DISPOSABLE ELECTROSURGICAL SNARERecalls & reported problems across all models
Olympus Medical Systems Corp. · 13 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 54
- Deaths reported
- 1
- Injuries reported
- 44
- Recalls
- 0
We found 13 models of DISPOSABLE ELECTROSURGICAL SNARE by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 54 adverse event reports in the FDA's MAUDE database, received between Oct 19, 2018 and Dec 2, 2025 — classified as 1 death, 44 injuries, 9 malfunctions.
The most frequently reported specific device problem is “Difficult to Remove” (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. 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
Reports received per month, all models
Most reported DISPOSABLE ELECTROSURGICAL SNARE problems
Device problems
- Adverse Event Without Identified Device or Use Problem36
- Difficult to Remove4
- Failure to Cut4
- Detachment of Device or Device Component2
- Break1
- Device Contamination with Chemical or Other Material1
- Difficult or Delayed Separation1
- Failure to Disconnect1
Patient problems
- Hemorrhage/Blood Loss/Bleeding22
- Perforation13
- No Clinical Signs, Symptoms or Conditions12
- Bowel Perforation5
- Abdominal Pain4
- Fever4
- Unspecified Gastrointestinal Problem3
- Bowel Burn2
DISPOSABLE ELECTROSURGICAL SNARE models
13 models, most reported first. Each model has its own page with its reports, recalls and device details.
- DISPOSABLE ELECTROSURGICAL SNARE SD-210U-15Electrosurgical, Cutting & Coagulation & Accessories9 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-210U-25Electrosurgical, Cutting & Coagulation & Accessories8 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-210U-10Electrosurgical, Cutting & Coagulation & Accessories6 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-240U-25SNARE, FLEXIBLE6 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-210U-10Electrosurgical, Cutting & Coagulation & Accessories6 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-230U-20SNARE, FLEXIBLE1 death5 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-210U-25Electrosurgical, Cutting & Coagulation & Accessories3 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-240U-25SNARE, FLEXIBLE3 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-210U-15Electrosurgical, Cutting & Coagulation & Accessories2 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-221U-25Gastroscope and accessories, flexible/rigid2 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-221L-25Gastroscope And Accessories, Flexible/Rigid2 reports
- DISPOSABLE ELECTROSURGICAL SNARE SD-240U-15SNARE, FLEXIBLE1 report
- DISPOSABLE ELECTROSURGICAL SNARE SD-221U-25Gastroscope And Accessories, Flexible/Rigid1 report
Recent DISPOSABLE ELECTROSURGICAL SNARE adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
MalfunctionDec 2, 2025Separation Failure; Separation Failure
