Single Use Electrosurgical Knife KD-612 KD-612L (UDI 04953170325892)Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 04953170325892), received between Dec 15, 2021 and Aug 26, 2024 — classified as 21 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (7 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjuryAug 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED A LITERATURE TITLED "LONG- VS SHORT-SEGMENT BARRETT'S ESOPHAGUS-DERIVED ADENOCARCINOMA: CLINICAL FEATURES AND OUTCOMES OF ENDOSCOPIC SUBMUCOSAL DISSECTION". BACKGROUND THE INCIDENCE OF BARRETT¿S ESOPHAGEAL ADENOCARCINOMA (BEA) IS INCREASING, AND ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) HAS BEEN FREQUENTLY PERFORMED FOR ITS TREATMENT. HOWEVER, THE DIFFERENCES BETWEEN THE CHARACTERISTICS AND ESD OUTCOMES BETWEEN SHORT- AND LONG-SEGMENT BEA (SSBEA AND LSBEA, RESPECTIVELY) ARE UNCLEAR. WE COMPARED THE CLINICOPATHOLOGICAL CHARACTERISTICS AND SHORT- AND LONG-TERM OUTCOMES OF ESD BETWEEN BOTH GROUPS. METHODS WE RETROSPECTIVELY REVIEWED 155 SUPERFICIAL BEAS (106 SSBEAS AND 49 LSBEAS) TREATED WITH ESD IN 139 PATIENTS AND EXAMINED THEIR CLINICOPATHOLOGICAL FEATURES AND ESD OUTCOMES. SSBEA AND LSBEA WERE CLASSIFIED BASED ON WHETHER THE MAXIMUM LENGTH OF THE BACKGROUND MUCOSA OF BEA WAS < 3 CM OR = 3 CM, RESPECTIVELY. RESULTS COMPARED WITH SSBEA, LSBEA SHOWED SIGNIFICANTLY HIGHER PROPORTIONS OF CASES WITH THE MACROSCOPICALLY FLAT TYPE (36.7% VS. 5.7%, P < 0.001), LEFT WALL LOCATION (38.8% VS. 11.3%, P < 0.001), OVER HALF OF THE TUMOR CIRCUMFERENCE (20.4% VS. 1.9%, P < 0.001), AN

  Patient problems: Stenosis of the esophagus

  MAUDE report 20072067 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE LITERATURE TITLED "ASSESSMENT OF PREDICTIVE FACTORS ASSOCIATED WITH THE TECHNICAL DIFFICULTY OF ENDOSCOPIC SUBMUCOSAL DISSECTION FOR SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA: JAPANESE MULTICENTER RETROSPECTIVE STUDY". OBJECTIVES: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) IS PERFORMED FOR THE TREATMENT OF LESIONS WITH VARIED BACKGROUNDS AND FACTORS. HOWEVER, THE PREDICTIVE FACTORS ASSOCIATED WITH THE TECHNICAL DIFFICULTY OF ESD REMAIN UNKNOWN IN PATIENTS WITH VARIED LESIONS. THEREFORE, THIS STUDY AIMED TO IDENTIFY THE PREDICTIVE FACTORS ASSOCIATED WITH THE TECHNICAL DIFFICULTY OF ESD FOR ESCC USING A RETROSPECTIVE COHORT. METHODS: THIS MULTICENTER, RETROSPECTIVE STUDY WAS CONDUCTED IN 10 HOSPITALS IN JAPAN. CONSECUTIVE PATIENTS WHO UNDERWENT ESOPHAGEAL ESD BETWEEN (B)(6) 2013 AND (B)(6) 2019 WERE ENROLLED. LESIONS OF SUBEPITHELIAL TUMORS, ADENOCARCINOMA, AND ADENOMA WERE EXCLUDED. DIFFICULT LESIONS WERE DEFINED AS ESD REQUIRING A LONG PROCEDURE TIME (>120 MIN), PERFORATION DEVELOPMENT, PIECEMEAL RESECTION, OR DISCONTINUED ESD. IN THE PRESENT STUDY, THE CLINICAL FACTORS WERE ASSESSED TO IDENTIFY THE TEC

