DISPOSABLE EMR KIT K-001Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170048562), received between Dec 13, 2022 and Feb 4, 2023 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (1 report).

1 FDA recall record name this device's 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, 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.

Recalls naming this device

1. Jul 27, 2023Class IIOpen, 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 · Recall details · FDA record ↗

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.

• 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 ↗