IT WAS REPORTED THE ELECTROSURGICAL SNARE WAS NOT ABLE TO REMOVE THE POLYP DUE TO A WIRE FAILURE. THE ISSUE OCCURRED DURING A DIAGNOSTIC PROCEDURE (COLON SCREENING), WHICH WAS COMPLETED WITH A SIMILAR (NON-OLYMPUS) DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 23694343 ↗InjuryOct 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿SUCCESSFUL ENDOSCOPIC RESECTION BY USING GEL IMMERSION AND THE TECHNIQUE OF ENDOSCOPIC PAPILLECTOMY FOR A TUMOR ADJACENT TO THE PAPILLA OF VATER¿. LITERATURE SUMMARY. INTRODUCTION. SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS ARE RARE, AND THE ESTABLISHMENT OF OPTIMIZED STRATEGIES FOR THEIR TREATMENT IS AN AREA OF ACTIVE INVESTIGATION. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) FOR SUPERFICIAL NONAMPULLARY DUODENAL EPITHELIAL TUMORS POSES THE RISK OF MAJOR ADVERSE EVENTS (AES), INCLUDING A HIGH RATE OF BLEEDING, INTRAOPERATIVE PERFORATION, AND DELAYED PERFORATION. LESIONS LOCATED IN THE DUODENAL FLEXURE ARE ASSOCIATED WITH POOR ENDOSCOPE MANEUVERABILITY. MOREOVER, ENDOSCOPIC RESECTION IS PARTICULARLY CHALLENGING FOR LESIONS ON THE DESCENDING DUODENUM¿S MEDIAL WALL, ESPECIALLY THOSE ADJACENT TO THE PAPILLA OF VATER (POV). IF ENDOSCOPIC RESECTION IS NOT POSSIBLE, A PANCREATICODUODENECTOMY, WHICH IS A HIGHLY INVASIVE SURGERY, CAN BE PERFORMED. GEL IMMERSION ENDOSCOPY IS USED TO CONTROL GASTROINTESTINAL BLEEDING BY FLUSHING OUT BLOOD AND CLOTS TO SECURE A GOOD VISUAL FIELD. SINCE THERE IS NO CARBON DIOXIDE (CO2) INSUFFLATION DURING D
Patient problems: Perforation
MAUDE report 23302590 ↗MalfunctionMay 7, 2025Difficult or Delayed Separation; Difficult or Delayed Separation
IT WAS REPORTED THE SUBJECT DEVICE SNARE WAS NOT COMPLETELY OPENED DURING SNARE CAUTERIZATION. THE SNARE TIP WAS REPORTED AS SLIGHTLY SLANTED AND DID NOT WORK AS INTENDED. THIS ISSUE OCCURRED DURING A THERAPEUTIC ENDOSCOPIC MUCOSAL RESECTION PROCEDURE. THE PROCEDURE WAS COMPLETED WITH A BACK UP DEVICE. THERE WERE NO REPORTS OF PATIENT HARM.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21979720 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "VALIDATION OF A NOVEL BCM MODEL FOR RECURRENCE RISK PREDICTION AFTER MUCOSECTOMY OF COLORECTAL LATERAL SPREADING TUMORS IN A EUROPEAN COHORT". LITERATURE SUMMARY BACKGROUND AND AIM: PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION (PEMR) IS THE BEST APPROACH TO RESECT LARGE LATERAL SPREADING TUMORS (LST, > 20 MM WIDTH). HOWEVER, IT IS ASSOCIATED WITH EARLY RECURRENCE (ER) AND LATE RECURRENCE (LR). THIS STUDY AIMS TO ASSESS THE RISK FACTORS ASSOCIATED WITH ER AND LR AND TO VALIDATE DIFFERENT PREDICTIVE SCORES (SMSA, SERT, AND BCM) IN IDENTIFYING THE RISK OF ER AND LR AFTER LST RESECTED BY PEMR IN A EUROPEAN COHORT. METHODS: RETROSPECTIVE OBSERVATIONAL COHORT STUDY, BASED ON A PROSPECTIVELY COLLECTED DATABASE, OF LARGE LST SUBMITTED TO PEMR. RESULTS: A TOTAL OF 108 PATIENTS WERE INCLUDED IN THE STUDY AND THE INCIDENCE RATES OF ER AND LR WERE 22 % AND 8%, RESPECTIVELY. THE LESION¿S SIZE, SERT, AND BCM SCORES WERE INDEPENDENT PREDICTOR FACTORS OF ER (P-VALUE <0.05), WHILE THE LESION¿S SITE AND BCM SCORE WERE INDEPENDENT PREDICTOR FACTORS OF LR (P-VALUE < 0.05). FOR THE PREDICTION OF ER, THE SERT SCORE (CUT-OFF > 1) PRESENTED THE HIGHEST AUROC (0.
