Single Use Electrosurgical Knife KD-655 KD-655Q (UDI 04953170405631)Recalls & reported problems

Summary

The FDA's MAUDE database contains 22 adverse event reports that list this exact device (DI 04953170405631), received between Dec 23, 2021 and Sep 9, 2024 — classified as 19 injuries, 3 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.

• MalfunctionSep 9, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, DURING A THERAPEUTIC LOWER DIGESTIVE TRACT COLON ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, AN ENDOSCOPIC IMAGE CONFIRMED THAT THE DISK PART AT THE TIP OF THE KNIFE OF THE KD-655Q HAD COME OFF AND WAS MISSING. THE PROCEDURE WAS COMPLETED WITHOUT REPLACING THE DEVICE, AND THERE WAS NO HARM TO THE PATIENT¿S HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20169034 ↗
• MalfunctionAug 5, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED, THE ELECTROSURGICAL KNIFE FELL OFF (DURING THE CHECK AFTER THE PROCEDURE). THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19912152 ↗
• MalfunctionMay 7, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE SINGLE USE ELECTROSURGICAL KNIFE EXHIBITED A SITUATION WHERE THE TIP OF THE KNIFE HAD FALLEN OFF INSIDE THE BODY. THE TIP OF THE KNIFE WAS 3MM (SHARP). IT WAS UNCLEAR WHERE IN THE LARGE INTESTINE IT HAD FALLEN OFF AND THE DOCTOR CHOSE NOT TO RETRIEVE IT. THE ISSUE WAS FOUND DURING A THERAPEUTIC ENDOSCOPIC SPHINCTEROTOMY PROCEDURE AND THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19261090 ↗
• InjuryMar 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "V3-1 UTILITY AND SAFETY OF TECH KNIFE IN COLORECTAL ESD." LITERATURE SUMMARY ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF COLORECTAL TUMORS IS CONSIDERED A TECHNICALLY DIFFICULT AND TIME-CONSUMING PROCEDURE. IT HAS BEEN REPORTED THAT ADVANCES IN DEVICES CONTRIBUTE TO A REDUCTION IN THE COMPLICATION RATE, AND VARIOUS DEVICES HAVE BEEN DEVELOPED TO DATE TO IMPROVE THE SAFETY AND EFFICIENCY OF THE PROCEDURE. UNLIKE CONVENTIONAL TIP-BASED KNIVES, THE TECKNIFE (MICROTEC, INC.) CAN DELIVER FLUID FROM THE TIP OF THE KNIFE, ENABLING EFFICIENT INCISION AND DISSECTION, WHICH MAY RESULT IN A REDUCTION IN ESD PROCEDURE TIME. OBJECTIVE TO PROSPECTIVELY EVALUATE THE EFFICACY AND SAFETY OF THE MICROTEC KNIFE IN COLORECTAL ESD. METHODS (B)(4) COLORECTAL ESD CASES PERFORMED DURING A 6-MONTH PERIOD FROM (B)(6) 2023 WERE DIVIDED INTO 2 GROUPS: TK GROUP ((B)(4) CASES) USING A TECHKNIFE AND DK GROUP ((B)(4) CASES) USING DUALKNIFE J (OLYMPUS), AND COMPARED. THE PRIMARY ENDPOINT WAS DISSECTION SPEED, AND SECONDARY ENDPOINTS WERE ESD PROCEDURE TIME, THE NUMBER OF TIMES THE LOCAL INJECTION NEEDLE WAS INSERTED AND REMOVED, TOTAL LOCAL INJECTION VOLUME, AND INTR

  Patient problems: Perforation

  MAUDE report 18868702 ↗
• InjuryMar 8, 2024Adverse 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 EVENT DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT AN OLYMPUS DEVICE MALFUNCTION DID NOT OCCUR.

