AND R0 RESECTION RATE. THERE WAS ONE CASE OF INTRAOPERATIVE BLEEDING IN THE GIEMR GROUP AND ONE IN THE UEMR GROUP; BOTH OF WHICH WERE CONTROLLED WITH ENDOSCOPIC CLIPS. NO SERIOUS COMPLICATIONS WERE OBSERVED IN EITHER GROUP. THIS STUDY CONCLUDED THAT GIEMR WAS SAFE AND HAD GOOD THERAPEUTIC RESULTS FOR SNADETS AND SHOWED THE POTENTIAL TO ACCELERATE THE PROCEDURE TIME COMPARED WITH UEMR. THIS METHOD MAY BE PARTICULARLY USEFUL IN AREAS WHERE IMMERSION IN WATER IS DIFFICULT. INTRAOPERATIVE BLEEDING WAS DEFINED AS BLEEDING DURING OR IMMEDIATELY AFTER ENDOSCOPIC RESECTION. TYPE OF ADVE

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15501434 ↗
• InjuryJun 9, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED ¿CLINICAL AND ENDOSCOPIC FEATURES OF ACUTE HEMORRHAGIC RECTAL ULCER, PARTICULARLY IN REFRACTORY AND FATAL CASES.¿; PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ADVERSE EVENTS POTENTIALLY RELATED TOCF-HQ290I. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ADVERSE EVENTS POTENTIALLY RELATED TO FD-410LR. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS ADVERSE EVENTS POTENTIALLY RELATED TO HX-610-090L. BACKGROUND: ACUTE HEMORRHAGIC RECTAL ULCER (AHRU), CHARACTERIZED BY SUDDEN PAINLESS AND MASSIVE RECTAL BLEEDING IN BEDRIDDEN PATIENTS WITH SEVERE COMORBID ILLNESSES, IS INCREASINGLY BEING REPORTED IN ASIA, PARTICULARLY IN JAPAN. AIM: WE INVESTIGATED THE CLINICAL AND ENDOSCOPIC FEATURES OF AHRU AND THE RISK FACTORS ASSOCIATED WITH A REFRACTORY AND FATAL COURSE OF THIS CONDITION. METHOD: WE RETROSPECTIVELY REVIEWED THE RECORDS OF 44 PATIENTS WITH ENDOSCOPICALLY DOCUMENTED AHRU BETWEEN JANUARY 2016 AND DECEMBER 2017. WE RECORDED THE FOLLOWING DATA: (1) PATIENTS BACKGROUND. (2) ENDOSCOPIC FINDINGS AND HEMOSTASIS. (3) REBLEEDING AFTER PRIMARY HEMOSTATIC TREATMENT. (4)

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14644624 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED ¿PROPHYLACTIC CLIP CLOSURE FOR MUCOSAL DEFECTS IS ASSOCIATED WITH REDUCED ADVERSE EVENTS AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A PROPENSITY-SCORE MATCHING ANALYSIS¿ PATIENTS EXPERIENCED PERFORATION AND/OR BLEEDING EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-655Q. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS HX-610-090L. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS HX-202UR. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-H290Z1. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS PCF-Q260AI. STUDY BACKGROUND AND AIM IT IS UNCLEAR WHETHER PROPHYLACTIC ENDOSCOPIC CLOSURE AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) REDUCES THE RISK OF POSTOPERATIVE ADVERSE EVENTS DUE TO VARIABILITY IN LESION CHARACTERISTICS. THEREFORE, WE CONDUCTED A RETROSPECTIVE STUDY USING PROPENSITY SCORE MATCHING TO EVALUATE THE EFFICACY OF PROPHYLACTIC CLIP CLOSURE IN PREVENTING POSTOPERATIVE ADVERSE EVENTS AFTER COLORECTAL ESD. METHODS: THIS SINGLE-CENTER RETROSPECTIVE COHORT STUDY INCLUDED 219 COLORECTAL NEOPLASMS WHICH WERE REMOVED BY ESD. THE PATIENTS WERE ALLOCATED INTO THE CLOSURE AND