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Gastrointestinal Problem
MAUDE report 20268014 ↗InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "VALIDATION OF A NOVEL BCM MODEL FOR RECURRENCE RISK PREDICTION AFTER MUCOSECTOMY OF COLORECTAL LATERAL SPREADING TUMORS IN A EUROPEAN COHORT". LITERATURE SUMMARY: BACKGROUND AND AIM: PIECEMEAL ENDOSCOPIC MUCOSAL RESECTION (PEMR) IS THE BEST APPROACH TO RESECT LARGE LATERAL SPREADING TUMORS (LST, > 20 MM WIDTH). HOWEVER, IT IS ASSOCIATED WITH EARLY RECURRENCE (ER) AND LATE RECURRENCE (LR). THIS STUDY AIMS TO ASSESS THE RISK FACTORS ASSOCIATED WITH ER AND LR AND TO VALIDATE DIFFERENT PREDICTIVE SCORES (SMSA, SERT, AND BCM) IN IDENTIFYING THE RISK OF ER AND LR AFTER LST RESECTED BY PEMR IN A EUROPEAN COHORT. METHODS: RETROSPECTIVE OBSERVATIONAL COHORT STUDY, BASED ON A PROSPECTIVELY COLLECTED DATABASE, OF LARGE LST SUBMITTED TO PEMR. RESULTS: A TOTAL OF 108 PATIENTS WERE INCLUDED IN THE STUDY AND THE INCIDENCE RATES OF ER AND LR WERE 22 % AND 8%, RESPECTIVELY. THE LESION¿S SIZE, SERT, AND BCM SCORES WERE INDEPENDENT PREDICTOR FACTORS OF ER (P-VALUE <0.05), WHILE THE LESION¿S SITE AND BCM SCORE WERE INDEPENDENT PREDICTOR FACTORS OF LR (P-VALUE < 0.05). FOR THE PREDICTION OF ER, THE SERT SCORE (CUT-OFF > 1) PRESENTED THE HIGHEST AUROC (0
Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation; Unspecified Gastrointestinal Problem
MAUDE report 20267993 ↗InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT IN A CLINICAL STUDY PATIENT, COLONOSCOPY WAS PERFORMED AT AN OUTPATIENT CLINIC, AND POLYPS WERE REMOVED FROM 20 LESIONS FROM THE CECUM TO THE RECTUM. ONE LESION IN THE ASCENDING COLON AND ONE LESION IN THE TRANSVERSE COLON WERE DEEMED ELIGIBLE FOR THIS STUDY, AND THE PATIENT WAS ENROLLED IN THE STUDY AND UNDERWENT PROTOCOL TREATMENT. THERE WERE NO ADVERSE EVENTS DURING SURGERY, AND THE PATIENT WAS DISCHARGED THE SAME DAY. LATER, ON THE NIGHT AFTER THE SURGICAL PROCEDURE, THE PATIENT VISITED THE EMERGENCY ROOM COMPLAINING OF ABDOMINAL PAIN. AFTER DETAILED EXAMINATION, THE PATIENT WAS DIAGNOSED WITH DELAYED PERFORATION AFTER POLYPECTOMY. EMERGENCY SURGERY WAS PERFORMED ON THE SAME DAY, AND A PERFORATION WAS FOUND IN THE CECUM CONTRALATERAL TO THE ILEOCECAL REGION, AND A PARTIAL APPENDECTOMY AND LAVAGE DRAINAGE WERE PERFORMED. THE SITE OF THE PERFORATION WAS THE SITE WHERE APPENDICEAL ADENOMA HAD BEEN REMOVED WITH HOT SNARE POLYPECTOMY AND TREATED ACCORDING TO THE PROTOCOL, AND IT HAS BEEN DETERMINED THAT THERE IS NO PROBLEM WITH CONTINUING THE CLINICAL STUDY. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. NO REPORTS OF FURTHER PATIENT HARM/INJURY.
