Single Use Electrosurgical Knife KD-650 KD-650Q (UDI 04953170265778)Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 04953170265778), received between Nov 11, 2020 and Mar 12, 2025 — classified as 23 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 12, 2025Fracture; Fracture

  IT WAS REPORTED THAT THE ELECTROSURGICAL KNIFE WIRE FRACTURED AND FELL INTO THE PATIENT'S INTESTINAL LUMEN DURING A DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). THE DEVICE WAS NOT RETRIEVED AS IT WAS DETERMINED THAT IT WOULD PASS NATURALLY AND THE PROCEDURE WAS PROLONGED GREATER THAN THIRTY MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WERE NO REPORTS OF PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21583900 ↗
• MalfunctionNov 26, 2024Break; Break

  THE EVENT OCCURRED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20788067 ↗
• InjuryJun 24, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INTENDED PROCEDURE WAS A ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), AND THE SUBJECT DEVICE FELL OFF IN THE TRANSVERSE COLON. THE SUBJECT DEVICE WAS RETRIEVED WITH THE USE OF FORCEPS. THE PROCEDURE WAS NOT PROLONGED AND ADDITIONAL ANESTHESIA WAS NOT REQUIRED DUE TO THE DEVICE MALFUNCTION. THE PATIENT'S CURRENT CONDITION IS "GOOD" AND THE OUTCOME OF THE PROCEDURE WAS "EVERYTHING WAS GOOD." ADDITIONALLY, THE CUSTOMER REPORTED THAT THE POWER IS NORMAL SETTING OF THE HOSPITAL ELECTROSURGICAL UNIT, AND THERE IS NOTHING SPECIAL. THE DEVICE MALFUNCTION WAS OBSERVED DURING MUCOSAL INCISION - MUCOSAL DISSECTION STAGE OF THE PROCEDURE. THE REPORTED EVENT OCCURRED WITHIN 24 HOURS. NO SPECIFIC EVENTS OR ANOMALIES OCCUR AT THE TIME WHEN THE MISSING AREA WAS IDENTIFIED. NO CHANGES OR DEVIATIONS IN THE DEVICE OPERATION DURING THE OCCURRENCE OF THE MISSING AREA. NO INDICATION OF THERMAL INJURY TO THE TISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19601241 ↗
• InjuryMay 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "THE MANAGEMENT OF DIRECT ORAL ANTICOAGULANTS FOR COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION: A MULTICENTER OBSERVATIONAL STUDY" . LITERATURE SUMMARY. BACKGROUND: THERE IS A LACK OF REPORTS ON THE USE OF DIRECT ORAL ANTICOAGULANTS (DOACS) DURING COLORECTAL ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). AIMS: WE AIMED TO ASSESS WHETHER THE USE OF DOACS IS ASSOCIATED WITH A HIGHER INCIDENCE OF DELAYED BLEEDING (DB) AFTER ESD. METHODS: A TOTAL OF 4175 COLORECTAL NEOPLASMS IN 3515 PATIENTS WERE DISSECTED AT OUR HOSPITALS DURING STUDY PERIOD. WE INCLUDED 3909 LESIONS IN THE FINAL ANALYSIS. THE LESIONS WERE DIVIDED INTO TWO GROUPS: THE NO-AT GROUP (3668 NEOPLASMS) AND THE DOAC GROUP (241 NEOPLASMS). WE ALSO COMPARED THE DOAC WITHDRAWAL GROUP (154 NEOPLASMS) AND THE DOAC CONTINUATION GROUP (87 NEOPLASMS). RESULTS: AMONG THE 3909 LESIONS, DB OCCURRED IN A TOTAL OF 90 CASES (2.3%). THE RATE OF DB WAS 2.2% (82/3668), AND 3.3% (8/241), RESPECTIVELY. THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATE OF DB BETWEEN THE NO-AT GROUP AND THE DOAC GROUP. IN THE DOAC GROUP, THERE WERE NO SIGNIFICANT DIFFERENCES IN THE RATE OF DB BETWEEN THE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19394596 ↗
• InjuryApr 3, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INCIDENT OCCURRED DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. THE EVENT CAUSED A 15-MINUTE DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19032945 ↗
• 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 B