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19760025 ↗
• InjuryApr 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "UNTUTORED TRAINING PATHWAY TO ACHIEVE COMPETENCE IN ESOPHAGOGASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION IN A WESTERN CENTER." THE AIM OF THIS STUDY WAS TO ASSESS THE EFFICACY OF AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) UNSUPERVISED TRAINING MODEL FOR EXPERIENCED ENDOSCOPISTS. STEPWISE TRAINING INCLUDED A VISIT TO A HIGH-VOLUME CENTER, UNSUPERVISED TRAINING ON AN EX VIVO PORCINE MODEL, AND IN VIVO HUMAN UPPER GASTROINTESTINAL CASES WITH ANATOMIC PROGRESSION. PERFORMANCE MEASURES INCLUDED EN BLOC RESECTION, R0 RESECTION, ADVERSE EVENT RATES, AND OPERATING TIME. CIRCUMFERENTIAL INCISION WAS PERFORMED WITH A DUALKNIFE (KD-650Q OR KD-650L) AND DISSECTION WAS PERFORMED WITH A DUALKNIFE OR ITKNIFE (KD-611L OR KD-612). PERFORATION GASTRIC: 5 PATIENTS TOTAL 2 CASES WERE CONVERTED TO LAPAROSCOPIC SLEEVE GASTRECTOMY DUE TO PERFORATION. 1 CASE REQUIRED TOTAL GASTRECTOMY DUE TO SEVERE SUBMUCOSAL FIBROSIS. 2 GASTRIC CASES WERE CONVERTED TO SURGERY. ESOPHAGEAL: 3 PATIENTS TOTAL ALL MANAGED WITH CLIPS BLEEDING GASTRIC: 1 PATIENT REQUIRING HOSPITALIZATION. ESOPHAGEAL: 1 PATIENT REQUIRING HOSPITALIZATION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 19177359 ↗
• InjuryMar 26, 2024Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE PROCEDURE WAS A SURGICAL INCISION OF GASTRIC CARDIA MUCOSA. THE SUBJECT DEVICE WAS DISCARDED AFTER THE DEVICE MALFUNCTION AND THE OUTPUT SETTINGS ON THE ELECTROSURGICAL GENERATOR ARE UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18983988 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LONG-TERM OUTCOMES AFTER ENDOSCOPIC SUBMUCOSAL DISSECTION FOR COLORECTAL EPITHELIAL NEOPLASMS IN PATIENTS WITH SEVERE COMORBIDITIES". THE PURPOSE OF THE STUDY WAS TO EXAMINE THESE LONG-TERM OUTCOMES AND COMPARED THEM WITH THOSE IN PATIENTS WITH NON-SEVERE COMORBIDITIES. 231 PATIENTS WITH COLORECTAL EPITHELIAL NEOPLASMS (CENS) UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BETWEEN APRIL 2005 AND MARCH 2023. THE FOLLOWING EVENTS HAVE BEEN REPORTED IN THE LITERATURE FOR ALL 5 PATIENT IDENTIFIERS: EVENT 1: DELAYED BLEEDING (N=4). EVENT 2: PERFORATION (N=11). THIS LITERATURE ARTICLE REQUIRES 5 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : KD-655L. (B)(6) : KD-612L. (B)(6) : KD-625LR. (B)(6) : PCF-Q260AZI. (B)(6) : PCF-H290ZI. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6), MODEL KD-612L.

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

  MAUDE report 18434823 ↗
• InjuryOct 13, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ACCORDING TO THE REPORTER, THE EVENT DATE WAS SEPTEMBER 19, 2023. THE PROBE TIP FELL INTO THE PATIENTS STOMACH AND WAS RETRIEVED USING FORCEPS. THERE WAS NO NEED FOR UNPLANNED DIAGNOSTIC IMAGING TO LOCATE THE DEVICE OR CONFIRM IT WAS REMOVED. THE PROCEDURE WAS DELAYED BY 15 MINUTES WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA. THERE WAS NO HARM NOR INTERVENTION PERFORMED DUE THE DEVICE MALFUNCTION. THERE WERE NO ADDITIONAL DETAILS REGARDING THE PATIENT OR EVENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17929829 ↗
• InjuryAug 25, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE DEVICE FELL INTO THE GASTRIC PART OF THE BODY. THERE WAS NO UNPLANNED DIAGNOSTIC IMAGING NEEDED TO LOCATE THE DEVICE AS IT WAS REMOVED IMMEDIATELY AFTER FALLING. THERE WAS A FIVE MINUTE PROCEDURAL DELAY. THE DEVICE WAS INSPECTED BEFORE USE WITH NO ABNORMALITIES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17624059 ↗
• InjuryAug 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A USER FACILITY REPORTED TO OLYMPUS THAT AFTER AN USING THE SINGLE USE ELECTROSURGICAL KNIFE KD-612, THE CUTTER HEAD BROKE AND FELL INTO THE PATIENT'S BODY AND WAS SUBSEQUENTLY REMOVED. THE PROCEDURE WAS DELAYED DUE TO THIS, BUT NOT MORE THAN 15 MINUTES. THE CASE WAS FINISHED WITH ANOTHER DEVICE. NO PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17485063 ↗
• InjuryAug 8, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  A CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION PROCEDURE, THE CUTTER HEAD OF THE SINGLE USE ELECTROSURGICAL KNIFE KD-612 BROKE WHILE THE ATTACHMENT WAS POWERED ON. THE BROKEN PART FELL INTO THE PATIENT AND WAS SUBSEQUENTLY REMOVED. THIS CREATED A 15 MINUTE DELAY; THE SURGEON THEN FINISHED THE CASE WITH ANOTHER DEVICE. NO OTHER PATIENT INJURY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17485034 ↗
• InjuryAug 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED FROM THE AUTHOR, WHO CONFIRMED THAT THE ADVERSE EVENTS WERE NOT CAUSED BY AN OLYMPUS DEVICE AND THAT THERE WAS NO MALFUNCTION OF ANY OLYMPUS DEVICE.

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

  MAUDE report 17484752 ↗
• InjuryJun 1, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT THE KNIFE TIP WAS BROKEN WHEN THE ATTACHMENT WAS POWERED ON. THE REPORTED PROBLEM WAS FOUND DURING A ENDOSCOPIC SUBMUCOSAL DISSECTION OPERATION. THE BROKEN PART FELL INTO THE PATIENT AND WAS REMOVED. THE CASE WAS FINISHED 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 17039978 ↗
• InjuryMay 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS FURTHER RECEIVED INFORMATION FROM THE AUTHOR/PHYSICIAN THAT THE EVENTS DESCRIBE IN THE STUDY ARE CONSIDERED NORMAL FOR THE TECHNIQUE USED. FURTHERMORE, THE PHYSICIAN CONFIRMED THAT NO OLYMPUS DEVICE CONTRIBUTE TO THE EVENTS DESCRIBED IN THE STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16892598 ↗
• InjuryMar 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OBJECTIVES: LIMITED INFORMATION IS AVAILABLE ON THE EFFICACY AND SAFETY OF ENDOSCOPIC RESECTION (ER) OF GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE WHERE ER FOR GASTRIC TUMORS IS EXTREMELY POPULAR. METHODS: WE CONDUCTED THIS STUDY TO ELUCIDATE THE CURRENT SCENARIO OF ER FOR GASTRIC SMTS IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL AUGUST 2020. RESULTS: WE ENROLLED 117 PATIENTS WITH 118 LESIONS. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. THE MEAN ENDOSCOPIC TUMOR SIZE WAS 20±7.2 (8¿40)MM. THE GROWTH TYPE WAS PRIMARILY INTRALUMINAL (90%). THE MEAN RESECTION AND WOUND CLOSURE TIMES WERE 58±38 (RANGE, 12¿254) MIN AND 31±41 (RANGE, 3¿330)MIN, RESPECTIVELY. COMPLETE ER WAS ACHIEVED FOR 117 (99%) LESIONS. FULL-THICKNESS RESECTION RATE WAS 44%; HOWEVER, ONLY 12 (10%) PATIENTS REQUIRED ABDOMINAL PARACENTESIS FOR DECOMPRESSION. ENDOSCOPIC TREATMENTS WERE COMPLETED IN 115 (97%) LESIONS, WHILE THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICULTY IN DEFECT CLOSURE. GASTROINTESTINAL STROMAL