Patient problems: Abdominal Pain; Bowel Perforation
MAUDE report 20242169 ↗InjurySep 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) REVIEWED A LITERATURE TITLED "COLORECTAL POST-POLYPECTOMY BLEEDING IN OUTPATIENT VERSUS INPATIENT TREATMENT: PROPENSITY SCORE MATCHING ANALYSIS". LITERATURE SUMMARY OBJECTIVES: DELAYED BLEEDING IS THE MOST FREQUENT ADVERSE EVENT ASSOCIATED WITH ENDOSCOPIC MUCOSAL RESECTION (EMR) AND HOT SNARE POLYPECTOMY (HSP) OF COLORECTAL POLYPS. HOWEVER, WHETHER THE INCIDENCE OF DELAYED BLEEDING DIFFERS BETWEEN OUTPATIENT AND INPATIENT TREATMENT IS UNKNOWN. THEREFORE, IN THIS STUDY, WE AIMED TO EVALUATE DELAYED BLEEDING RATES BETWEEN OUTPATIENT AND INPATIENT ENDOSCOPIC TREATMENTS AND CLARIFY THE SAFETY OF OUTPATIENT TREATMENT. METHODS: WE ENROLLED 469 PATIENTS (1077 POLYPS) AND 420 PATIENTS (1080 POLYPS) IN THE OUTPATIENT AND INPATIENT GROUPS, RESPECTIVELY, WHO UNDERWENT EMR OR HSP FOR COLORECTAL POLYPS AT OUR INSTITUTION BETWEEN (B)(6) 2023. USING PROPENSITY SCORE MATCHING, WE EVALUATED THE DELAYED BLEEDING RATES BETWEEN THE TWO GROUPS. DELAYED BLEEDING WAS DEFINED AS A HEMORRHAGE REQUIRING ENDOSCOPIC HEMOSTASIS OCCURRING WITHIN 14 DAYS OF THE PROCEDURE. RESULTS: PROPENSITY SCORE MATCHING CREATED 376 (954 POLYPS) MATCHED PATIENT PAIRS. THE MEDIAN MAXIMUM DIA
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 20145753 ↗InjuryJul 23, 2024Detachment of Device or Device Component; Detachment of Device or Device Component
INFORMATION INADVERTENTLY LEFT OUT: IT WAS REPORTED THAT THE NOOSE DID NOT REMAIN IN THE PATIENT. ADDITIONAL INFORMATION RECEIVED: IT WAS REPORTED THAT THE GUIDEWIRE DETACHED INSIDE THE DUODENOSCOPE AND WAS FOUND TO BE OFF WHEN IT WAS PULLED OUT. ADDITIONALLY, THE FOREIGN OBJECT WAS A HYDRA JAGWIRE GUIDEWIRE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19808770 ↗InjuryJul 23, 2024Break; Break
INFORMATION INADVERTENTLY LEFT OUT: IT WAS REPORTED THAT THE NOOSE DID NOT REMAIN IN THE PATIENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19808539 ↗InjuryJun 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "VWS02-3 TREATMENT OUTCOMES OF ENDOSCOPIC PAPILLECTOMY FOR DUODENAL PAPILLA CANCER". LITERATURE SUMMARY [BACKGROUND] THERE IS NO CONSENSUS ON THE INDICATIONS FOR ENDOSCOPIC PAPILLECTOMY (EP) FOR DUODENAL PAPILLA CANCER. [OBJECTIVE] TO INVESTIGATE THE SAFETY AND PROGNOSIS OF EP FOR DUODENAL PAPILLA CANCER. [METHOD] AMONG 77 CASES OF PAPILLA TUMORS WHO UNDERWENT EP BETWEEN MAY 2002 AND OCTOBER 2023, 33 CASES (4 TIS, 25 T1A (M), 2 T1A (OD), AND 2 T1B (DU)) WITH A FINAL PATHOLOGICAL DIAGNOSIS OF ADENOCARCINOMA WERE INCLUDED. WE COMPARED THE EN BLOC RESECTION RATE, PATHOLOGICAL COMPLETE RESECTION RATE, ADVERSE EVENTS, RECURRENCE RATE, AND RECURRENCE PATTERN WITH 44 ADENOMA CASES FROM THE SAME PERIOD AS CONTROLS. [RESULTS] THE EN BLOC RESECTION RATE AND PATHOLOGICAL COMPLETE RESECTION RATE WERE 94% (31/33) AND 42% (14/33) FOR ADENOCARCINOMA AND 89% (39/44) AND 52% (23/44) FOR ADENOMA (P=0.69, 0.49, RESPECTIVELY). EARLY ADVERSE EVENTS WERE OBSERVED IN 30% (10/33) OF ADENOCARCINOMA PATIENTS (7 CASES OF BLEEDING, 4 CASES OF PANCREATITIS, 4 CASES OF PERFORATION, 1 CASE OF CHOLANGITIS) AND 36% (16/44) OF ADENOMA PATIENTS (10 CASES OF BLEEDING,
Patient problems: Cholangitis; Hemorrhage/Blood Loss/Bleeding; Pancreatitis; Perforation; Stenosis; Unspecified Hepatic or Biliary Problem
MAUDE report 19619967 ↗InjuryJun 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT DURING A MIDDLE OF A THERAPEUTIC GASTROINTESTINAL ENDOSCOPIC MUCOSAL RESECTION (EMR) AND REMOVING THE POLYP (IN A MALE, JAPANESE PATIENT) A BURN WAS REPORTED WHICH WAS LARGER THAN USUAL. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE. THE PATIENT EXPERIENCED ABDOMINAL PAIN AND FEVER AFTER RETURNING HOME. UPON EXAMINATION, THE TISSUE WAS CAUTERIZED OVER A LARGER AREA THAN THE DOCTOR EXPECTED. THE BURN HAD SPREAD TO THE TISSUE. SO, THE PATIENT WAS TRANSFERRED TO ANOTHER HOSPITAL AND REMAINED HOSPITALIZED. THE EXAMINATION REVEALED NO PERFORATION. THE BURN DID NOT EXTEND TO THE MUSCLE LAYER BUT FIVE CLIPS WERE USED TO STOP THE BLEEDING. FOLLOW UP INFORMATION REVEALED THAT THE PATIENT HAD A SECOND-DEGREE BURN AND ANTIBIOTICS WERE ADMINISTERED. A BLOOD TEST WAS PERFORMED AS A FOLLOW UP EXAMINATION AND INFLAMMATORY REACTION WAS NOTED.
