Olmypus WA63728ARecalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04042761031059), received between Mar 14, 2022 and Mar 14, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K912362, K923982); they may or may not involve this specific model.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryMar 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT IS REPORTED IN THE LITERATURE TITLED ¿ENDOSCOPIC HAND SUTURING FOR MUCOSAL DEFECT CLOSURE AFTER GASTRIC ENDOSCOPIC SUBMUCOSAL DISSECTION MAY REDUCE THE RISK OF POSTOPERATIVE BLEEDING IN PATIENTS RECEIVING ANTITHROMBOTIC THERAPY¿, PATIENTS EXPERIENCED ADVERSE EVENTS DURING OR AFTER PROCEDURES USING OLYMPUS DEVICES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE KD-650L USED IN THE ESD PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE FD-411QR USED IN THE ESD PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6)WILL REPORT THE FG-21L-1 USED IN THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE HX-610-090S USED DURING THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE GIF-2TQ260M USED DURING THE EHS PROCEDURES. CASE WITH PATIENT IDENTIFIER (B)(6) WILL REPORT THE THROUGH THE SCOPE NEEDLE HOLDER USED DURING THE EHS PROCEDURES. STUDY AIM: ENDOSCOPIC HAND SUTURING (EHS) IS EXPECTED TO DECREASE THE RISK OF POST-ENDOSCOPIC SUBMUCOSAL DISSECTION (ESD) BLEEDING BY CLOSING MUCOSAL DEFECTS. THE STUDY INVESTIGATED THE EFFICACY OF EHS AFTER GASTRIC ESD IN PATIENTS WITH ANTITHROMBOTIC AGENTS. STUDY METHOD: PROSPECTIVE SINGLE-ARM TRIAL, PATI

  Patient problems: Chest Pain; Myocardial Infarction

  MAUDE report 13763316 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K912362, K923982. One submission often covers many models, so check the product and lot details in each record.

• Z-1163-2010 · Feb 8, 2010 · Terminated
  Olympus Trocar Spikes, Model numbers: A5821, A5948, A5949, WA58341L, and WA58343L Used in conjunction with a compatible trocar tube, trocar tubes are used for intraperitoneal acce