FDA Adverse Event
Malfunction
Summary report: N
BIHLERMED SURGICAL LIGHT
MDR report key: 20880800
·
Received December 9, 2024
Report
- Report Number
- 3005977121-2024-00002
- Event Type
- Malfunction
- Date Received
- December 9, 2024
- Date of Event
- November 14, 2024
- Report Date
- December 9, 2024
- Manufacturer
- BIHLERMED, LLC
- Product Code
- FTD
- UDI-DI
- 10865082000150
- PMA / PMN Number
- K133425
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 0
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 · 0
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.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2533411 | BIHLERMED SURGICAL LIGHT | SURGICAL LAMP | FTD | BIHLERMED, LLC | 2762-01-0004 | 12177 | 10865082000150 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |