Single Use Electrosurgical Knife KD-612Recalls & reported problems across all models

We found 3 models of Single Use Electrosurgical Knife KD-612 by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 33 adverse event reports in the FDA's MAUDE database, received between Dec 15, 2021 and Oct 2, 2024 — classified as 1 death, 29 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Break” (9 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Single Use Electrosurgical Knife KD-612 problems

Single Use Electrosurgical Knife KD-612 models

3 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Single Use Electrosurgical Knife KD-612 KD-612L

  Unit, electrosurgical, endoscopic (with or without accessories)
  21 reports
• Single Use Electrosurgical Knife KD-612 KD-612L

  Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
  1 death9 reports
• Single Use Electrosurgical Knife KD-612 KD-612U

  Unit, electrosurgical, endoscopic (with or without accessories)
  3 reports

Recent Single Use Electrosurgical Knife KD-612 adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "THE DERIVATION AND EXTERNAL VALIDATION OF A FIBROSIS RISK MODEL FOR COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION." LITERATURE SUMMARY: THIS STUDY AIMED TO DERIVE AND VALIDATE A PREDICTION MODEL TO DETERMINE THE PREOPERATIVE DEGREE OF SUBMUCOSAL FIBROSIS IN COLORECTAL TUMOURS UNDERGOING ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD). A TOTAL OF 309 PATIENTS (AGE: 68 ± 10.9 YEARS) UNDERWENT COLORECTAL ESD. NO FIBROSIS (F0), F1 FIBROSIS, AND F2 FIBROSIS WERE REPORTED IN 196 (63.4%), 70 (22.6%), AND 43 (13.9%) CASES, RESPECTIVELY. COMPLICATIONS WERE EXPERIENCED IN 20 (6.4%) RESECTIONS, 10 (3.2%) BEING PERFORATIONS AND 10 (3.2%) SIGNIFICANT BLEEDING. AFTER DISSECTION, HEMOSTASIS WAS PERFORMED WITH A COAGRASPER WHENEVER NECESSARY, AND DEFECTS WERE CLOSED WITH THROUGH-THE-SCOPE CLIPS. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. PERFORATION/10 PATIENTS. SIGNIFICANT BLEEDING/10 PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 20351619 ↗
• 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 ↗
• MalfunctionMar 5, 2024Break; Break

  IT WAS REPORTED, THAT DURING THE ESD (ENDOSCOPIC SUBMUCOSAL DISSECTION) PROCEDURE, THE ELECTROSURGICAL KNIFE KD-612 INSULATING CHIP AT THE TIP FELL OFF INSIDE THE BODY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED BY REPLACING IT WITH A NEW PRODUCT. THERE WERE NO REPORTS OF PATIENT HARM OR INJURY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18841276 ↗
• MalfunctionFeb 20, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE FELL INTO THE PATIENT'S BODY. THE ISSUE OCCURRED ABOUT 30 MINUTES AFTER THE START OF A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. A SIMILAR DEVICE WAS USED TO COMPLETE THE PROCEDURE. THE PHYSICIAN INDICATED THE FALLEN PART WOULD BE DISCHARGED NATURALLY. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18736995 ↗
• InjuryFeb 7, 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 "ENDOSCOPIC RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER RETROSPECTIVE STUDY (WITH A VIDEO)." THE STUDY WAS TO ELUCIDATE THE CURRENT SCENARIO OF ENDOSCOPIC RESECTION (ER) FOR GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL (B)(6) 2020. THERE WAS 117 PATIENTS WITH 118 LESIONS ENROLLED IN THE STUDY. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. ACCORDING TO THE JAPANESE GUIDELINES FOR THE TREATMENT OF GASTROINTESTINAL STROMAL TUMORS (GISTS) THE FOLLOWING ARE INDICATED FOR RESECTION: 1) HISTOLOGICALLY DIAGNOSED AS GIST. 2) >5 CM. 3) TENDENCY TO ENLARGE. 4) MALIGNANT FINDINGS. IT KNIFE, IT KNIFE 2, OR IT KNIFE NANO (KD-610L, KD-611L, OR KD-612, OLYMPUS, TOKYO, JAPAN) AND NEEDLE SCALPELS WERE USED IN 71 CASES (61%). ADVERSE EVENTS: TWO PATIENTS HAD POSTOPERATIVE BLEEDING THAT WAS STOPPED ENDOSCOPICALLY AND ONE OF THEM REQUIRED BLOOD TRANSFUSION. THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICUL

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Pneumoperitoneum

  MAUDE report 18660289 ↗
• DeathFeb 7, 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 "ENDOSCOPIC RESECTION FOR GASTRIC SUBMUCOSAL TUMORS: JAPANESE MULTICENTER RETROSPECTIVE STUDY (WITH A VIDEO)." THE STUDY WAS TO ELUCIDATE THE CURRENT SCENARIO OF ENDOSCOPIC RESECTION (ER) FOR GASTRIC SUBMUCOSAL TUMORS (SMTS) IN JAPANESE ENDOSCOPIC PRACTICE. PATIENTS (FROM 12 INSTITUTIONS) WITH GASTRIC SMTS WHO UNDERWENT ER WERE ENROLLED FROM THE FIRST CASE UNTIL AUGUST 2020. THERE WAS 117 PATIENTS WITH 118 LESIONS ENROLLED IN THE STUDY. THE NUMBER OF PATIENTS WHO UNDERWENT ER INCREASED OVER THE YEARS. ACCORDING TO THE JAPANESE GUIDELINES FOR THE TREATMENT OF GASTROINTESTINAL STROMAL TUMORS (GISTS) THE FOLLOWING ARE INDICATED FOR RESECTION: 1) HISTOLOGICALLY DIAGNOSED AS GIST 2) >5 CM 3) TENDENCY TO ENLARGE 4) MALIGNANT FINDINGS. IT KNIFE, IT KNIFE 2, OR IT KNIFE NANO (KD-610L, KD-611L, OR KD-612, OLYMPUS, TOKYO, JAPAN) AND NEEDLE SCALPELS WERE USED IN 71 CASES (61%). ADVERSE EVENTS: TWO PATIENTS HAD POSTOPERATIVE BLEEDING THAT WAS STOPPED ENDOSCOPICALLY AND ONE OF THEM REQUIRED BLOOD TRANSFUSION. THREE LESIONS REQUIRED CONVERSIONS TO LAPAROSCOPIC SURGERY DUE TO LUMINAL COLLAPSE, UNCONTROLLED BLEEDING, AND DIFFICULTY

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18660227 ↗
• MalfunctionFeb 6, 2024Break; Break