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

  MAUDE report 17818634 ↗
• 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 PERFORATION

  Patient problems: Bowel Perforation

  MAUDE report 17748366 ↗
• InjuryAug 8, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION OPERATION, THE KNIFE HEAD WAS BROKEN WHEN THE ATTACHMENT WAS POWERED ON. THE BROKEN PART FELL INTO THE PATIENT AND WAS SUCCESSFULLY REMOVED. THE USER FINISHED THE PROCEDURE WITH ANOTHER DEVICE, AND IT WAS NOT DELAYED MORE THAN 15 MINUTES. THERE WAS PATIENT INJURY AS A RESULT OF THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 17480324 ↗
• InjuryJul 5, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A USER FACILITY REPORTED TO OLYMPUS THAT WHILE USING THE SINGLE USE ELECTROSURGICAL KNIFE KD-650 DURING A ENDOSCOPIC SUBMUCOSAL DISSECTION FOR A GASTRIC STROMAL TUMOR, THE KNIFE HEAD WAS BROKEN AND FELL INTO THE STOMACH. IT WAS SUBSEQUENTLY REMOVED FROM THE STOMACH WITH A BIOPSY FORCEPS AFTER THE SURGERY. THE PHYSICIAN FINISHED THE CASE WITH A SIMILAR DEVICE. THERE WAS NO FURTHER HEALTH INJURY OR DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17262973 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR ANASTOMOTIC LESIONS AFTER COLORECTAL SURGERY." ABSTRACT BACKGROUND: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR ANASTOMOTIC LESIONS IS TECHNICALLY CHALLENGING. WE AIMED TO CHARACTERIZE THE CLINICOPATHOLOGIC CHARACTERISTICS, FEASIBILITY, AND EFFECTIVENESS OF ESD FOR ANASTOMOTIC LESIONS OF THE LOWER GASTROINTESTINAL TRACT. METHOD: WE RETROSPECTIVELY INVESTIGATED 55 PATIENTS WITH ANASTOMOTIC LESIONS OF THE LOWER GASTROINTESTINAL TRACT WHO UNDERWENT ESD FROM (B)(6) 2008 TO (B)(6) 2021. THE LESIONS INVOLVING ONE OR BOTH SIDES OF ANASTOMOSES WERE CLASSIFIED INTO THE UNILATERALLY INVOLVING ANASTOMOSIS (UIA) OR STRADDLING ANASTOMOSIS (SA) GROUP, RESPECTIVELY. WE COLLECTED CLINICOPATHOLOGICAL CHARACTERISTICS, PROCEDURE-RELATED PARAMETERS AND OUTCOMES, AND FOLLOW-UP DATA AND ANALYZED THE IMPACT OF ANASTOMOTIC INVOLVEMENT. RESULTS: THE MEAN AGE WAS 62.5 YEARS, AND THE MEDIAN PROCEDURE DURATION WAS 30 MIN. THE RATES OF EN BLOC RESECTION AND R0 RESECTION WERE 90.9% AND 85.5%, RESPECTIVELY. FOUR PATIENTS (7.3%) EXPERIENCED MAJOR ADVERSE EVENTS (AES). DURING A MEDIAN FOLLOW-UP OF 66 MONTHS (RANGE 14¿169), SEVEN

