Single Use Electrosurgical Hemostatic Forceps FD-412LRRecalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04953170359804), received between May 11, 2018 and May 15, 2024 — classified as 15 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Failure to Deliver Energy” (3 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjuryMay 15, 2024Failure to Deliver Energy; Failure to Deliver Energy

  IT WAS REPORTED, THE SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS HAD NO ENERGY OUTPUT DURING A GASTROSCOPY BEING DONE FOR AN UPPER GASTROINTESTINAL (GI) BLEED. THE PATIENT HAD A SEVERE BLEED IN THE UPPER GI TRACT, AND THE FAILED DEVICE CAUSED A DELAY IN TREATMENT. THE PROCEDURE WAS PROLONGED FOR AN UNKNOWN DURATION WHILE THE PATIENT WAS UNDER ANESTHESIA USING PROPOFOL. THE ERBY ELECTROSURGICAL UNIT WAS TURNED OFF AND ON, BUT IT DID NOT CHANGE ANYTHING. A SECOND SET OF COAGRASPERS WAS USED AND WAS SUCCESSFUL. THE PROCEDURE WAS COMPLETED WITHOUT FURTHER INCIDENT.

  Patient problems: Gastrointestinal Hemorrhage

  MAUDE report 19322285 ↗
• InjuryApr 12, 2024Energy Output Problem; Energy Output Problem

  IT WAS REPORTED THAT DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURE, THE SINGLE USE ELECTROSURGICAL HEMOSTATIC FORCEPS COULD NOT BE ENERGIZED, AND BLEEDING COULD NOT BE STOPPED AND CAUTERIZATION COULD NOT BE ACHIEVED, EVEN AFTER THE DEVICE OUTPUT WAS INCREASED THEREFORE, A HEMOSTATIC CLIP (UNDER ENDOSCOPIC GUIDANCE) WAS USED TO STOP THE BLEEDING, AND PROCEDURE WAS COMPLETED. THERE WAS NO HEALTH DAMAGE TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19097286 ↗
• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE AUTHOR CONFIRMED THAT AN OLYMPUS DEVICE DID NOT CAUSE OR CONTRIBUTE TO ANY PATIENT ADVERSE EVENTS DESCRIBED IN THE LITERATURE

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 17899754 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA." BACKGROUND AND AIMS: ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WITH

  Patient problems: Bacterial Infection

  MAUDE report 16328551 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA.". BACKGROUND AND AIMS ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WITH

  Patient problems: Fever; Perforation

  MAUDE report 16326725 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA.". BACKGROUND AND AIMS. ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS: IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WIT

  Patient problems: Bacterial Infection

  MAUDE report 16326649 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA." BACKGROUND AND AIMS ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WITH PE

  Patient problems: Bacterial Infection

  MAUDE report 16326546 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA." BACKGROUND AND AIMS ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N¿=¿40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N¿=¿63) (ALL P¿>¿0.05). THE T, WBC, AND CRP LEVELS (ALL P¿<¿0.05) IN THE PATIENTS

  Patient problems: Bacterial Infection; Perforation

  MAUDE report 16325911 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA.". BACKGROUND AND AIMS ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WITH

  Patient problems: Bacterial Infection; Fever; Perforation

  MAUDE report 16325854 ↗
• InjuryFeb 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "PROPHYLACTIC ANTIBIOTICS MAY BE UNNECESSARY IN GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION DUE TO THE LOW INCIDENCE OF BACTEREMIA.". BACKGROUND AND AIMS ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) WAS DEVELOPED AS A FEASIBLE AND RELIABLE TREATMENT FOR GASTROINTESTINAL MUCOSAL OR SUBMUCOSAL LESIONS. BACTEREMIA MAY OCCUR AFTER ESD. CURRENTLY, THE USE OF PROPHYLACTIC ANTIBIOTICS AFTER GASTRIC ESD IS CONTROVERSIAL. THIS STUDY WAS DESIGNED TO EXPLORE THE VALUE OF PROPHYLACTIC ANTIBIOTICS IN THE TREATMENT OF GASTRIC MUCOSAL AND SUBMUCOSAL LESIONS AFTER ESD. METHODS IN THIS PROSPECTIVE STUDY, IN TOTAL, 103 PATIENTS WHO UNDERWENT GASTRIC ESD WERE INCLUDED, AND THE FREQUENCY OF BACTEREMIA AND CHANGES IN INFLAMMATION-RELATED INDICATORS BEFORE AND AFTER THE PROCEDURE WERE INVESTIGATED. THE PATIENTS DID NOT RECEIVE PROPHYLACTIC ANTIBIOTICS. RESULTS: THE BODY TEMPERATURE (T), WHITE BLOOD CELL COUNT (WBC), AND PROCALCITONIN (PCT) AND C-REACTIVE PROTEIN (CRP) LEVELS DID NOT SIGNIFICANTLY DIFFER BETWEEN THE PERFORATION GROUP (N=40) AND NONPERFORATION GROUP BEFORE GASTRIC ESD (N=63) (ALL P>0.05). THE T, WBC, AND CRP LEVELS (ALL P<0.05) IN THE PATIENTS WITH