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14604972 ↗
• InjuryJun 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE USE OF ENDOSCOPIC CLIPPING IN PREVENTING DELAYED COMPLICATIONS AFTER ENDOSCOPIC RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL TUMORS". THIS RETROSPECTIVE COHORT STUDY DESCRIBED THE USE OF ENDOSCOPIC CLIPPING IN PREVENTING DELAYED COMPLICATIONS AFTER ENDOSCOPIC RESECTION FOR SUPERFICIAL NON-AMPULLARY DUODENAL TUMORS. PATIENTS WERE DIVIDED INTO 2 GROUPS: THE IMMEDIATE CLIPPING GROUP (ICG) AND THE NO CLIPPING GROUP (NCG). ENDOSCOPIC MUCOSAL RESECTION (EMR) AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WERE PERFORMED USING EITHER TWIN-CHANNEL MULTI-BENDING GASTROSCOPES (GIF-2TQ260M; OLYMPUS) OR CONVENTIONAL GASTROSCOPES (GIF-H260 OR GIF-HQ290; OLYMPUS). AN INITIAL INCISION WAS MADE OUTSIDE THE MARKS USING EITHER A DUAL KNIFE (KD-655; OLYMPUS) OR A HOOK KNIFE (KD-620LR; OLYMPUS). AFTER ER, THE MUCOSAL DEFECT WAS CLOSED USING CLIPS (HX-610-090L; OLYMPUS ) DELIVERED BY A CLIP-FIXING DEVICE (HX 110UR; OLYMPUS). A TOTAL OF 99 LESIONS FROM 99 PATIENTS WERE INCLUDED IN THIS STUDY. FIFTY-TWO PATIENTS WERE ALLOCATED INTO ICG AND 47 PATIENTS WERE ALLOCATED INTO NCG. DELAYED BLEEDING OCCURRED IN 1 PATIENT FROM ICG AND IN 8 PATIENTS FROM NCG. D

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14601590 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE, "ENDOSCOPIC SUBMUCOSAL DISSECTION AND TUNNELING PROCEDURES USING A NOVEL ALL-IN-ONE BIPOLAR DEVICE" BY ZAHEER NABI, ET AL.     THIS RETROSPECTIVE STUDY WAS AIMED TO EVALUATE THE USE OF A NEW MULTIFUNCTIONAL BIPOLAR DEVICE TO PERFORM PER-ORAL ENDOSCOPIC MYOTOMY (POEM), SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER), AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 10 PATIENTS HAD UNDERGONE THE PROCEDURES INCLUDED POEM (N = 7), STER FOR ESOPHAGEAL SUB-EPITHELIAL TUMOR (N = 1), ESD FOR RECTAL POLYP (N = 1), AND GASTRIC NEUROENDOCRINE TUMOR (N = 1). THE STUDY REPORTED THAT POEM WAS COMPLETED IN ALL PATIENTS AND THE PATIENTS WHO UNDERWENT STER AND ESD, EN-BLOC RESECTION WAS ACHIEVED IN ALL. THERE WERE NO REPORTED MAJOR ADVERSE EVENTS EXCEPT A FEW MILD TO MODERATE ADVERSE EVENTS. THE STUDY CONCLUDED THAT THE USE OF THE NEW BIPOLAR DEVICE FOR ESD WAS FEASIBLE AND SAFE. HOWEVER, THE FEASIBILITY AND SAFETY OF THE NOVEL BIPOLAR DEVICE FOR THESE PROCEDURES SHOULD BE EXPLORED FURTHER IN STUDIES WITH A LARGER SAMPLE SIZE. THE AUTHORS REPORTED USING 2 DIFFERENT OLYMPUS DEVICES ( GIF-1TH190 AND EZ CLIP, HX610 ¿ 090L) IN THEIR PROCEDURES A

