E-LINE 86553441Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207028087), received between Apr 20, 2017 and Apr 20, 2017 — classified as 1 malfunction.

The most frequently reported specific device problem is “Material Fragmentation” (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 16, 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.

• MalfunctionApr 20, 2017Material Fragmentation; Material Fragmentation

  FACILITY NOTIFIED (B)(4) ON (B)(6) 2017 AND RELAYED THAT DURING A CASE THE BEAK BROKE OFF AND NO INJURIES HAD OCCURRED. (B)(4) SALES REPRESENTATIVE WAS CONTACTED AND INDICATED BEAK BROKE INTO PIECES HOWEVER THEY WERE RETRIEVED AND PROCEDURE COMPLETED AS SCHEDULED. THE REMOVAL OF THE FOREIGN OBJECTS CAUSE A DELAY IN THE PROCEDURE THAT MAY HAVE RESULTED IN PATIENT BEING AT RISK. (B)(4) ALSO RECEIVED A MEDWATCH REPORT ((B)(4)) ON 04/10/2017, INDICATING THAT DURING A HYSTEROSCOPY PROCEDURE DEVICE BROKE INSIDE OF BODY CAVITY. NO INJURIES TO PATIENT OR STAFF WERE REPORTED. NO SIMILAR ISSUES ON THIS DEVICE IN THE LAST THREE YEARS RESULTING IN A MEDICAL DEVICE REPORT. MANUFACTURE DATE : 08/2012. PURCHASE DATE: (B)(6) 2013. USER FACILITY WAS CONTACTED FOR MISSING AND ADDITIONAL INFORMATION ON SEVERAL OCCASIONS, NO INFORMATION RECEIVED AS OF 04/20/2017. (B)(4). (B)(4) CONSIDERS THIS REPORT CLOSED. IF ANY ADDITIONAL INFORMATION IS RECEIVED A FOLLOW UP REPORT WILL BE SENT.

  Patient problems: Foreign Body In Patient; No Consequences Or Impact To Patient

  MAUDE report 6508219 ↗