  Patient problems: Bacterial Infection; Perforation

  MAUDE report 16325735 ↗
• InjuryDec 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿CARBAZOCHROME SODIUM SULFONATE IS NOT EFFECTIVE FOR PREVENTION OF POST GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION BLEEDING: A RETROSPECTIVE STUDY,¿ PATIENTS EXPERIENCED ADVERSE EVENTS POST-PROCEDURE(S). BACKGROUND: CARBAZOCHROME SODIUM SULFONATE (CSS) IS CONVENTIONALLY ADMINISTERED TO PREVENT POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BLEEDING IN MANY INSTITUTIONS, BUT RESEARCH ON ITS PREVENTIVE EFFICACY IS LACKING. THEREFORE, WE INVESTIGATED THE RISK OF POST-ESD BLEEDING AND THE PREVENTIVE EFFICACY OF CSS ADMINISTRATION. METHODS: WE RETROSPECTIVELY REVIEWED 304 LESIONS IN 259 PATIENTS WITH GASTRIC NEOPLASMS WHO UNDERWENT ESD AT ASAHIKAWA MEDICAL UNIVERSITY HOSPITAL FROM 2014 TO 2021. IN THE CSS GROUP, CSS 100 MG/DAY WAS INTRAVENOUSLY INFUSED WITH MAINTENANCE FLUID REPLACEMENT ON POSTOPERATIVE DAYS 0¿2. THE RISK FACTORS OF POST-ESD BLEEDING, INCLUDING CSS ADMINISTRATION, WERE INVESTIGATED. RESULTS: THE OVERALL RATE OF POST-ESD BLEEDING WAS 4.6% (14/304). THE UNIVARIATE ANALYSIS SHOWED THAT ATRIAL FIBRILLATION (AF), WARFARIN INTAKE, HEPARIN REPLACEMENT, AND TUMOR LOCATION IN THE LOWER THIRD WERE SIGNIFICANT RISK FACTORS FOR INCREASING THE LIKE

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 16014011 ↗
• InjuryJan 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SUBJECT DEVICE WAS USED DURING PROBABLY AN ENDOSCOPIC SUBMUCOSAL DISSECTION. WHEN THE SUBJECT DEVICE WAS APPLIED TO THE GREATER CURVATURE OF THE GASTRIC CORPUS WITH ACTIVATION IN SOFT COAGULATION MODE, PERFORATION OCCURRED. THE SURGICAL OPERATION WAS PERFORMED TO CLOSE THE PERFORATION. PATIENT HAD GOOD PROGNOSIS AND NO OTHER TREATMENT WAS NECESSARY. IT WAS ADDITIONALLY REPORTED THAT THE USER DIDN'T PRESS THE SUBJECT DEVICE HARD, BUT THE ENERGIZING TIME MIGHT HAVE BEEN A LITTLE LONGER.

  Patient problems: Perforation

  MAUDE report 11152538 ↗
• InjuryJul 13, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON JUN 15, 2020, OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED LITERATURE TITLED "A CASE OF GASTRIC PSEUDOANEURYSM FOLLOWING ENDOSCOPIC SUBMUCOSAL DISSECTION OF EARLY GASTRIC CANCER". IN THE LITERATURE, IT WAS REPORTED THAT BLEEDING AND PSEUDOANEURYSM WERE OBSERVED IN A PATIENT WITH THE ENDOSCOPIC SUBMUCOSAL DISSECTION. DURING ESD, NO MUSCULAR LAYER OF DAMAGES OR PERFORATIONS WERE EVIDENT, AND THERE WAS NO BLEEDING THAT WAS DIFFICULT TO STOP. THE ESD PROCEDURE WAS PERFORMED USING THE ELECTROSURGICAL KNIFE (DUALKNIFE, IT-KNIFE). IN THE CASE OF BLEEDING, HEMOSTASIS WAS PERFORMED USING HIGH-FREQUENCY HEMOSTATIC FORCEPS (COAGRASPER G) AND ARGON PLASMA COAGULATION (APC). THE MODEL NUMBER WAS NOT IDENTIFIED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE OLYMPUS PRODUCT AND THE OBSERVED ADVERSE EVENTS COULD NOT BE DETERMINED. HOWEVER, IN THE LITERATURE, IT WAS REPORTED THAT HIGH-FREQUENCY COAGULATION AT THE TIME OF HEMOSTASIS DURING OR AFTER ESD WAS CONSIDERED TO HAVE THE FOLLOWING INFLUENCE. A PENETRATING VESSEL FROM THE LEFT GASTRIC ARTERY IN THE MUSCULAR LAYER AT THE MUCOSAL DEFECT MAY HAVE COLLAPSED, RESULTING IN THE FORMATION OF THE PSEUDOANEURYSM, WHICH RUPTU