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13839731 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE, "ENDOSCOPIC SUBMUCOSAL DISSECTION AND TUNNELING PROCEDURES USING A NOVEL ALL-IN-ONE BIPOLAR DEVICE" BY ZAHEER NABI, ET AL.     THIS RETROSPECTIVE STUDY WAS AIMED TO EVALUATE THE USE OF A NEW MULTIFUNCTIONAL BIPOLAR DEVICE TO PERFORM PER-ORAL ENDOSCOPIC MYOTOMY (POEM), SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER), AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 10 PATIENTS HAD UNDERGONE THE PROCEDURES INCLUDED POEM (N = 7), STER FOR ESOPHAGEAL SUB-EPITHELIAL TUMOR (N = 1), ESD FOR RECTAL POLYP (N = 1), AND GASTRIC NEUROENDOCRINE TUMOR (N = 1). THE STUDY REPORTED THAT POEM WAS COMPLETED IN ALL PATIENTS AND THE PATIENTS WHO UNDERWENT STER AND ESD, EN-BLOC RESECTION WAS ACHIEVED IN ALL. THERE WERE NO REPORTED MAJOR ADVERSE EVENTS EXCEPT A FEW MILD TO MODERATE ADVERSE EVENTS. THE STUDY CONCLUDED THAT THE USE OF THE NEW BIPOLAR DEVICE FOR ESD WAS FEASIBLE AND SAFE. HOWEVER, THE FEASIBILITY AND SAFETY OF THE NOVEL BIPOLAR DEVICE FOR THESE PROCEDURES SHOULD BE EXPLORED FURTHER IN STUDIES WITH A LARGER SAMPLE SIZE. THE AUTHORS REPORTED USING 2 DIFFERENT OLYMPUS DEVICES (GIF-1TH190 AND EZ CLIP, HX610 ¿ 090L) IN THEIR PROCEDURES AN

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13839721 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE, "ENDOSCOPIC SUBMUCOSAL DISSECTION AND TUNNELING PROCEDURES USING A NOVEL ALL-IN-ONE BIPOLAR DEVICE" BY ZAHEER NABI, ET AL.     THIS RETROSPECTIVE STUDY WAS AIMED TO EVALUATE THE USE OF A NEW MULTIFUNCTIONAL BIPOLAR DEVICE TO PERFORM PER-ORAL ENDOSCOPIC MYOTOMY (POEM), SUBMUCOSAL TUNNELING ENDOSCOPIC RESECTION (STER), AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 10 PATIENTS HAD UNDERGONE THE PROCEDURES INCLUDED POEM (N = 7), STER FOR ESOPHAGEAL SUB-EPITHELIAL TUMOR (N = 1), ESD FOR RECTAL POLYP (N = 1), AND GASTRIC NEUROENDOCRINE TUMOR (N = 1). THE STUDY REPORTED THAT POEM WAS COMPLETED IN ALL PATIENTS AND THE PATIENTS WHO UNDERWENT STER AND ESD, EN-BLOC RESECTION WAS ACHIEVED IN ALL. THERE WERE NO REPORTED MAJOR ADVERSE EVENTS EXCEPT A FEW MILD TO MODERATE ADVERSE EVENTS. THE STUDY CONCLUDED THAT THE USE OF THE NEW BIPOLAR DEVICE FOR ESD WAS FEASIBLE AND SAFE. HOWEVER, THE FEASIBILITY AND SAFETY OF THE NOVEL BIPOLAR DEVICE FOR THESE PROCEDURES SHOULD BE EXPLORED FURTHER IN STUDIES WITH A LARGER SAMPLE SIZE. THE AUTHORS REPORTED USING 2 DIFFERENT OLYMPUS DEVICES (GIF-1TH190 AND EZ CLIP, HX610 ¿ 090L) IN THEIR PROCEDURES AN

