E-LINE 86880145Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 04055207028575), received between Feb 26, 2021 and Feb 26, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryFeb 26, 2021Break; Break

  RESULTS OF THE DEVICE EVALUATION REVEALED: THE CUSTOMER REPORTS DAMAGE TO THE PRODUCT THAT OCCURRED DURING USE. THE DAMAGE INVOLVES THE DETACHMENT AND BREAKAGE OF THE INSULATING INSERT (CERAMIC SLEEVE) AT THE DISTAL END OF THE SHAFT OF A 9CH RESECTOSCOPE TYPE 8688.0145. THE INSULATING INSERT COMPLETELY DETACHED FROM THE SHAFT, AS WELL AS A SMALLER FRAGMENT, HAD TO BE RECOVERED FROM THE PATIENT'S URINARY BLADDER BY THE USER. THE INSULATING INSERT, AS WELL AS A SMALLER FRAGMENT, COULD BE SUCCESSFULLY RECOVERED FROM THE PATIENT'S URINARY BLADDER WITH THE AID OF FORCEPS. GRIT OR SMALLER CONCRETIONS WERE DRAINED FROM THE BLADDER VIA AN 8CH BLADDER BALLOON CATHETER AFTER DISCONTINUATION OF THE PROCEDURE. THE PRODUCT IS A SHAFT FOR RESECTOSCOPE 9CH, TYPE NUMBER 8688.0145 FROM LOT 1286350 - RECORDED ON 02/03/2021 WITH CLAIM NUMBER 700015717. THE PRODUCT WAS SHIPPED TO THE CUSTOMER ON 10/21/2015. PLEASE SEE MANUFACTURERS NARRATIVE FOR ADDITIONAL INFORMATION.

  Patient problems: Insufficient Information

  MAUDE report 11385349 ↗