  Patient problems: Perforation

  MAUDE report 18865755 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "CLINICAL OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LARGE PEDUNCULATED COLORECTAL CARCINOMA: A RETROSPECTIVE MULTICENTER STUDY" COMPLETE EN-BLOC RESECTION OF PEDUNCULATED COLORECTAL CARCINOMA IS NECESSARY FOR A PROPER PATHOLOGICAL DIAGNOSIS. HOWEVER, DUE TO POOR VISIBILITY, LARGE PEDUNCULATED COLORECTAL CARCINOMAS ARE DIFFICULT TO SNARE AND RESECT EN-BLOC USING ENDOSCOPIC RESECTION OR POLYPECTOMY. ADDITIONALLY, THE BLEEDING RISK OF LARGE PEDUNCULATED COLORECTAL CARCINOMAS IS RELATIVELY HIGH. WE AIMED TO ASSESS THE FEASIBILITY AND SAFETY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR LARGE PEDUNCULATED COLORECTAL CARCINOMAS. WE CONDUCTED A RETROSPECTIVE MULTICENTER COHORT STUDY TO ASSESS 36 CONSECUTIVE PATIENTS WITH 36 LARGE PEDUNCULATED COLORECTAL CARCINOMAS WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION AND EVALUATED THE OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION. FURTHERMORE, PATIENTS WERE DIVIDED INTO TWO GROUPS ACCORDING TO THE PROCEDURE TIME, AND THE FACTORS RELATED TO THE PROCEDURE TIME WERE ASSESSED. FOUR PATIENTS EXPERIENCED SEVERE BLEEDING AND WAS CONTROLLED ENDOSCOPICALLY IN ALL PATIENTS. SEVERE BLEEDING WAS DEFINED AS BL

  Patient problems: Bowel Perforation; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17818753 ↗
• InjurySep 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE OLYMPUS REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE BROKE AT THE FIRST ENERGIZATION OF THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) AND FELL INTO THE BODY AND WAS RECOVERED. IT IS UNKNOWN WHERE IN THE BODY THE TIP FELL OFF OR HOW IT WAS RECOVERED. THERE WAS NO FURTHER MEDICAL OR SURGICAL INTERVENTION NEEDED AND NO PROCEDURAL DELAY. THERE WAS NO HEALTH HAZARD OR EFFECT ON THE PATIENT. THE PROCEDURE WAS COMPLETED BY REPLACING THE DEVICE WITH A SIMILAR ONE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17797826 ↗
• InjurySep 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "DIAGNOSTIC AND THERAPEUTIC STRATEGIES FOR COLORECTAL TUMOR WITH POSITIVE MUSCLE-RETRACTING SIGN." LITERATURE SUMMARY: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR COLORECTAL TUMORS WITH POSITIVE MUSCLE-RETRACTING (MR) SIGN OFTEN RESULTS IN INCOMPLETE RESECTION OR DISCONTINUATION OWING TO THE DIFFICULTY OF SUBMUCOSAL DISSECTION. THE PRESENT STUDY AIMED TO EVALUATE THE USEFULNESS OF ENDOSCOPIC ULTRASONOGRAPHY (EUS) IN DIAGNOSING THE MR SIGN AND PERFORMING ESD USING THE POCKET-CREATION METHOD (PCM). THIRTY-SIX CASES OF COLORECTAL TUMORS WITH POSITIVE MR SIGN DURING ESD BETWEEN JANUARY 2015 AND DECEMBER 2021 WERE RETROSPECTIVELY REVIEWED. CASES WERE DIVIDED INTO TWO GROUPS: 1) THE CONVENTIONAL METHOD (CM) GROUP, COMPRISING 29 CASES, AND 2) THE PCM GROUP WITH SEVEN CASES, IN WHICH PREOPERATIVE EUS AND ESD USING PCM WERE PERFORMED. TREATMENT OUTCOMES WERE COMPARED BETWEEN THE GROUPS. THE DIAGNOSTIC YIELD OF EUS FOR THE MR SIGN WAS EVALUATED AMONG LARGE SESSILE TUMORS >20 MM IN WHICH PREOPERATIVE EUS WAS PERFORMED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAOPERATIVE PERFORATION REQUIRING CLIPS TO CLOSE - 10 PATIENTS. DELAYED PERFORATIO

