MAGNIFYING LPE 2.5X RED L 14IN TO 17IN WRKG DIST
Received Sep 26, 2019 · Event occurred Sep 16, 2019
Report 2523190-2019-00116 · MDR key 9126966
Device
Product problems
- Break
- Break
Patient
Not reported
- No Patient Involvement
- No Patient Involvement
Narrative
Additional Manufacturer Narrative
THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS. THE PLANT INVESTIGATION IS IN PROGRESS AND A SUPPLEMENTAL MEDWATCH REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.
Description of Event or Problem
A CUSTOMER REPORTED THAT ON (B)(6) 2019, THE 1-5002 MAGNIFYING LPE 2.5X RED L 14IN TO 17IN WRKG DIST WAS BROKEN. THERE WAS NO PATIENT CONTACT, INJURY OR SURGICAL DELAY REPORTED.
Additional Manufacturer Narrative
UDI INFORMATION: (B)(4). THE RETURNED GLASSES WERE RETURNED SHOWING WEAR AND ONE OF THE ARMS WAS BROKEN OFF. THE LOUPES WERE INTACT. THE COMPLAINT REPORT HAS BEEN CONFIRMED; DAMAGED WORN. THE ROOT CAUSE HAS NOT BEEN IDENTIFIED AS A WORKMANSHIP OR MATERIAL DEFICIENCY.