Illuminated Stepped Laser Probe, Curved With tapered tip for use in combinatio 7510.ALCRecalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08717872016122), received between Jun 29, 2017 and Feb 6, 2018 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device Operational Issue” (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. Apr 14, 2021Class IIOpen, Classified

   Barcode label extended expiration date. Barcode located at the short side of the outer box shows 2025-10-27 when scanned, while the correct expiry date is 2024-10-01

   Z-2097-2021 · Root cause: Process control · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2018Material Separation; Material Separation

  A REPORT HAS BEEN RECEIVED FROM (B)(6). WE RECEIVED A COMPLAINT WHERE THE PARTS CAME OFF FROM THE TAPERED JOINT. WE WOULD APPRECIATE IT IF YOU COULD INVESTIGATE. IT WAS REPORTED THAT THE TIP WAS BROKEN. THERE IS NO FURTHER INFORMATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7245315 ↗
• MalfunctionAug 8, 2017Environmental Particulates; Environmental Particulates

  THE FOLLOWING INCIDENT HAS BEEN REPORTED. A 23GA CURVED ILLUMINATION PROBE WAS DEFECTIVE. SMOKING AT THE TIP. THERE WAS NO PATIENT INJURY. THERE WAS NO USER INJURY. THE SMOKING WAS NOTICED IN THE EYE. THE CASE WAS COMPLETED WITH A NEW SEPARATE DORC PROBE WITHOUT FURTHER INCIDENT. THE SAMPLE IS AVAILABLE FOR AN EVALUATION.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6773404 ↗
• MalfunctionJun 29, 2017Device Operational Issue; Device Operational Issue

  WE RECEIVED A MEDWATCH REPORT 1222074-2017-00001. A BOX WAS CHECKED OFF OF AN ADVERSE EVENT. THE USER FACILITY HAS BEEN CONTACTED FOR FOLLOW UP INFORMATION. IT HAS BEEN LEARNED THIS WAS NOT AN ADVERSE EVENT. THE REPORTER CLARIFIED THAT THE INCIDENT WAS DETECTED PRIOR TO SURGERY WHEN SETTING UP THE MACHINE THE LIGHT TURNED ON ALERTING THAT IS WAS NOT DETECTING THE PROBE. THE DEVICE WAS NOT USED. THEY USED ALTERNATIVE DEVICES FOR THE SURGERY WITHOUT FURTHER INCIDENT. THERE IS NO SAMPLE TO EVALUATE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 6677806 ↗