  Patient problems: Bowel Perforation

  MAUDE report 17748792 ↗
• InjuryJul 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMED PERFORATION HAPPENED DURING (ESD) ENDOSCOPIC SUBMUCOSAL DISSECTION KNIFE INCISION OF FIBROSIS TISSUE. IT IS NOT POSSIBLE TO SINGLE OUT THE CAUSE. IT WAS NOT A MALFUNCTION OF THE DEVICE. IT WAS A PERFORATION THAT IS USUALLY EXPERIENCE WITH DIFFICULT CASE.

  Patient problems: Perforation

  MAUDE report 17292773 ↗
• InjuryJun 20, 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, "HIGH PROFICIENCY OF ESOPHAGEAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WITH A "TUNNEL CLIP TRACTION" STRATEGY: A LARGE FRENCH MULTICENTRIC STUDY". LITERATURE SUMMARY: THIS STUDY AIMED TO ASSESS THE TECHNICAL RESULTS AND OUTCOMES OF A "TUNNEL CLIP" STRATEGY FOR ESOPHAGEAL ESD PROCEDURES PERFORMED BY LESS EXPERIENCED OPERATORS FOR THE TREATMENT OF SUPERFICIAL NEOPLASMS. A TOTAL 195 ESOPHAGEAL ESD PROCEDURES PERFORMED. THE PERCENTAGE OF RESECTED ESOPHAGEAL CIRCUMFERENCE IN SUPERFICIAL SQUAMOUS CELL CARCINOMAS (SSC) TENDED TO BE HIGHER THAN THAT IN HIGH-GRADE DYSPLASIA (HGD)/ADENOCARCINOMA (ADK) COMPLICATING BARRETT¿S ESOPHAGUS (BE). THE EN BLOC, R0 AND CURATIVE RESECTION RATES WERE BOTH HIGHER IN HGD/ADK COMPLICATING BE THAN IN SSCS. NO SIGNIFICANT DIFFERENCE WAS FOUND IN TERMS OF R0 RESECTION, RATE OF PERFORMING THE PROCEDURE, OR PERFORATION ACCORDING TO THE LOCATION OF THE LESION (UPPER THIRD, MIDDLE THIRD, LOWER THIRD, ESOPHAGOGASTRIC JUNCTION). THE ¿TUNNEL+CLIP¿ STRATEGY IS SAFE, AND ALLOWS TO ACHIEVE HIGH EN BLOC, R0 AND CURATIVE RESECTION RATES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS EVENT1: PERFORATION - 1 PA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Stenosis

