MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-02-28 for EXAMINER 10 LIGHT manufactured by Steris Corporation - Montgomery.
[184683382]
A steris service technician arrived onsite to inspect the examiner 10 light and confirmed that the cover had been secured in place by the biomed department. No issue with the function or operation of the light was identified. The light was installed in 2006 making it approximately 13 years old and is not under steris service agreement. The user facility is responsible for all maintenance activities. No additional issues have been reported.
Patient Sequence No: 1, Text Type: N, H10
[184683383]
The user facility reported via user facility medwatch # (b)(4) that a plastic cover on their examiner 10 light detached and fell onto the table. No patient was present on the table at the time of the reported event. The report stated, "per biomed, loose tension screw on plastic cover. Tightened screw and verified the cover was secure. "
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2020-00015 |
| MDR Report Key | 9771496 |
| Report Source | USER FACILITY |
| Date Received | 2020-02-28 |
| Date of Report | 2020-02-28 |
| Date Mfgr Received | 2020-01-29 |
| Date Added to Maude | 2020-02-28 |
| 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 |
| Manufacturer Country | US |
| Manufacturer Phone | 3927453 |
| Manufacturer G1 | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Street | 2720 GUNTER PARK DRIVE EAST |
| Manufacturer City | MONTGOMERY, AL |
| Manufacturer Country | US |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | EXAMINER 10 LIGHT |
| Generic Name | LIGHT |
| Product Code | KZF |
| Date Received | 2020-02-28 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STERIS CORPORATION - MONTGOMERY |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY, AL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-02-28 |