DISPOSABLE INJECTOR NM NM-200L-0423Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170381966), received between Feb 23, 2022 and Apr 13, 2022 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryApr 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "PROPENSITY SCORE MATCHING ANALYSIS TO EVALUATE EFFICACY OF POLYETHYLENE OXIDE ADHESIVE ON PREVENTING DELAYED BLEEDING AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION" BY YANG YU, ET AL.   REGARDLESS OF TECHNICAL ADVANCEMENTS, DELAYED BLEEDING IS STILL A COMMON ADVERSE EVENT AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD), OFTEN OCCURRING IN THE EARLY POSTOPERATIVE PHASE. THIS STUDY AIMED TO EVALUATE THE EFFICACY OF A NEWLY DESIGNED POLYETHYLENE OXIDE (PEO) ADHESIVE FOR PREVENTING DELAYED GASTRIC BLEEDING. PATIENTS WHO UNDERWENT GASTRIC ESD BETWEEN (B)(6) 2017 AND (B)(6) 2020 AT THREE (B)(6) INSTITUTIONS WERE RETROSPECTIVELY REVIEWED. PATIENTS RECEIVING PEO APPLICATION ON GASTRIC POST-ESD ULCERS WERE INCLUDED IN THE PEO GROUP, AND PATIENTS WITHOUT THIS PROCEDURE WERE INCLUDED IN THE CONTROL GROUP. TO MINIMIZE POTENTIAL BIAS, PROPENSITY SCORE MATCHING WAS PERFORMED, AND SEX, AGE, LESION SIZE, LESION MORPHOLOGY, ULCERATION, LOCALIZATION, PROCEDURE TIME, FREQUENCY OF MAJOR INTRAOPERATIVE BLEEDING, RESECTED SPECIMEN SIZE, LESION HISTOPATHOLOGY, SUBMUCOSAL INVASION AND THE TAKING OF ANTITHROMBOTIC DRUGS WERE INCLUDED AS MATCHING FAC

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Shock

  MAUDE report 14103872 ↗
• InjuryFeb 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE ARTICLE: "TRANSPARENT CAP-ASSISTED ENDOSCOPIC SCLEROTHERAPY IN ESOPHAGEAL VARICES: A RANDOMIZED-CONTROLLED TRIAL" BY LILI MAA, XIAOQUAN HUANGB, JINGJING LIAN, ET AL.THIS RANDOMIZED PROSPECTIVE, SINGLE-CENTER STUDY WAS AIMED TO DETERMINE THE FEASIBILITY, EFFICACY, AND COST OF PERFORMING ENDOSCOPIC INJECTION SCLEROSIS (EIS) WITH AND WITHOUT A TRANSPARENT CAP ATTACHED TO THE TIP OF THE GASTROSCOPE. A TOTAL OF 120 CONSECUTIVE PATIENTS WITH ESOPHAGEAL VARICES WITH OR WITHOUT GASTRIC VARICES WERE ENROLLED AND RANDOMIZED INTO TWO GROUPS, A CONTROL (N=61) AND A TRANSPARENT CAP-ASSISTED (N= 59) GROUP. THE PRIMARY AND SECONDARY OUTCOME MEASURES WERE TO DETERMINE WHETHER THE USE OF A TRANSPARENT CAP COULD REDUCE THE USE OF SALVAGE HEMOSTASIS METHODS WHILE INJECTION HEMORRHAGE COMPARING TO THE ENDOSCOPIC INJECTION WITHOUT A CAP AND TO IDENTIFY THE HEMORRHAGIC EVENTS THAT OCCURRED DURING INJECTION. MOREOVER, IT ALSO AIMED TO DETERMINE THE CONVENIENCE AND THE COST-EFFECTIVENESS OF USING TRANSPARENT CAP-ASSISTED ENDOSCOPY AND THE POSSIBILITY OF USING THIS TECHNIQUE IN CLINICAL PRACTICE. THE STUDY REPORTED A REDUCTION OF AVERAGE INJECTION SITES IN THE TRAN

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 13586796 ↗