MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2018-01-25 for HARMONY VLED SURIGICAL LIGHTING SYSTEM manufactured by Steris Corporation - Montgomery.
[98577230]
A steris technician arrived onsite to inspect the lighting system. The technician found that the plastic yoke cover had detached from the lighting system and that both screws were still intact with the plastic yoke cover assembly. The technician also observed cracks and abrasions on the surface of the lighting system. The harmony vled surgical lighting system operator manual states (pg. 1-4), "do not bump light heads into walls or other equipment. Use care when moving the arm upward to help avoid hitting the ceiling or objects above the arm. " the technician replaced the plastic cover for the subject vled surgical lighting system, confirmed the unit to be operating properly, and returned the unit to service. The reported event can be attributed to impact damage due to the lighthead bumping into other equipment or light heads. The lighting system was installed in 2011 and the unit has been in use for approximately 7 years. No additional issues have been noted.
Patient Sequence No: 1, Text Type: N, H10
[98577271]
The user facility reported that the plastic yoke cover on their harmony vled surgical lighting system into the sterile field during a procedure. User facility personnel re-established the sterile field and the procedure was successfully completed without further incident. No report of injury.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2018-00010 |
| MDR Report Key | 7220392 |
| Date Received | 2018-01-25 |
| Date of Report | 2018-01-25 |
| Date of Event | 2017-12-29 |
| Date Mfgr Received | 2017-12-29 |
| Date Added to Maude | 2018-01-25 |
| 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. DANIEL DAVY |
| Manufacturer Street | 5960 HEISLEY ROAD |
| Manufacturer City | MENTOR OH 44060 |
| Manufacturer Country | US |
| Manufacturer Postal | 44060 |
| Manufacturer Phone | 4403927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 36109 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | HARMONY VLED SURIGICAL LIGHTING SYSTEM |
| Generic Name | LIGHTING SYSTEM |
| Product Code | FST |
| Date Received | 2018-01-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US 36109 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-01-25 |