  Patient problems: Blood Loss

  MAUDE report 10263897 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "EFFICACY OF VONOPRAZAN FOR THE PREVENTION OF BLEEDING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION WITH CONTINUOUS USE OF ANTIPLATELET AGENTS". THE LITERATURE REPORTED THE RESULT OF 49 CASES OF THE GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURES USING AN OLYMPUS MODEL AN INSULATED TIPPED (IT) KNIFE (KD-611L) AND A COAGRASPER (FD-412LR) BETWEEN DECEMBER 2015 AND JUNE 2018. IN THE SUBJECT PROCEDURES, 1 CASE OF POST ESD BLEEDING AND 1 CASE OF INTRAOPERATIVE PERFORATION REPORTEDLY OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENT COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF THE ACCIDENTAL SYMPTOMS KNOWN AND THE NUMBER OF OLYMPUS DEVICES USED FOR THE PROCEDURE, OMSC IS SUBMITTING 4 MEDICAL DEVICE REPORTS. THIS IS THE 2ND OF 4 REPORTS.

  Patient problems: Injury

  MAUDE report 10065490 ↗
• InjuryMay 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS MEDICAL SYSTEMS CORP. (OMSC) RECEIVED A LITERATURE TITLE "EFFICACY OF VONOPRAZAN FOR THE PREVENTION OF BLEEDING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION WITH CONTINUOUS USE OF ANTIPLATELET AGENTS". THE LITERATURE REPORTED THE RESULT OF 49 CASES OF THE GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) PROCEDURES USING AN OLYMPUS MODEL AN INSULATED TIPPED (IT) KNIFE (KD-611L) AND A COAGRASPER (FD-412LR) BETWEEN DECEMBER 2015 AND JUNE 2018. IN THE SUBJECT PROCEDURES, 1 CASE OF POST ESD BLEEDING AND 1 CASE OF INTRAOPERATIVE PERFORATION REPORTEDLY OCCURRED. BASED ON THE AVAILABLE INFORMATION, A DIRECT RELATIONSHIP BETWEEN THE SUBJECT DEVICES AND THE OBSERVED REPORTED ADVERSE EVENT COULD NOT BE DETERMINED. ACCORDING TO THE NUMBER OF THE ACCIDENTAL SYMPTOMS KNOWN AND THE NUMBER OF OLYMPUS DEVICES USED FOR THE PROCEDURE, OMSC IS SUBMITTING 4 MEDICAL DEVICE REPORTS. THIS IS THE 4TH OF 4 REPORTS.

  Patient problems: Injury

  MAUDE report 10065483 ↗
• MalfunctionJun 14, 2018Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION, THE SUBJECT DEVICE WAS USED. DURING THE PROCEDURE, THE DOCTOR USED THE SUBJECT DEVICE FOR HEMOSTASIS, BUT THE SUBJECT DEVICE DID NOT ACTIVATE OUTPUT. THE INTENDED PROCEDURE WAS COMPLETED WITH ANOTHER DEVICE. THERE WAS NO PATIENT INJURY REPORTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7600282 ↗
• MalfunctionMay 11, 2018Failure to Deliver Energy; Failure to Deliver Energy

  DURING AN ENDOSCOPIC SUBMUCOSAL DISSECTION OF THE STOMACH, FD-410LR AND THE SUBJECT DEVICE(FD-412LR) WERE USED. IN THE PROCEDURE, FD-410LR COULD NOT BE ACTIVATED ONLY THE SOFT COAGULATION MODE. THE USER EXCHANGED IT WITH THE SECOND DEVICE(FD-412LR). IT COULD NOT BE ACTIVATED. THE INTENDED PROCEDURE WAS COMPLETED. THERE WAS NO PATIENT INJURY REPORTED. NO FURTHER INFORMATION WAS PROVIDED. THIS IS THE REPORT REGARDING FAILURE OF ACTIVATION FOR THE SECOND DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7505711 ↗