BIHLERMED SURGICAL LIGHT
Received Dec 9, 2024 · Event occurred Nov 14, 2024
Report 3005977121-2024-00002 · MDR key 20880800
Device
Generic name
Surgical Lamp
Manufacturer
Bihlermed, LlcModel number
2762-01-0004Catalog number
2762-01-0004
Lot number
12177
Product problems
- Detachment of Device or Device Component
- Detachment of Device or Device Component
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE ORIGINAL NOTIFICATION INDICATED THAT THE DEVICE WAS DISCARDED BY THE CUSTOMER AND THEREFORE COULD NOT BE RETURNED. A PICTURE OF THE DEVICE WAS REQUESTED BY BIHLERMED AND PROVIDED ON (B)(6) 2024. THE PICTURE SHOWS THAT THE LENS IS MISSING FROM ONE TIP OF A DUAL STRAIGHT TIP (2762-01-0004). THERE APPEARS TO BE DAMAGE, A DARK SPOT ON LEFT SIDE, TO THE LED AND SOME DISCOLORATION OF THE METAL IN THE SAME REGION, BUT IT IS UNCLEAR IF THIS DAMAGE COULD HAVE LEAD TO THE LENS DISLODGEMENT. IT IS ALSO UNCLEAR ON WHAT CAUSED THE ORIGINAL DAMAGE.
Description of Event or Problem
IT WAS REPORTED THAT THE LENS TIP OF THE SURGICAL LIGHT WAS MISSING AFTER THE SURGERY. THERE WERE NO FURTHER COMPLICATIONS REPORTED REGARDING THE EVENT.