  THE CUSTOMER REPORTED THE TIP OF THE ELECTROSURGICAL KNIFE FELL OFF. THE ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE. THE FALLEN PART WAS COLLECTED AND THE PROCEDURE WAS COMPLETED USING A SIMILAR DEVICE. THERE WAS NO REPORTED PATIENT HARM OR IMPACT DUE TO THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18648642 ↗
• 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 ↗
• InjuryNov 13, 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 "BALLOON-ASSISTED ENTEROSCOPY-BASED ENDOSCOPIC STRICTUROTOMY FOR DEEP SMALL BOWEL STRICTURES FROM CROHN'S DISEASE: FIRST COHORT STUDY OF A NOVEL APPROACH". LITERATURE SUMMARY: BACKGROUND: THERE IS LITTLE DATA ON THE ROLE OF ENDOSCOPIC STRICTUROTOMY (ES) IN TREATING DEEP SMALL BOWEL STRICTURES. WE AIMED TO INVESTIGATE THE EFFICACY AND SAFETY OF BALLOON-ASSISTED ENTEROSCOPY-BASED ES (BAE- BASED ES) FOR DEEP SMALL BOWEL STRICTURES ASSOCIATED WITH CROHN¿S DISEASE (CD). METHODS: THIS MULTICENTRE RETROSPECTIVE COHORT STUDY INCLUDED CONSECUTIVE PATIENTS WITH CD-ASSOCIATED DEEP SMALL BOWEL STRICTURES TREATED WITH BAE-BASED ES BETWEEN 2017 AND 2023. THE OUTCOMES INCLUDED TECHNICAL SUCCESS, CLINICAL IMPROVEMENT, SURGERY-FREE RATE, REINTERVENTION-FREE RATE, AND ADVERSE EVENTS. RESULTS: TWENTY-EIGHT PATIENTS WITH CD UNDERWENT 58 BAE-BASED ES PROCEDURES FOR NON-PASSABLE DEEP SMALL BOWEL STRICTURES, WITH A MEDIAN FOLLOW-UP TIME OF 519.5 DAYS (INTERQUARTILE RANGE, 306¿728 DAYS). FIFTY-SIX (96.0%) PROCEDURES WERE TECHNICALLY SUCCESSFUL IN 26 (92.9%) PATIENTS. TWENTY PATIENTS (71.4%) SHOWED CLINICAL IMPROVEMENT AT WEEK 8. THE CUMULAT

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 18123261 ↗
• InjuryOct 23, 2023Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE TERRITORY MANAGER REPORTED ON BEHALF OF THE CUSTOMER THAT DURING A THERAPEUTIC, PERORAL ENDOSCOPIC MYOTOMY PROCEDURE, THE TIP OF THE SINGLE USE ELECTROSURGICAL KNIFE BROKE AND FELL INSIDE THE PATIENT BODY AND BROKEN TIP WAS RETRIEVED. THERE WAS NO MEDICAL INTERVENTION REQUIRED OTHER THAN THE RETRIEVAL OF THE FALLEN DEVICE. THE PROCEDURE WAS COMPLETED WITH A SIMILAR DEVICE WITH A DELAY OF AROUND 30 MINUTES. FURTHER FOLLOW-UP WITH THE CUSTOMER HAS BEEN CONDUCTED BUT ADDITIONAL INFORMATION IS UNAVAILABLE AT THE TIME OF THIS REPORT. NO PATIENT INJURY OR HARM REPORTED. THE DEVICE WAS INSPECTED PRIOR TO USE OF THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17986350 ↗
• 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 ↗
• InjurySep 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE DEVICE BREAKING OFF CAUSED A MINOR 15-MINUTE DELAY WHILE THE PATIENT WAS UNDER GENERAL ANESTHESIA WHICH HAD NO NEGATIVE IMPACT ON THE PATIENT. THE PROCEDURE WAS COMPLETED USING A SECOND SINGLE USE ELECTROSURGICAL KNIFE. THE PATIENT WAS DISCHARGED AS PLANNED WITH NO EXTENDED HOSPITAL STAY AS A RESULT OF THE DEVICE MALFUNCTION, AND WAS REPORTED TO BE IN GOOD HEALTH.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17821710 ↗

Other Olympus Medical Systems Corp. products

• EVIS EXERA lll COLONOVIDEOSCOPE16 models · 15,013 reports · 7 recalls
• EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE7 models · 13,448 reports · 7 recalls
• EVIS EXERA II ULTRASOUND GASTROVIDEOSCOPE9 models · 8,317 reports · 2 recalls
• EVIS EXERA III BRONCHOVIDEOSCOPE11 models · 6,060 reports · 16 recalls
• EVIS EXERA III XENON LIGHT SOURCE2 models · 6,694 reports
• EVIS EXERA III COLONOVIDEOSCOPE6 models · 6,117 reports · 5 recalls
• EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V2 models · 5,281 reports · 4 recalls
• HD CAMERA HEAD2 models · 5,217 reports