MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2010-06-17 for CL300 SFI SURGICAL HEADLIGHT SYSTEM 90123 manufactured by Welch Allyn.
[1343169]
On (b)(6) 2010, welch allyn was informed that a (b)(6) male pt undergoing an inguinal hernial repair procedure, allegedly received an 1cm blister on his abdomen. The attending physician was using a fiber optic surgical headlight system to illuminate the region of interest on the pt during the surgery. The pt's skin had been prepped with betadine and draped, a small portion of the abdomen was exposed and it was this exposed area of the abdomen where the blister/burn occurred; bacitracin ointment was applied to the blister/burn. The customer did not provide a pt identifier.
Patient Sequence No: 1, Text Type: D, B5
[8620026]
The customer returned the cl300 headlight system to welch allyn for eval. Functional and optical testing, as performed by welch allyn, did not indicate that the cl300 was the likely cause of the pt blister/burn. The ultraviolet (uv) filters were in place and functional. The lamp output power was measured and found to be low: 112 lumens versus new lamp specification of 400 - 450 lumens average. The system's spectral output was evaluated and found to be 34% of the control device: the sum of uv (250-380 nm) power of the event cl300 was 4 x 10-6 w/cm2, while that of the control device was 1. 3 x 10-5 w/cm2.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1316463-2010-00004 |
| MDR Report Key | 1731266 |
| Report Source | 05 |
| Date Received | 2010-06-17 |
| Date of Report | 2010-05-18 |
| Date of Event | 2010-05-18 |
| Date Mfgr Received | 2010-05-18 |
| Device Manufacturer Date | 2008-02-01 |
| Date Added to Maude | 2010-06-24 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | PEARLEY BHAMBRI, SR. MGR |
| Manufacturer Street | 4341 STATE ST. RD. |
| Manufacturer City | SKANEATELES FALLS NY 131530220 |
| Manufacturer Country | US |
| Manufacturer Postal | 131530220 |
| Manufacturer Phone | 3156852568 |
| Manufacturer G1 | WELCH ALLYN |
| Manufacturer Street | 4619 JORDAN RD |
| Manufacturer City | SKANEATELES FALLS NY 13153 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 13153 |
| Single Use | 3 |
| Remedial Action | IN |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CL300 SFI SURGICAL HEADLIGHT SYSTEM |
| Product Code | FJC |
| Date Received | 2010-06-17 |
| Model Number | 90123 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | WELCH ALLYN |
| Manufacturer Address | 4619 JORDAN RD SKANEATELES FALLS NY 13153 US 13153 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2010-06-17 |