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

  MAUDE report 17176025 ↗
• MalfunctionJun 2, 2023Break; Break

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE KNIFE HEAD BROKE WHEN THE ATTACHMENT WAS USED WITH ELECTRICITY. THE REPORTED PROBLEM WAS FOUND DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION OPERATION. THE BROKEN PART FELL INTO THE PATIENT AND WAS BEEN REMOVED. USER FINISHED CASE WITH ANOTHER DEVICE, AND WAS NOT DELAYED MORE THAN 15 MINUTES. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17052226 ↗
• InjuryJun 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE KNIFE HEAD BROKE WHEN IT WAS POWERED ON. THE REPORTED PROBLEM WAS FOUND DURING A GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION. THE BROKEN PART FELL INTO THE PATIENT AND WAS BEEN REMOVED. THE USER FINISHED THE CASE WITH ANOTHER DEVICE AND WAS NOT DELAYED MORE THAN 15 MINUTES. THERE WAS NO HARM OR USER INJURY REPORTED DUE TO THE EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17042740 ↗
• 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 16865613 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT STRATEGY FOR GIANT 0-IS TUMORS EXHIBITING MUSCLE LAYER TRACTION IN OUR HOSPITAL". HUGE 0-IS (STEMLESS) TUMORS OF THE LARGE INTESTINE MAY EXHIBIT HIGH FIBROSIS AND MUSCLE TRACTION, AND ARE CONSIDERED TO BE HIGHLY DIFFICULT CASES OF ESD. IN THE PAST, MUSCLE LAYER TRACTION WAS ONE OF THE GUIDELINES FOR STOPPING ESD, BUT IT IS BECOMING A LESION THAT CAN BE OVERCOME BY THE PROGRESS OF ESD DEVICES INCLUDING TRACTION DEVICES AND VARIOUS TREATMENT METHODS SUCH AS THE TUNNEL METHOD AND POCKET-CREATION METHOD REPORTED BY YAMAMOTO, HAYASHI ET AL. IN OUR HOSPITAL, THE TUNNEL METHOD IS THE BASIC STRATEGY FOR HUGE 0-IS TYPE TUMORS, AND THE DOUBLE TUNNEL METHOD (DT METHOD) IS USED FOR CASES WITH SEVERE FIBROSIS AND MUSCLE LAYER TRACTION IN THE CENTER, AND THE OUTLINE OF THE METHOD IS EXPLAINED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: INTRAOPERATIVE PERFORATION - 1 PATIENT. DELAYED PERFORATION - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 10 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6): GIF-Q260J FOR A PATIENT IN CASE#(B)(4) WITH INTRAOPERATIVE PERFORATION. (B)(6): GIF-H290T FOR A PATIENT IN CASE#(B)(4) WITH INTRAOPE

  Patient problems: Perforation

  MAUDE report 16440343 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "TREATMENT STRATEGY FOR GIANT 0-IS TUMORS EXHIBITING MUSCLE LAYER TRACTION IN OUR HOSPITAL". HUGE 0-IS (STEMLESS) TUMORS OF THE LARGE INTESTINE MAY EXHIBIT HIGH FIBROSIS AND MUSCLE TRACTION, AND ARE CONSIDERED TO BE HIGHLY DIFFICULT CASES OF ESD. IN THE PAST, MUSCLE LAYER TRACTION WAS ONE OF THE GUIDELINES FOR STOPPING ESD, BUT IT IS BECOMING A LESION THAT CAN BE OVERCOME BY THE PROGRESS OF ESD DEVICES INCLUDING TRACTION DEVICES AND VARIOUS TREATMENT METHODS SUCH AS THE TUNNEL METHOD AND POCKET-CREATION METHOD REPORTED BY YAMAMOTO, HAYASHI ET AL. IN OUR HOSPITAL, THE TUNNEL METHOD IS THE BASIC STRATEGY FOR HUGE 0-IS TYPE TUMORS, AND THE DOUBLE TUNNEL METHOD (DT METHOD) IS USED FOR CASES WITH SEVERE FIBROSIS AND MUSCLE LAYER TRACTION IN THE CENTER, AND THE OUTLINE OF THE METHOD IS EXPLAINED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE PERFORATION - 1 PATIENT. DELAYED PERFORATION - 1 PATIENT. THIS LITERATURE ARTICLE REQUIRES 10 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: 1. (B)(6): GIF-Q260J FOR A PATIENT IN CASE#2 WITH INTRAOPERATIVE PERFORATION. 2. (B)(6): GIF-H290T FOR A PATIENT IN CASE#2 WITH INTRAOPERATI

