PHOTONGUIDE, WIDE/FLAT
Received May 30, 2019 · Event occurred Apr 29, 2019
Report 0001811755-2019-01854 · MDR key 8655906
Device
Generic name
Light, Surgical, Carrier
Manufacturer
Stryker Instruments-kalamazooCatalog number
104015
Lot number
AB19011701
Product problems
- Break
- Break
Patient
Not reported
- No Consequences Or Impact To Patient
- No Consequences Or Impact To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE PHOTONBUIDE BROKE IN HALF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY, ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION.
Description of Event or Problem
IT WAS REPORTED THAT DURING A SURGICAL PROCEDURE AT THE USER FACILITY, THE PHOTONBUIDE BROKE IN HALF. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITHOUT A CLINICALLY SIGNIFICANT DELAY, ADVERSE CONSEQUENCES, OR MEDICAL INTERVENTION.
Additional Manufacturer Narrative
CORRECTION: D10; H3 ADDITIONAL INFORMATION: H6 H3 OTHER TEXT : NOT RETURNED.