  MAUDE report 17168091 ↗
• InjuryMay 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "CIRCUMFERENTIAL SUBMUCOSAL INCISION PRIOR TO ENDOSCOPIC MUCOSAL RESECTION VERSUS CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION FOR COLORECTAL LESIONS WITH ENDOSCOPIC FEATURES OF SESSILE SERRATED LESIONS". BACKGROUND: SESSILE SERRATED LESIONS (SSLS) ARE MORE PRONE TO INCOMPLETE RESECTION THAN CONVENTIONAL ADENOMAS. THIS STUDY EVALUATED WHETHER CIRCUMFERENTIAL SUBMUCOSAL INCISION PRIOR TO ENDOSCOPIC MUCOSAL RESECTION (CSI-EMR) CAN INCREASE THE RATE OF COMPLETE AND EN BLOC RESECTIONS OF COLORECTAL LESIONS WITH ENDOSCOPIC FEATURES OF SSL. METHODS RETROSPECTIVE ANALYSES AND PROPENSITY SCORE MATCHING WERE PERFORMED FOR THE RESECTION OF COLORECTAL LESIONS=10 MM WITH ENDOSCOPIC FEATURES OF SSL. RESULTS AFTER 1:1 RATIO MATCHING, 127 LESIONS IN THE CSI-EMR GROUP AND 127 IN THE EMR GROUP WERE SELECTED FOR ANALYSIS. THE MEDIAN SIZE OF THE LESIONS WAS 15 MM (IQR 12¿16) IN BOTH GROUPS. THERE WAS NO SIGNIFCANT DIFERENCE IN EITHER THE COMPLETE RESECTION RATE OR EN BLOC RESECTION RATE BETWEEN CSI-EMR AND EMR GROUPS (96.9% VS. 92.9%, P=0.155; 92.1% VS. 89.0%, P=0.391). BY CONTRAST, THE R0 RESECTION RATE WAS SIGNIFCANTLY HIGHER IN THE CSI-EMR GROUP THAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16865624 ↗
• InjuryMay 2, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED, "EFFICACY OF SINGLE-BALLOON OVERTUBE FOR ENDOSCOPIC SUBMUCOSAL DISSECTION IN THE PROXIMAL COLON: A PROPENSITY SCORE-MATCHED ANALYSIS". OBJECTIVES: A SINGLE-BALLOON OVERTUBE (SBO) CAN IMPROVE POOR SCOPE OPERABILITY DURING COLONIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD).WE AIMED TO EVALUATE THE CLINICAL USEFULNESS OF SBO FOR ESD IN THE PROXIMAL COLON AND THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. METHODS: A TOTAL OF 88 TUMORS LOCATED IN THE PROXIMAL COLON RESECTED BY BALLOON-ASSISTED ESD (BA-ESD) USING SBO AND 461 TUMORS RESECTED BY CONVENTIONAL ESD (C-ESD) BETWEEN (B)(6) 2015 AND (B)(6) 2020 WERE CONSIDERED. SEVENTY-EIGHT TUMORS EACH IN THE BA-ESD AND C-ESD GROUPS WERE MATCHED BY PROPENSITY SCORE MATCHING. ESD OUTCOMES WERE COMPARED BETWEEN THE GROUPS, AND A DECISION TREE ANALYSIS WAS PERFORMED TO EXPLORE THE PREDICTIVE FACTORS FOR CASES IN WHICH SBO IS USEFUL. RESULTS: THERE WERE NO SIGNIFICANT DIFFERENCES BETWEEN THE GROUPS IN THE MAJOR OUTCOMES SUCH AS EN BLOC RESECTION RATE (95% VS. 99%, P = 0.17), R0 RESECTION RATE (92% VS. 96%, P = 0.30), MEAN DISSECTION SPEED (16 MM2/MIN VS. 16 MM2/MIN,P = 0.53), AND INTRAOPERATIV

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16855947 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED TO OLYMPUS THAT THREE DAYS AFTER A THERAPEUTIC RECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE HAD BEEN PERFORMED, THE PATIENT CONDITION DETERIORATED AND WHEN A LARGE INTESTINE EXAMINATION WAS PERFORMED, IT WAS DISCOVERED THAT BLOOD HAD ACCUMULATED IN THE INTESTINAL MEMBRANE OF THE LARGE INTESTINE (LOCATION UNKNOWN). IT IS UNKNOWN WHETHER THIS WAS THE CAUSE OF THE DETERIORATION OF THE PATIENT'S CONDITION. NO FURTHER INFORMATION ABOUT ADDITIONAL TREATMENT WAS PROVIDED BUT THE PATIENT'S HOSPITALIZATION PERIOD WAS EXTENDED. THERE WAS NO REPORT OF A MALFUNCTION OF ANY OF THE MEDICAL DEVICES USED DURING THE PROCEDURE. THERE WERE NO REPORTS OF FURTHER PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. PATIENT IDENTIFIER (B)(6) REPORTS THE ELECTROSURGICAL GENERATOR USED IN THIS EVENT. PATIENT IDENTIFIER (B)(6) REPORTS THE SINGLE USE ELECTROSURGICAL KNIFE USED IN THIS EVENT. PATIENT IDENTIFIER (B)(6) REPORTS THE EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE USED IN THIS EVENT. PATIENT IDENTIFIER C23076360 REPORTS THE SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS USED IN THIS EVENT. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6).

