DISTAL HOOD DISTAL HOOD 12602 MAJ-1990Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 04953170314407), received between Jan 10, 2023 and Nov 25, 2024 — classified as 2 injuries.

The most frequently reported specific device problem is “Component Missing” (1 report).

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.

• InjuryNov 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  OLYMPUS REVIEWED THE FOLLOWING LITERATURE TITLED ¿LOW-POWER PURE-CUT HOT SNARE POLYPECTOMY FOR COLORECTAL POLYPS 10-14 MM IN SIZE: A MULTICENTER RETROSPECTIVE STUDY¿. BACKGROUND AND AIM: HOT SNARE EXCISION USING ELECTROCAUTERY IS WIDELY USED FOR LARGE COLORECTAL POLYPS (>10 MM); HOWEVER, ADVERSE EVENTS OCCUR DUE TO DEEP THERMAL INJURY. COLORECTAL POLYPS MEASURING 10¿14 MM RARELY INCLUDE INVASIVE CANCER. THEREFORE, LESS INVASIVE THERAPEUTIC OPTIONS FOR THIS SIZE CATEGORY ARE DEMANDING. WE HAVE DEVELOPED HOT SNARE POLYPECTOMY WITH LOW-POWER PURE-CUT CURRENT (LPPC HSP), WHICH IS EXPECTED TO CONTRIBUTE TO LESS DEEP THERMAL DAMAGE AND LOWER RISK OF ADVERSE EVENTS. THIS STUDY AIMED TO EVALUATE THE EFFICACY AND SAFETY OF LPPC HSP FOR 10¿14 MM COLORECTAL POLYPS, COMPARED WITH CONVENTIONAL ENDOSCOPIC MUCOSAL RESECTION (EMR). METHODS: IN THIS MULTICENTER, RETROSPECTIVE, OBSERVATIONAL STUDY, CLINICAL OUTCOMES OF EMR AND LPPC HSP FOR 10¿14 MM NONPEDUNCULATED COLORECTAL POLYPS BETWEEN (B)(6) 2021 AND (B)(6) 2022 WERE COMPARED USING PROPENSITY SCORE MATCHING. RESULTS: WE IDENTIFIED (B)(4). AFTER PROPENSITY SCORE MATCHING, THE BASELINE CHARACTERISTICS BETWEEN THE GROUPS WERE COMPARABLE, WITH (B)(

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20775853 ↗
• InjuryJan 10, 2023Component Missing; Component Missing

  AN OLYMPUS REPRESENTATIVE REPORTED TO OLYMPUS ON BEHALF OF THE CUSTOMER THAT AFTER AN ENDOSCOPIC EXAMINATION AND INSPECTION IS OVER, THIS DISTAL HOOD WAS MISSING. THE ENDOSCOPE WAS INSERTED AGAIN TO THE DESCENDING LEG OF THE DUODENUM, BUT THE HOOD COULD NOT BE FOUND. THE PATIENT REFUSED ADDITIONAL PROCEDURE AND WAS DISCHARGED HOME. A FOLLOW-UP WAS APPROVED. THERE WERE NO REPORTS OF PATIENT OR USER HARM ASSOCIATED WITH THIS EVENT. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE DISTAL HOOD USED IN THE PROCEDURE. CASE WITH PATIENT IDENTIFIER (B)(6) REPORTS THE EVIS LUCERA GASTROINTESTINAL VIDEOSCOPE USED IN THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16134175 ↗