Patient problems: Abdominal Pain; Bowel Burn; Fever; Hemorrhage/Blood Loss/Bleeding; Inflammation
MAUDE report 19515549 ↗InjuryApr 22, 2024Failure to Disconnect; Failure to Disconnect
IT WAS REPORTED THAT THE SNARE WAS STUCK AND TWISTED ON A POLYP, WHILE USING THE ENDOTHERAPY. THERE WAS NO PATIENT HARM ASSOCIATED WITH THE EVENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19155944 ↗DeathApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED BY THE AUTHOR THAT AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.
Patient problems: Insufficient Information
MAUDE report 19053615 ↗InjuryMar 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE ADVERSE EVENTS DESCRIBED IN THE ARTICLE. ALSO, IT WAS CONFIRMED THAT THERE WAS NO MALFUNCTION OF AN OLYMPUS DEVICE.
Patient problems: Perforation
MAUDE report 18986045 ↗InjuryMar 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
OLYMPUS CORPORATION RECEIVED A LITERATURE TITLED "UNDERWATER VERSUS CONVENTIONAL EMR FOR NONPEDUNCULATED COLORECTAL LESIONS: A RANDOMIZED CLINICAL TRIAL". BACKGROUND AND AIMS: CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (CEMR) IS THE STANDARD MODALITY FOR REMOVING NONPEDUNCULATED COLORECTAL LESIONS. UNDERWATER ENDOSCOPIC MUCOSAL RESECTION (UEMR) HAS EMERGED AS AN ALTERNATIVE METHOD. THERE ARE FEW COMPARATIVE STUDIES BETWEEN THESE TECHNIQUES, ESPECIALLY EVALUATING RECURRENCE. THEREFORE, THE PURPOSE OF THIS TRIAL WAS TO COMPARE CEMR AND UEMR FOR THE RESECTION OF COLORECTAL LESIONS WITH RESPECT TO EFFICACY, SAFETY, AND RECURRENCE RATE. METHODS: THIS WAS A RANDOMIZED CONTROLLED TRIAL OF UEMR VERSUS CEMR FOR NAÏVE AND NONPEDUNCULATED LESIONS MEASURING BETWEEN 10 AND 40 MM. THE PRIMARY OUTCOME WAS ADENOMA RECURRENCE AT 6 MONTHS AFTER THE RESECTION. SECONDARY OUTCOMES WERE RATES OF TECHNICAL SUCCESS, EN BLOC RESECTION, AND ADVERSE EVENTS. BLOCK RANDOMIZATION WAS USED TO ASSIGN PATIENTS. TATTOOING WAS PERFORMED TO FACILITATE LOCALIZATION OF THE SCARS AND EVENTUAL RECURRENCES. ENDOSCOPIC FOLLOW-UP WAS SCHEDULED AT 6 MONTHS AFTER THE PROCEDURE. THE SITES OF RESECTIONS WERE EXAMINED WITH WHITE-
Patient problems: Hemorrhage/Blood Loss/Bleeding
MAUDE report 18833744 ↗
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
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page