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Insufficient Information

  MAUDE report 16440618 ↗
• InjuryFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED: THE WAS NO MALFUNCTION, NOR ADVERSE EVENT THAT OCCURRED DURING USE OF AN OLYMPUS DEVICE IN ANY OF THE PROCEDURES DESCRIBED IN THE ARTICLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16401674 ↗
• InjuryJul 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: WS1-7 TREATMENT RESULTS AND PRACTICE OF ESD FOR COLORECTAL TUMORS WITH MUSCLE LAYER TRACTION FINDINGS. [LITERATURE SUMMARY]: [BACKGROUND] MUSCLE LAYER TRACTION FINDINGS DURING COLORECTAL ESD (MUSCLE- IF RETRACTING SIGN; MR SIGN) IS OBSERVED, INCOMPLETE RESECTION OR DISCONTINUATION IS OFTEN REQUIRED DUE TO DIFFICULTY IN REMOVING THE SUBMUCOSAL LAYER. THIS TIME, WE REPORT THE TREATMENT RESULTS OF ESD FOR MR SIGN-POSITIVE COLORECTAL TUMORS, INCLUDING THE INGENUITY OF THE PROCEDURE. METHODS: OF THE LARGE INTESTINE ESD PERFORMED IN OUR DEPARTMENT FROM JANUARY 2015 TO DECEMBER 2021, 36 CASES (25 MALES, AVERAGE AGE 68 YEARS, AVERAGE TUMOR DIAMETER 43 MM, MACROSCOPIC TYPE) WERE POSITIVE FOR INTRAOPERATIVE MR SIGN. THE TREATMENT RESULTS (ESD COMPLETION RATE, BATCH RESECTION RATE, RO RESECTION RATE, INTRAOPERATIVE PERFORATION RATE, DELAYED PERFORATION RATE) WERE EXAMINED FOR 0-LS IN 18 CASES, 0-ISP IN 12 CASES, AND 0-ILA + LS IN 6 CASES. RECENTLY, AS A TECHNIQUE, WHEN MR SIGN IS DIAGNOSED BY PREOPERATIVE EUS, PEELING IS PERFORMED USING THE POCKET-CREATION METHOD, AND AN INCISION LINE IS ASSUMED FOR THE MUSCULAR LAYER TRACTION PART, AND THE DUAL KNIF

  Patient problems: Perforation

  MAUDE report 15065748 ↗
• 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 N

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14604937 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿EFFECTIVENESS OF COUNTER TRACTION USING A CLIP WITH A LOOPED THREAD FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: HX-610-135. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: KD-6555Q. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: CONVENTIONAL ESD (CESD)- GROUP (N-42) DEVICE: KD-6555Q. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: LOOPED THREAD (LT) GROUP (N-46)DEVICE: KD-6555Q. STUDY AIM: THE PRESENT STUDY WAS DESIGNED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF A NOVEL TRACTION METHOD. METHOD: IN (B)(6) 2018, WE INTRODUCED A COUNTER TRACTION METHOD USING A CLIP WITH A LT. WE TREATED 120 CONSECUTIVE COLORECTAL LESIONS IN 119 PATIENTS USING ESD BEFORE AND AFTER THE INTRODUCTION OF THIS TRACTION METHOD AT THE YODOGAWA CHRISTIAN HOSPITAL BETWEEN JANUARY 2017 AND APRIL 2019. ESD WAS INDICATED FOR LESIONS SIZED > 20 MM OR FOR THOSE SIZED < 20 MM THAT WERE EXPECTED TO HAVE FIBROSIS AND WERE DEEMED DIFFICULT TO RESECT EN BLOC WITH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14089786 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿EFFECTIVENESS OF COUNTER TRACTION USING A CLIP WITH A LOOPED THREAD FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: HX-610-135, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: KD-6555Q, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: CONVENTIONAL ESD (CESD)- GROUP (N-42) DEVICE: KD-6555Q, CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: LOOPED THREAD (LT) GROUP (N-46)DEVICE: KD-6555Q. STUDY AIM: THE PRESENT STUDY WAS DESIGNED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF A NOVEL TRACTION METHOD. METHOD: IN JUNE 2018, WE INTRODUCED A COUNTER TRACTION METHOD USING A CLIP WITH A LT. WE TREATED 120 CONSECUTIVE COLORECTAL LESIONS IN 119 PATIENTS USING ESD BEFORE AND AFTER THE INTRODUCTION OF THIS TRACTION METHOD AT THE YODOGAWA CHRISTIAN HOSPITAL BETWEEN JANUARY 2017 AND APRIL 2019. ESD WAS INDICATED FOR LESIONS SIZED > 20 MM OR FOR THOSE SIZED < 20 MM THAT WERE EXPECTED TO HAVE FIBROSIS AND WERE DEEMED DIFFICULT TO RESECT EN BLOC WITH TH

