N
Patient 1
(B)(4). MANUFACTURING SITE EVALUATION: EVALUATION ON GOING.
MAUDE MDR 5234114
- MDR report key
- 5234114
- Report number
- 2916714-2015-01037
- Event key
- 0
- Event type
- 3
- Date received
- 2015-11-18
- Adverse event
- 3
- Product problem
- 3
- Patients in event
- 0
- Reporter occupation
- 0
- Health professional
- 3
- Initial report to FDA
- 3
- Event location
- 3
Manufacturer Contact#
- Contact
- MS. NICOLE BROYLES
- Address
- 615 LAMBERT POINTE DRIVE HAZELWOOD MO 63042 US
- Phone
- 314-314-3145
- Report source
- M
- Manufacturer link flag
- Y
Devices#
| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | AXEL XENON LIGHT SOURCE 180W | COLD LIGHT FOUNTAINS | AESCULAP AG | FSS | OP930 | OP930 | 51389276 | Y | * |
Patients#
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-18 | 0 | 1. O |
Event Narratives#
D
Patient 1
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 .
N
Patient 1
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.