MAGNIFYING LPE 2.5X RED R 12IN TO 15IN WRKG DIST
Received Jun 21, 2022
Report 3014334038-2022-00124 · MDR key 14751103
Device
Generic name
M5 - General Surgery
Manufacturer
Integra Lifesciences MansfieldModel number
1-5001Catalog number
1-5001
Lot number
W2102005
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MAGNIFYING LOUPE, 2.5X RED FRAME, 12IN TO 15IN WORKING DISTANCE (1-5001) WAS RETURNED FOR EVALUATION. DEVICE HISTORY RECORD: NO ABNORMALITIES RELATED TO THE REPORTED ISSUE WERE IDENTIFIED. FAILURE ANALYSIS: EVALUATION OF THE RETURNED MAGNIFYING LOUPE FOUND THE DEVICE WAS IN USED CONDITION WITH THE ADJUSTMENT KNOBS DISCONNECTED. ROOT CAUSE ANALYSIS: THE COMPLAINT REPORTED BY THE CUSTOMER WAS CONFIRMED. THE RETURNED MAGNIFYING LOUPE HAD ITS ADJUSTMENT KNOB BROKEN OFF DUE TO ROUGH HANDLING/ENVIRONMENTAL DAMAGE. NO MANUFACTURING, WORKMANSHIP OR MATERIAL DEFICIENCY HAS BEEN IDENTIFIED. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.
Description of Event or Problem
IT WAS REPORTED THAT THE UP AND DOWN MECHANISM OF THE MAGNIFYING LOUPE (1-5001) WAS NOT WORKING. NO PATIENT INJURY, DEATH OR SURGICAL DELAY WAS REPORTED.