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14089742 ↗
• InjuryApr 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿EFFECTIVENESS OF COUNTER TRACTION USING A CLIP WITH A LOOPED THREAD FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: HX-610-135. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: TAC-ESD GROUP (N-19)-DEVICE: (B)(4). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: CONVENTIONAL ESD (CESD)- GROUP (N-42) DEVICE: (B)(4). CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS: LOOPED THREAD (LT) GROUP (N-46) DEVICE: (B)(4). STUDY AIM: THE PRESENT STUDY WAS DESIGNED TO EVALUATE THE SAFETY AND EFFECTIVENESS OF A NOVEL TRACTION METHOD. METHOD: IN (B)(6) 2018, WE INTRODUCED A COUNTER TRACTION METHOD USING A CLIP WITH A LT. WE TREATED 120 CONSECUTIVE COLORECTAL LESIONS IN 119 PATIENTS USING ESD BEFORE AND AFTER THE INTRODUCTION OF THIS TRACTION METHOD AT THE (B)(6) HOSPITAL BETWEEN (B)(6) 2017 AND (B)(6) 2019. ESD WAS INDICATED FOR LESIONS SIZED > 20 MM OR FOR THOSE SIZED < 20 MM THAT WERE EXPECTED TO HAVE FIBROSIS AND WERE DEEMED DIFFICULT TO RESECT EN BLOC WITH THE SNARE. ESD WA

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 14089651 ↗
• InjuryFeb 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN THE LITERATURE TITLED ¿FEVER AND ELECTROCOAGULATION SYNDROME AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION FOR PATIENTS WITH IMMUNOSUPPRESSANTS AND STEROIDS¿, PATIENTS EXPERIENCED ADVERSE EFFECTS DURING AND AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURES USING A SINGLE USE ELECTROSURGICAL KNIFE (KD-655). STUDY AIM: ASSESS THE RISK FACTORS OF POST-ESD FEVER AND POST-ESD COAGULATION SYNDROME (PECS), FOCUSING ON THE INVOLVEMENT OF IMMUNOSUPPRESSIVE DRUGS AND STEROIDS (IM). METHODS: THIS RETROSPECTIVE ANALYSIS OF 510 PATIENTS WHO UNDERWENT COLORECTAL ESD AT A SINGLE FACILITY OVER A FIVE-YEAR PERIOD. THE INCIDENCE RATE, CLINICAL OUTCOME, AND FACTORS ASSOCIATED WITH POST-ESD FEVER AND PECS WERE INVESTIGATED. RESULTS: POST-ESD FEVER AND PECS OCCURRED IN 63 PATIENTS (12.4%) AND 43 PATIENTS (8.4%), RESPECTIVELY. IN MULTIVARIATE ANALYSIS, THE AMERICAN SOCIETY OF ANESTHESIOLOGISTS PHYSICAL STATUS >3, THE USE OF IMMUNOSUPPRESSANTS OR PREDNISOLONE >5MG (IM GROUP), AND INJURY TO MUSCLE LAYER/PERFORATION WERE SIGNIFICANTLY ASSOCIATED WITH POST-ESD FEVER. IN PECS, IM GROUP, TUMORS LOCATED ON THE RIGHT SIDE, TREATMENT TIME >60 MIN, INJURY TO THE MUSCLE LAYER, AND MULTIPLE