  Patient problems: Perforation

  MAUDE report 16440060 ↗
• InjuryDec 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLED "EFFICACY OF THE POCKET-CREATION METHOD WITH A TRACTION DEVICE IN ENDOSCOPIC SUBMUCOSAL DISSECTION FOR RESIDUAL OR RECURRENT COLORECTAL LESIONS". LITERATURE SUMMARY; THIS STUDY AIMED TO COMPARE THE EFFICACY OF THE POCKET-CREATION METHOD (PCM) WITH A TRACTION DEVICE (TD) WITH THAT OF CONVENTIONAL ESD FOR RESIDUAL OR RECURRENT COLORECTAL LESIONS IN 72 PATIENTS. THE PRIMARY ENDPOINTS WERE EN BLOC RESECTION AND R0 RESECTION RATES. EN BLOC RESECTION WAS FEASIBLE IN ALL CASES WITH PCM WITH TD BUT FAILED IN 22% OF CASES OF CONVENTIONAL ESD. THE R0 RESECTION RATES FOR PCM WITH TD AND CONVENTIONAL ESD WERE 97% AND 66%, RESPECTIVELY. DISSECTION WAS SIGNIFICANTLY FASTER IN THE PCM WITH TD GROUP (13.0 VS. 7.9 MM2/MIN). THIS STUDY CONCLUDES THAT THE PCM WITH TD IS AN EFFECTIVE METHOD FOR TREATING RESIDUAL OR RECURRENT COLORECTAL LESIONS AFTER INCOMPLETE RESECTION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: [CONTROL GROUP]. PERFORATION-1 PATIENT . POST-PROCEDURAL BLEEDING- 1 PATIENT . [PCM WITH TD GROUP]. PERFORATION-1 PATIENT . POST-PROCEDURAL BLEEDING- 1 PATIENT. SINCE THE LITERATURE DESCRIBED "PCF-Q260J", WE SELECTED "PCF-Q260J

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16031158 ↗
• InjuryNov 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "COMPARISON OF ENDOSCOPIC SUBMUCOSAL RESECTION WITH LIGATION AND ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SMALL RECTAL NEUROENDOCRINE TUMORS: A MULTICENTER RETROSPECTIVE STUDY". LITERATURE SUMMARY OBJECTIVES: ENDOSCOPIC SUBMUCOSAL RESECTION WITH BAND LIGATION (ESMR-L) AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) ARE BOTH STANDARD ENDOSCOPIC RESECTION METHODS FOR RECTAL NEUROENDOCRINE TUMORS (NETS) <10 MM IN SIZE. HOWEVER, THERE IS NO DEFINITIVE CONSENSUS ON WHICH IS BETTER. HERE, WE COMPARED THE EFFICACY OF ESMR-L AND ESD FOR SMALL RECTAL NETS. METHODS: THIS WAS A MULTICENTER RETROSPECTIVE COHORT STUDY INCLUDING 205 PATIENTS WITH RECTAL NETS WHO UNDERWENT ESMR-L OR ESD. TREATMENT OUTCOMES WERE COMPARED BY UNIVARIATE ANALYSIS, MULTIVARIATE ANALYSIS, AND INVERSE PROBABILITY TREATMENT WEIGHTING (IPTW) USING PROPENSITY SCORES. SUBGROUP ANALYSIS EVALUATED THE IMPACT OF THE ENDOSCOPIST'S EXPERIENCE ON THE TECHNICAL OUTCOME. RESULTS: EIGHTY-NINE PATIENTS WERE TREATED BY ESMR-L AND 116 BY ESD. THE RO RESECTION RATE WAS NOT SIGNIFICANTLY DIFFERENT BETWEEN THE TWO (90% VS.92%, P = 0.73). THE PROCEDURE TIME OF ESMR-L WAS SIGNIFICANTL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15777131 ↗
• InjuryAug 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL PHARYNGEAL CARCINOMA IS EFFECTIVE AND SAFE". LITERATURE SUMMARY: THIS STUDY WAS AIMED TO EVALUATE RETROSPECTIVELY THE OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR SUPERFICIAL PHARYNGEAL CARCINOMAS. A TOTAL 27 PATIENTS WITH 30 LESIONS WERE TREATED BY ESD IN THIS STUDY. THE EN-BLOC AND COMPLETE RESECTION RATES WERE RESPECTIVELY 100% AND 93.3%. NO BLEEDING, PERFORATION, OR DYSPNEA DURING OR AFTER THE ESD PROCEDURE OCCURRED. THERE WAS 1 PATIENT WHO HAD POST-PROCEDURE RELATED PHARYNGEAL EDEMA AND CELLULITIS. THIS PATIENT WAS MANAGED WITH SUBSEQUENT CONSERVATIVE TREATMENT, INCLUDING FASTING, STERANE, AND INTRAVENOUS ANTIBIOTICS. THIS STUDY CONCLUDED THAT ESD IS EFFECTIVE AND SAFE FOR RESECTION OF SUPERFICIAL CARCINOMAS AT THE PHARYNX, WITH A HIGH COMPLETE RESECTION RATE AND FAVORABLE OUTCOMES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: PHARYNGEAL EDEMA (CELLULITIS) - 1 PATIENT. THIS ARTICLE INCLUDES THREE (3) REPORTS: (B)(6)/KD-650Q, (B)(6)/GIF-Q260, (B)(6)/GIF-H290. THIS REPORT IS 1 OF 3 (B)(6)/KD-650Q.