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16616516 ↗
• InjuryFeb 17, 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 "RADIAL INCISION AND CUTTING UNDER GEL IMMERSION AS A USEFUL METHOD FOR REFRACTORY ANASTOMOTIC STRICTURE." LITERATURE SUMMARY THIS CASE REPORT DISCUSSED ABOUT THE RADIAL INCISION AND CUTTING METHOD, IN WHICH THE STRICTURE IS INCISED AND THE SCAR TISSUE EXCISED IN THE 47 YEAR OLD MALE PATIENT WHO UNDERWENT LOW ANTERIOR RESECTION WITH CREATION OF A TEMPORARY COLOSTOMY FOR RECTAL CANCER. WHEN THE GEL WAS USED, THE BLEEDING POINT BECAME CLEAR, AND IT WAS POSSIBLE TO MAKE AN INCISION WITH A GOOD FIELD OF VIEW WHILE RECOGNIZING THE LINE OF THE MUSCLE LAYER EVEN WITH HEAVY BLEEDING. AFTER THE PROCEDURE, PASSAGE OF THE SCOPE WAS POSSIBLE. GEL IMMERSION ENDOSCOPY ENSURED A GOOD FIELD OF VIEW, EVEN IN SITUATIONS WITH HEAVY BLEEDING. RADIAL INCISION AND CUTTING UNDER GEL IMMERSION IS A SAFE AND EFFICIENT METHOD FOR THE TREATMENT OF REFRACTORY COLORECTAL ANASTOMOTIC STRICTURES. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS MULTIFOCAL HEMORRHAGE - 1 PATIENT. THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16400688 ↗
• InjuryNov 11, 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 "INGENUITY OF COLORECTAL ESD IN PATIENTS WITH FOLDS AND POOR OPERABILITY AND CLOSURE METHOD USING SB CLIPS FOR MUCOSAL DEFECTS AFTER ESD." PURPOSE: COLORECTAL ESD FOR LESIONS ON FOLDS IS GENERALLY DIFFICULT, BUT IN PATIENTS WITH POOR OPERABILITY, THE DIFFICULTY INCREASES AND THE PERFORATION RATE INCREASES. BY FIXING THE BLADE PART ON THE FOLD AND TWISTING THE SCOPE, THE IT KNIFE NANO CAN BE PEELED OFF BY CONTROLLING THE KNIFE IN THE DIRECTION AWAY FROM THE MUSCLE LAYER. EXAMINED GENDER. IN ADDITION, THE SUTURING METHOD IS IMPORTANT FOR ENSURING SAFETY IN HIGH-DIFFICULTY CASES. STUDY (1) AMONG 1360 CASES OF COLORECTAL ESD PERFORMED AT OUR HOSPITAL, 82 CASES WITH LESIONS ON FOLDS THAT WERE DIFFICULT TO OPERATE WERE TREATED WITH IT(+) GROUP USING IT KNIFE NANO IN COMBINATION WITH 49 CASES. THIRTY-THREE PATIENTS WERE CLASSIFIED INTO THE IT(1) GROUP, WHICH WAS NOT USED IN COMBINATION, AND THE CLINICOPATHOLOGICAL BACKGROUND AND TREATMENT RESULTS OF THE TWO GROUPS WERE COMPARED. STUDY (2) 95 CONSECUTIVE COLORECTAL ESD CASES PERFORMED AFTER MARCH 2020 WERE DIVIDED INTO GROUP A (SB CLIP) AND GROUP B (CONVENTIONAL CLIP) BY THE

  Patient problems: Perforation

  MAUDE report 15779096 ↗
• InjuryJul 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "LONG-TERM OUTCOMES OF ESOPHAGEAL SQUAMOUS CELL CARCINOMA WITH INVASION DEPTH OF PATHOLOGICAL T1A-MUSCULARIS MUCOSAE AND T1B-SUBMUCOSA BY ENDOSCOPIC RESECTION FOLLOWED BY APPROPRIATE ADDITIONAL TREATMENT". LITERATURE SUMMARY: ENDOSCOPIC RESECTION (ER) IS INDICATED FOR A WIDE RANGE OF SUPERFICIAL ESOPHAGEAL SQUAMOUS CELL CARCINOMAS (ESCCS)W. E EXAMINED THE LONG-TERM OUTCOMES IN PATIENTS WITH PATHOLOGICAL (P) INVASION OF ESCC INTO THE T1A-MUSCULARIS MUCOSAE (MM) AND T1B-SUBMUCOSA (SM) AFTER ER, FOR WHICH DATA ON PROGNOSIS ARE LIMITED. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS: EVENT 1:STENOSIS (MM 13.9%, SM1 10.7%, SM2 8.7%), EVENT 2:PERFORATION (MM 1.3%), EVENT 3:DELAYED BLEEDING (MM 0.6%), EVENT 4:LOCAL RECURRENCE(10), METASTATIC RECURRENCE(8), REGIONAL LN METASTATIC RECURRENCE(6), DISTANT METASTATIC RECURRENCE(3), LN METASTASIS DETECTED IN ESOPHAGECTOMY(4), OVERALL METASTASIS(12), EVENT 5:DEATH DUE TO ESCC(2), EVENT 6:DEATH DUE TO OTHER CAUSES(49). THE DEATHS HAVE BEEN DETERMINED TO BE NOT REPORTABLE. THIS ARTICLE INCLUDES 2 REPORTS: (B)(6) AE FOR KD-650L AND (B)(6) AE FOR KD-612L. THIS IS REPORT 2 OF 2 FOR (B)(6) AE FOR KD-612L.