  Patient problems: Abdominal Pain; Bowel Perforation; Fever

  MAUDE report 13486909 ↗
• InjuryJan 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON DECEMBER 22, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "HIGH TOTAL JOULE HEAT INCREASES THE RISK OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION ELECTROCOAGULATION SYNDROME AFTER COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION¿. THE PURPOSE OF THE LITERATURE WAS TO DETERMINE THE ASSOCIATION BETWEEN JOULE HEAT AND THE ONSET OF POST-ESD ELECTROCOAGULATION SYNDROME (PECS). THE ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS PERFORMED USING A WATER-JET SYSTEM COLONOSCOPE (PCF-Q260JI), A DUAL KNIFE (KD-655Q), A COAGRASPER (FD-411QR) AND AN ENDOSCOPIC CLIP (HX-610-090). A TRANSPARENT HOOD WAS MANUFACTURED BY NON-OLYMPUS. IN THE LITERATURE, IT WAS REPORTED 7 CASES OF INTRAOPERATIVE PERFORATION OR PENETRATION, 2 CASES OF INFECTIOUS DISEASE AFTER COLORECTAL ESD, 16 CASES OF PECS, 45 CASES OF SUBMUCOSAL FIBROSIS, AND 12 CASE OF ADDITIONAL SURGERY AFTER ESD. THERE WAS NO MORE INFORMATION OF 7 CASES OF INTRAOPERATIVE PERFORATION OR PENETRATION, 2 CASES OF AN INFECTIOUS DISEASE AFTER COLORECTAL ESD, 45 CASES OF SUBMUCOSAL FIBROSIS, AND 12 CASE OF ADDITIONAL SURGERY AFTER ESD. THE LITERATURE WROTE, ¿PECS IS A STATE OF TEMPORARY INFLAMMATION RESULTING FROM TRANSMISSION OF ELECTROCOAGULATION

  Patient problems: Perforation; Unspecified Infection

  MAUDE report 13161620 ↗
• InjuryDec 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "COMPARISON OF ENDOSCOPIC INJECTION OF BOTULINUM TOXIN AND STEROIDS IMMEDIATELY AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION TO PREVENT ESOPHAGEAL STRICTURE: A PROSPECTIVE COHORT STUDY". THE LITERATURE REPORTED THE RESULT OF 78 PATIENTS WITH EARLY ESOPHAGEAL CANCER WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING OLYMPUS HOOKKNIFE AND DUALKNIFE. IN THE LITERATURE, THE FOLLOWING COMPLICATIONS HAVE BEEN REPORTED TO HAVE OCCURRED. SMALL AMOUNT OF BLEEDING (6 CASES). MUSCULAR INJURY (24 CASES). DIED (2 CASES). INTRAOPERATIVE PERFORATION (3 CASES). ADDITIONAL TREATMENTS (7 CASES). STRICTURES (17 CASES). THE LITERATURE STATES AS FOLLOWS, "SEVEN PATIENTS WERE EXCLUDED FROM THE STUDY BECAUSE THEY RECEIVED ADDITIONAL TREATMENTS SUCH AS ADDITIONAL ESD (N=3), SURGERY (N=3) AND RADIATION THERAPY FOR THE NON-CURATIVE RESECTION BASED ON THE POSTOPERATIVE PATHOLOGIC DIAGNOSIS (N=1). TWO PATIENTS DIED OF NON-DIGESTIVE DISEASES AND THREE PATIENTS HAD INTRAOPERATIVE PERFORATION AND WERE ALSO EXCLUDED FROM OUR STUDY". BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT

  Patient problems: Perforation of Esophagus

  MAUDE report 13072779 ↗