  Patient problems: Swelling/ Edema

  MAUDE report 15277350 ↗
• InjuryAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE: "LAPAROSCOPY-ASSISTED TRANSGASTRIC ENDOSCOPIC RETROGRADE CHOLANGIOPANCREATOGRAPHY IN BARIATRIC ROUX-EN-Y GASTRIC BYPASS PATIENTS." LITERATURE SUMMARY: OBJECTIVES: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) OF COLORECTAL LESIONS WAS INVENTED IN JAPAN, BUT POSTOPERATIVE MANAGEMENT INCLUDING HOSPITAL STAY HAS NOT BEEN RECONSIDERED DUE TO THE JAPANESE INSURANCE SYSTEM. TO EXPLORE APPROPRIATE POSTOPERATIVE MANAGEMENT AFTER COLORECTAL ESD, WE REVIEWED SHORT-TERM OUTCOMES AFTER ESD IN NON-SELECTED CONSECUTIVE PATIENTS. METHODS: PATIENTS WHO UNDERWENT COLORECTAL ESD FROM APRIL 2013 TO SEPTEMBER 2020 IN ONE INSTITUTION WERE REVIEWED. THE PRIMARY OUTCOME MEASURE WAS THE OCCURRENCE OF ADVERSE EVENTS STRATIFIED BY THE CLAVIEN-DINDO CLASSIFICATION WITH FIVE GRADES. A LOGISTIC REGRESSION MODEL WITH THE FIRTH PROCEDURE WAS APPLIED TO INVESTIGATE PREDICTORS OF SEVERE (GRADE III OR GREATER) ADVERSE EVENTS. RESULTS: A TOTAL OF 330 PATIENTS (FEMALE 40%, MALE 60%; MEDIAN 72 YEARS; IQR 65¿80 YEARS) WITH COLORECTAL LESIONS (MEDIAN 30 MM, IQR 23¿40 MM; COLON 77%, RECTUM 23%; SERRATED LESION 4%, ADENOMA 47%, MUCOSAL CANCER 30%, INVASIVE CANCER 18%) WAS EVALUATED. THE

  Patient problems: Abdominal Pain; Fever; Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15212092 ↗
• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON NOV. 8, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL NEOPLASMS IN PROXIMITY OR EXTENDING TO A DIVERTICULUM". IN THIS STUDY, 47 COLORECTAL LESIONS TREATED WITH ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BETWEEN JANUARY 2014 AND APRIL 2019 WERE INCLUDED. THE 47 SUBJECTS CONSISTED OF 27 MALE AND 20 FEMALE PATIENTS WITH A MEAN AGE OF 72.9 ± 9.8 YEARS. IN THE LITERATURE, IT WAS REPORTED THAT THE FOLLOWING. *DELAYED PERFORATION, DELAYED BLEEDING, FEVER, AND ABDOMINAL PAIN OCCURRED IN 1, 1, 4, AND 5 PATIENTS, RESPECTIVELY. *TWO DAYS AFTER THE ESD, A STRONG TENDERNESS WAS OBSERVED IN THE RIGHT LOWER ABDOMEN, AND CT REVEALED FREE AIR AROUND THE TREATMENT AREA. THE PATIENT WAS DIAGNOSED AS HAVING DEVELOPED POST OPERATIVE DELAYED PERFORATION, AND EMERGENCY SURGERY WAS PERFORMED. BASED ON THE AVAILABLE INFORMATION, REPORTED DELAYED PERFORATION, DELAYED BLEEDING, FEVER, ABDOMINAL PAIN WERE NOT REPORTED IN A DIRECT RELATIONSHIP WITH THE OLYMPUS PRODUCTS. HOWEVER, OMSC ASSUMES THAT THE DELAYED PERFORATION AND THE DELAYED BLEEDING MIGHT BE RELATED TO THE SUBJECT DEVICE SINCE THE SUBJECT DEVICE WAS USED FOR THE PROCEDURE.