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

  MAUDE report 14917218 ↗
• InjuryJun 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿LONG TERM CLINICAL OUTCOMES OF PATIENTS DIAGNOSED WITH PT1A MUSCULARIS MUCOSAE WITH LYMPHOVASCULAR INVASION OR PT1B AFTER ENDOSCOPIC RESECTION FOR CT1N0M0 ESOPHAGEAL SQUAMOUS CELL CARCINOMA,¿ PATIENTS EXPERIENCED ADVERSE EVENTS DURING/AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-2T240. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS GIF-Q20J. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-650L. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS KD-612L. BACKGROUND ENDOSCOPIC RESECTION (ER) IS PERFORMED FOR EARLY ESOPHAGEAL SQUAMOUS CELL CARCINOMA (ESCC) CASES. ADDITIONAL ESOPHAGECTOMY OR CHEMORADIOTHERAPY IS RECOMMENDED FOR NON-CURATIVE RESECTION (NCR) EVEN WITH PATHOLOGICALLY NEGATIVE VERTICAL MARGINS (PVM0); HOWEVER, THEIR CLINICAL OUTCOMES REMAIN UNKNOWN. WE EXAMINED THE LONG-TERM CLINICAL OUTCOMES OF NCR FOR ESCCS ACCORDING TO ADDITIONAL TREATMENTS. METHODS WE RETROSPECTIVELY ANALYZED THE DATA OF PATIENTS WHO UNDERWENT ER FOR CT1N0M0 ESCC BETWEEN 2009 AND 2017 JUDGED TO HAVE NCR, WHICH DEFINED WHEN PATHOLOGICALLY DIAGNOSED AS INVADING THE SUBMUCOSA (SM) OR MUSCULARIS MUCOSAE (MM) INVOLVING LYMPHOVASCULAR I

  Patient problems: Aspiration Pneumonitis; Perforation; Stenosis

  MAUDE report 14790624 ↗
• InjuryJan 20, 2022Material Separation; Material Separation

  THE CUSTOMER REPORTS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING A SINGLE USE ELECTROSURGICAL KNIFE KD-612, THE CERAMIC TIP FELL OFF WITHIN THE FIRST FEW MINUTES OF USE AND ONTO THE ANTERIOR WALL OF THE GASTRIC BODY. THE PATIENT EXPERIENCED A 2MM PERFORATION THROUGH THE MUSCULARIS PROPRIA (MP) LAYER. THE PATIENT WAS TREATED WITH TWO HEMOSTATIC CLIPS. THE PATIENT'S CURRENT CONDITION IS STABLE. THE GENERATOR USED IN THE CASE WAS ERBE, AND IT DID NOT MALFUNCTION IN ANY WAY. THE GENERATOR SETTING BEING USED IN THE CASE WAS: SWIFT COAG 30W.

  Patient problems: Perforation

  MAUDE report 13306940 ↗
• InjuryJan 20, 2022Detachment of Device or Device Component

  THE CUSTOMER REPORTS DURING AN ESOPHAGOGASTRODUODENOSCOPY (EGD) WITH ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING A SINGLE USE ELECTROSURGICAL KNIFE KD-612, THE CERAMIC TIP FELL OFF WITHIN THE FIRST FEW MINUTES OF USE AND ONTO THE ANTERIOR WALL OF THE GASTRIC BODY. THE PATIENT EXPERIENCED A 2MM PERFORATION THROUGH THE MUSCULARIS PROPRIA (MP) LAYER. THE PATIENT WAS TREATED WITH TWO HEMOSTATIC CLIPS. THE PATIENT'S CURRENT CONDITION IS STABLE. THE GENERATOR USED IN THE CASE WAS ERBE, AND IT DID NOT MALFUNCTION IN ANY WAY. THE GENERATOR SETTING BEING USED IN THE CASE WAS: SWIFT COAG 30W.

