DISPOSABLE EMR KITRecalls & reported problems across all models

We found 6 models of DISPOSABLE EMR KIT by Olympus Medical Systems Corp. in the FDA's device registry (GUDID). Together they are named in 3 adverse event reports in the FDA's MAUDE database, received between Dec 13, 2022 and May 7, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (2 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

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

DISPOSABLE EMR KIT recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jul 27, 2023Open, Classified

   The Distal Attachment contain di-2-ethylhexyl phthalate (DEHP), which exceeds the permissible exposure level calculated according to ISO 10993-17: 2002

   Z-2522-2023 · Root cause: Nonconforming Material/Component · names 6 of these models · Recall details · FDA record ↗

Most reported DISPOSABLE EMR KIT problems

DISPOSABLE EMR KIT models

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

• DISPOSABLE EMR KIT K-001

  Gastroscope and accessories, flexible/rigid
  1 recall2 reports
• DISPOSABLE EMR KIT K-002

  Gastroscope and accessories, flexible/rigid
  1 recall1 report
• DISPOSABLE EMR KIT K-003

  Gastroscope and accessories, flexible/rigid
  1 recall0 reports
• DISPOSABLE EMR KIT K-004

  Gastroscope and accessories, flexible/rigid
  1 recall0 reports
• DISPOSABLE EMR KIT K-011

  Gastroscope and accessories, flexible/rigid
  1 recall0 reports
• DISPOSABLE EMR KIT K-012

  Gastroscope and accessories, flexible/rigid
  1 recall0 reports

Recent DISPOSABLE EMR KIT adverse event reports

The 3 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryMay 7, 2025Detachment of Device or Device Component; Material Split, Cut or Torn; Detachment of Device or Device Component; Material Split, Cut or Torn

  IT WAS REPORTED THAT DURING ENDOSCOPY, WHEN INSERTING THE MUCOSECTOMY KIT, THE CAP SPLIT IN TWO. THE DETACHED PART GOT STUCK IN THE ESOPHAGEAL MOUTH, AND THE PIECE WAS RECOVERED WITH DIFFICULTY USING RAT'S TOOTH FORCEPS. THE PROCEDURE WAS COMPLETED USING ANOTHER ENDOSCOPE WITHOUT REPORTS OF FURTHER PATIENT HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21980548 ↗
• MalfunctionFeb 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE CUSTOMER REPORTED TO OLYMPUS THAT DURING AN ESOPHAGEAL MUCOSECTOMY WITH THE OLYMPUS EMR KIT, THE RUBBER OF THE CAP RUPTURED AND THE CAP FELL INTO THE PATIENT¿S OROPHARYNX. THE CAP WAS RECOVERED FROM THE PATIENT OROPHARYNX WITH FORCEPS AND THE CASE WAS POSTPONED. THERE WAS NO PATIENT HARM DUE TO THE EVENT.

  Patient problems: Foreign Body In Patient

  MAUDE report 16301818 ↗
• InjuryDec 13, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED "POTENTIAL RISK DURING ENDOSCOPIC MANAGEMENT OF LARGE DUODENAL POLYPS." THIS MULTI-CENTER RETROSPECTIVE STUDY REVIEWS THE PATIENT CHARACTERISTICS, EMR TECHNIQUES, PROCEDURE OUTCOMES, ADVERSE EVENTS, AND RECURRENCE OF LARGE DUODENAL POLYPS IN 65 PATIENTS. . COMPLETE RESECTION OF THE VISIBLE MASS WAS ACHIEVED IN 96.9% OF CASES. THIS STUDY CONCLUDES THAT THE TALENTED ENDOSCOPISTS ARE CRITICALLY REQUIRED FOR ENDOSCOPIC MANAGEMENT OF LARGE DUODENAL POLYPS. WHILE MOST IMMEDIATE ADVERSE EVENTS CAN BE MANAGED ENDOSCOPICALLY, ALL PREVENTIVE MEASURES FOR DELAYED PERFORATION SHOULD BE APPLIED BEFORE COMPLETING EMR AS THESE USUALLY REQUIRE SURGICAL INTERVENTION. TYPE OF ADVERSE EVENTS/NUMBER OF PATIENTS. INTRAOPERATIVE BLEEDING - 12 PATIENTS. DELAYED PERFORATION - 2 PATIENTS. DELAYED BLEEDING - 7 PATIENTS. RECURRENCE - 11 PATIENTS. THIS LITERATURE ARTICLE REQUIRES 3 REPORTS. THE RELATED PATIENT IDENTIFIERS ARE AS FOLLOWS: (B)(6) : GIF-Q180. (B)(6) : TJF-160F. (B)(6) : K-001. THIS MEDWATCH REPORT IS FOR PATIENT IDENTIFIER (B)(6). THERE IS NO REPORT OF ANY OLYMPUS DEVICE MALFUNCTION IN ANY PROCEDURE DESCRIBED IN THIS STUDY.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Perforation

  MAUDE report 15973820 ↗

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