  Patient problems: Abdominal Pain; Bowel Perforation

  MAUDE report 12921878 ↗
• InjuryDec 1, 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 "FACTORS PREDICTING TECHNICAL DIFFICULTIES DURING ENDOSCOPIC SUBMUCOSAL EXCAVATION FOR GASTRIC SUBMUCOSAL TUMOR". THE LITERATURE REPORTED THE RESULT OF GASTRIC SUBMUCOSAL TUMORS PATIENTS WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL EXCAVATION (ESE) PROCEDURE USING OLYMPUS KD-650Q AND ANOTHER DEVICE FROM APRIL 2011 TO DECEMBER 2019. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; (DELAYED BLEEDING (2 CASES). (FEVER (2 CASES). (CHEST PAIN (1 CASE). (MASSIVE INTRAOPERATIVE BLEEDING (1 CASE). THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE IN QUESTION. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. HOWEVER, THERE IS A STATEMENT IN THE LITERATURE AS FOLLOWS ONE PATIENT WITH "DELAYED BLEEDING" UNDERWENT ADDITIONAL ENDOSCOPIC TREATMENT. ONE PATIENT UNDERWENT LAPAROSCOPIC SURGERY BECAUSE OF "MASSIVE INTRAOPERATIVE BLEEDING." OMSC ASSUMES THAT "MASSIVE INTRAOPERATIVE BLEEDING" MIGHT BE RELATED TO THE SUBJECT DEVICE, AND THE SUBJECT DEVICE MIGHT BE CAUSED OR CONTRIBUTED

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 12913899 ↗
• InjuryDec 1, 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 "FACTORS PREDICTING TECHNICAL DIFFICULTIES DURING ENDOSCOPIC SUBMUCOSAL EXCAVATION FOR GASTRIC SUBMUCOSAL TUMOR." THE LITERATURE REPORTED THE RESULT OF GASTRIC SUBMUCOSAL TUMORS PATIENTS WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL EXCAVATION (ESE) PROCEDURE USING OLYMPUS KD-650Q AND ANOTHER DEVICE FROM APRIL 2011 TO DECEMBER 2019. IN THE LITERATURE, IT WAS REPORTED COMPLICATION AS FOLLOWS; (1) DELAYED BLEEDING (2 CASES). (2) FEVER (2 CASES). (3) CHEST PAIN (1 CASE). (4) MASSIVE INTRAOPERATIVE BLEEDING (1 CASE). THERE ARE NOT MENTIONED THAT THESE COMPLICATIONS WERE RELATED TO THE SUBJECT DEVICE IN QUESTION. BASED ON THE AVAILABLE INFORMATION, SPECIFIC INFORMATION ON THE SUBJECT DEVICE AND THE PATIENTS WERE NOT PROVIDED. THERE IS NO DESCRIPTION OF THE DEVICE'S MALFUNCTION. HOWEVER, THERE IS A STATEMENT IN THE LITERATURE AS FOLLOWS ONE PATIENT WITH "DELAYED BLEEDING" UNDERWENT ADDITIONAL ENDOSCOPIC TREATMENT. ONE PATIENT UNDERWENT LAPAROSCOPIC SURGERY BECAUSE OF "MASSIVE INTRAOPERATIVE BLEEDING." OMSC ASSUMES THAT "MASSIVE INTRAOPERATIVE BLEEDING" MIGHT BE RELATED TO THE SUBJECT DEVICE, AND THE SUBJECT DEVICE MIGHT BE CAUSED OR

