MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,foreig report with the FDA on 2015-11-18 for AXEL XENON LIGHT SOURCE 180W OP930 manufactured by Aesculap Ag.
[31571915]
(b)(4). Manufacturing site evaluation: evaluation on going.
Patient Sequence No: 1, Text Type: N, H10
[31571916]
Country of complaint: (b)(6). The original fault appeared allegedly again, after the repair was carried out. The problem appears when the product is turned off after a longer application and then switched on again. The light source then does not start to work any more. The bulb was fairly often replaced. The device interestingly enough works again after it is turned off for some time (cooling? ). It has happened several times while a patient was already under anesthesia in which the surgeon then could not start with arthroscopy, because of the defective device.
Patient Sequence No: 1, Text Type: D, B5
[53955203]
The light source arrived without any visible damages. The light source was tested and the described failure was confirmed. For further analysis the electronic module was sent to the manufacturer. A review of the device quality and manufacturing history records was not possible because the power/ignition unit is a purchased part. According to the supplier the root cause for the behavior of the power/ignition unit was defective capacitors and ignition sparks gap. Corrective/preventive action not required. Additional information: lot number, device manufacture date.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2916714-2015-01037 |
| MDR Report Key | 5234114 |
| Report Source | COMPANY REPRESENTATIVE,FOREIG |
| Date Received | 2015-11-18 |
| Date of Report | 2016-08-01 |
| Date Facility Aware | 2015-11-04 |
| Date Mfgr Received | 2016-06-16 |
| Device Manufacturer Date | 2007-01-23 |
| Date Added to Maude | 2015-11-18 |
| 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 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MS. NICOLE BROYLES |
| Manufacturer Street | 615 LAMBERT POINTE DRIVE |
| Manufacturer City | HAZELWOOD MO 63042 |
| Manufacturer Country | US |
| Manufacturer Postal | 63042 |
| Manufacturer Phone | 3145515988 |
| Manufacturer G1 | AESCULAP AG |
| Manufacturer Street | PO BOX 40 |
| Manufacturer City | TUTTLINGEN, 78501 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78501 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AXEL XENON LIGHT SOURCE 180W |
| Generic Name | COLD LIGHT FOUNTAINS |
| Product Code | FSS |
| Date Received | 2015-11-18 |
| Model Number | OP930 |
| Catalog Number | OP930 |
| Lot Number | 51389276 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | * |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | AESCULAP AG |
| Manufacturer Address | PO BOX 40 TUTTLINGEN, 78501 GM 78501 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2015-11-18 |