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13839707 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿PROPHYLACTIC CLIP APPLICATION FOR LARGE PEDUNCULATED POLYPS BEFORE SNARE POLYPECTOMY MAY DECREASE IMMEDIATE POST POLYPECTOMY BLEEDING,¿ PATIENTS EXPERIENCED IMMEDIATE OR DELAYED POST-POLYPECTOMY BLEEDING FOLLOWING PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT CF-Q260AI USED IN GROUP A AND B; CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT CF-H260AI USED IN GROUP A AND B; CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT HX-610-090L USED IN GROUP A. INTRODUCTION/STUDY AIM: ALTHOUGH PROPHYLACTIC CLIP APPLICATION BEFORE POLYPECTOMY MAY PREVENT POST POLYPECTOMY BLEEDING (PPB), THE USEFULNESS OF PROPHYLACTIC CLIPPING IN THE TREATMENT OF LARGE PEDUNCULATED POLYPS IS CONTROVERSIAL IN SOME PROSPECTIVE RANDOMIZED STUDIES. THIS STUDY WAS CONDUCTED TO EVALUATE THE EFFICACY OF PROPHYLACTIC CLIP APPLICATION AND TO INVESTIGATE THE PREDICTORS OF PPB IN LARGE PEDUNCULATED COLORECTAL POLYPS. STUDY METHOD: A TOTAL OF 137 PEDUNCULATED POLYPS (SIZE =1 CM) IN 116 PATIENTS WERE PROSPECTIVELY INCLUDED AND RANDOMIZED INTO GROUP A (WITH CLIPPING) AND GROUP B (WITHOUT CLIPPING), AND RESECTED. THE OCCURRENCES OF IMMEDIATE PPB (GRADED

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13827210 ↗
• InjuryMar 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS RECEIVED THE FOLLOWING LITERATURE ARTICLE: AN EXAMPLE OF CONSERVATIVE TREATMENT OF ESOPHAGEAL PERFORATION DUE TO OVERTUBE BY ENDOSCOPIC CLIP STITCHING BY SATORU OKABE, ET AL. THE STUDY EVALUATED A CASE OF ESOPHAGEAL PERFORATION CAUSED BY AN OVERTUBE THAT WAS TREATED CONSERVATIVELY, WITH SOME DISCUSSION OF THE LITERATURE. THE PATIENT WAS A (B)(6) WOMAN. DURING AN UPPER GASTROINTESTINAL ENDOSCOPY AT A PHYSICAL EXAMINATION, A LOW ELEVATED LESION WAS NOTED ON THE ANTERIOR WALL OF A SMALL CROSSBOW IN THE GASTRIC ANTRUM. A BIOPSY REVEALED AN ADENOMA, WHICH TENDED TO INCREASE IN SIZE, AND THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR ENDOSCOPIC TREATMENT. DURING ENDOSCOPIC TREATMENT, A FLEXIBLE OVERTUBE MADE BY SUMITOMO BAKELITE WAS INSERTED TO MARK THE LESION IN THE STOMACH. WHEN THE ENDOSCOPE WAS REMOVED TO REPLACE THE MAGNIFYING ENDOSCOPE WITH AN ENDOSCOPE FOR TREATMENT, THE TIP ATTACHMENT WAS CAUGHT ON THE LOWER END OF THE OVERTUBE, AND OBSERVATION OF THE SURROUNDING AREA REVEALED A LACERATION ON THE RIGHT WALL OF THE ESOPHAGUS AT THE LOWER END OF THE OVERTUBE, AND TISSUE OUTSIDE THE WALL WAS OBSERVED. THE OVERTUBE WAS REMOVED AS SOON AS POSSIBLE, AND THE PATIENT WAS OBSERVED T

  Patient problems: Unspecified Respiratory Problem

  MAUDE report 13826113 ↗
• InjuryNov 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) WAS INFORMED BY A HEALTH CARE PROFESSIONAL THAT A STRANGULATION ILEUS OCCURRED AFTER AN UNSPECIFIED PROCEDURE USING THE SUBJECT DEVICE (CLIP). THE USER FACILITY DOUBTED THAT CLIPPING NOT ONLY THE TISSUE OF SMALL INTESTINE BUT ALSO THE OTHER PARTS CAUSED THE STRANGULATION ILEUS. THE PATIENT NEEDED A SURGICAL INTERVENTION FOR THE STRANGULATION ILEUS.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12735917 ↗
• MalfunctionJun 11, 2019Difficult to Remove; Difficult to Remove

  WE RECEIVED THE FOLLOWING REPORT. THE CLIP FAILED TO DEPLOY (THE CLIP COULD NOT BE RELEASED). THE USER WITHDREW THE CLIP WITH A ROTATABLE CLIP FIXING DEVICE FROM THE PATIENT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8685861 ↗