  Patient problems: Perforation

  MAUDE report 13306881 ↗
• InjuryDec 21, 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 "A CASE OF CONSERVATIVE TREATMENT FOR A LARGE PERFORATION DURING ESOPHAGEAL ESD WITH SUSPECTED PARTIAL ESOPHAGEAL STRICTURES". THE LITERATURE REPORTED THE RESULT OF A PATIENT WITH EARLY-STAGE ESOPHAGEAL CANCER WHO UNDERWENT ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE USING OLYMPUS DUAL KNIFE J AND IT KNIFE NANO. IN THE LITERATURE, THE FOLLOWING PERFORATION HAVE BEEN REPORTED TO HAVE OCCURRED. "AFTER MARKING THE PERIPHERY OF THE LESION WITH A DUAL KNIFE J, THE DISSECTION WAS STARTED FROM THE MOUTH SIDE. DURING THE DISSECTION, THE ENDO TRACK WAS USED FOR TRACTION, BUT SUDDENLY A HUGE LOSS OF MUSCLE LAYER AND FIBROUS STRUCTURES WERE OBSERVED. THE PERFORATION WAS SUTURED USING CLIPS AND INDWELLING SNARES, AND THE PERFORATION WAS FILLED WITH PGA SHEET AND FIBRIN GLUE. A CT SCAN AFTER THE PROCEDURE SHOWED MEDIASTINAL EMPHYSEMA AROUND THE PERFORATION AND ACROSS THE DIAPHRAGM. ON THE NEXT DAY, THE MEDIASTINAL EMPHYSEMA WORSENED AND SUBCUTANEOUS EMPHYSEMA OF THE ANTERIOR CHEST AND RIGHT PLEURAL EFFUSION APPEARED, AND THE INFLAMMATORY RESPONSE INCREASED WITH WBC 13800 AND CRP 17.LMG/DL. AFTER DISCUSSION WITH THE SURGEON,

  Patient problems: Perforation of Esophagus; Pleural Effusion; Pulmonary Emphysema

  MAUDE report 13057646 ↗
• InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON (B)(6), OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED THE LITERATURE "A NOMOGRAM FOR PREDICTING LAPAROSCOPIC AND ENDOSCOPIC COOPERATIVE SURGERY DURING THE ENDOSCOPIC RESECTION OF SUBEPITHELIAL TUMORS OF THE UPPER GASTROINTESTINAL TRACT¿. THE PURPOSE OF THE LITERATURE WAS TO ANALYZE THE OUTCOME OF ENDOSCOPIC RESECTION FOR SUBEPITHELIAL TUMORS (SETS) AND DEVELOP A PREDICTION MODEL FOR THE NEED FOR LAPAROSCOPIC AND ENDOSCOPIC COOPERATIVE SURGERY (LECS) DURING THE PROCEDURE. THE EQUIPMENT USED FOR ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) INCLUDED OLYMPUS ENDOSCOPES (GIF-H260Z AND GIF-2TQ260M) WITH DUAL KNIFE (KD-650L; OLYMPUS MEDICAL SYSTEMS CORP., (B)(6)), IT KNIFE-2 (KD-612L; OLYMPUS), AND AN ELECTROSURGICAL GENERATOR (ESG-100; OLYMPUS). A CO2 INSUFFLATION SYSTEM (UCR; OLYMPUS) WAS USED TO REDUCE PATIENT DISCOMFORT DURING THE ESD PROCEDURE. IT WAS REPORTED THAT PREOPERATIVELY, THE AUTHORS CONSULTED THE GENERAL SURGEON ROUTINELY FOR THE POSSIBLE NEED FOR LECS IN CASES WHERE PERFORATION OCCURRED (WITH PERFORATION, THE ENDOSCOPIST COULD NOT SEAL THE SITE WITH CLIPS BECAUSE OF FULL-THICKNESS RESECTION) OR THE TUMOR WAS DEEMED UNSUITABLE FOR COMPLETE RESECTION VIA ENDOSCOPY ALONE. IN CAS

  Patient problems: Abdominal Pain; Perforation

  MAUDE report 13008093 ↗