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 12913879 ↗
• InjuryOct 4, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON SEPTEMBER 21, 2021, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE TITLED "RISK FACTORS FOR COMPLICATIONS AFTER ENDOSCOPIC TREATMENT IN CHINESE PATIENTS WITH EARLY ESOPHAGEAL CANCER AND PRECANCEROUS LESIONS". THE PURPOSE OF THIS LITERATURE WAS TO ANALYZE THE RISK FACTORS FOR COMPLICATIONS AFTER ENDOSCOPIC TREATMENT OF EARLY ESOPHAGEAL CANCER AND PRECANCEROUS LESIONS AND PROVIDES EVIDENCE FOR DEVELOPING PREVENTIVE MEASURES AGAINST THESE COMPLICATIONS. IN THE LITERATURE, IT WAS REPORTED AS FOLLOWS; A RETROSPECTIVE CHART REVIEW WAS PERFORMED TO IDENTIFY ALL PATIENTS WITH AN EARLY ESOPHAGEAL CANCER OR PRECANCEROUS LESIONS TREATED ENDOSCOPICALLY FROM JANUARY 2009 TO DECEMBER 2015 AT THE NATIONAL CANCER CENTER/CANCER HOSPITAL, CHINESE ACADEMY OF MEDICAL SCIENCES, AND PEKING UNION MEDICAL COLLEGE. A TOTAL OF 459 (368 MALE AND 91 FEMALE) PATIENTS WERE INCLUDED IN THE STUDY, WITH AN AVERAGE AGE OF 61 (35¿81) YEARS AND AN AVERAGE FOLLOW-UP OF 44.7 (19.3¿94.0) MONTHS. THE ESD WAS PERFORMED USING A DUAL KNIFE (KD-650Q) AND AN ENDOSCOPE (GIF-Q260J OR GIF-1T240 ) WITH A TRANSPARENT CAP ATTACHMENT (D-201-11804). AND EMR WAS PERFORMED USING A SNARE (SD-7P-1) AND AN ENDOSCOPE WITH

  Patient problems: Perforation of Esophagus

  MAUDE report 12573881 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "ESD WITH DOUBLE-BALLOON ENDOLUMINAL INTERVENTION PLATFORM VERSUS STANDARD ESD FOR MANAGEMENT OF COLON POLYPS" APPEARING IN THE AUG 2020 ISSUE OF ENDOSCOPY INTERNATIONAL, FOLLOWING A COLONOSCOPY WITH DOUBLE BALLOON ENDOLUMINAL INTERVENTION USING A PENTAX SINGLE-CHANNEL VIDEO ENDOSCOPE, AN OLYMPUS DISPOSABLE DISTAL CAP, AND AN OLYMPUS SINGLE USE ELECTROSURGICAL KNIFE, ONE PATIENT EXPERIENCED A BOWEL PERFORATION. NO INFORMATION WAS PROVIDED REGARDING ANY TREATMENT REQUIRED AS A RESULT OF THIS OCCURRENCE. THERE WAS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION.

  Patient problems: Bowel Perforation

  MAUDE report 11078153 ↗
• InjuryDec 28, 2020Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE ARTICLE TITLED "ESD WITH DOUBLE-BALLOON ENDOLUMINAL INTERVENTION PLATFORM VERSUS STANDARD ESD FOR MANAGEMENT OF COLON POLYPS" APPEARING IN THE AUG 2020 ISSUE OF ENDOSCOPY INTERNATIONAL, FOLLOWING A COLONOSCOPY WITH DOUBLE BALLOON ENDOLUMINAL INTERVENTION USING A PENTAX SINGLE-CHANNEL VIDEO ENDOSCOPE, AN OLYMPUS DISPOSABLE DISTAL CAP, AND AN OLYMPUS SINGLE USE ELECTROSURGICAL KNIFE, ONE PATIENT EXPERIENCED A BOWEL PERFORATION. NO INFORMATION WAS PROVIDED REGARDING ANY TREATMENT REQUIRED AS A RESULT OF THIS OCCURRENCE. THERE WAS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION.

  Patient problems: Bowel Perforation

  MAUDE report 11078069 ↗