MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a company representative,distri report with the FDA on 2018-02-12 for CAMERA CONTROL UNIT, HIGH DEF, 560P 72201919 manufactured by Smith & Nephew, Inc..
[99993341]
(b)(6).
Patient Sequence No: 1, Text Type: N, H10
[99993342]
It was reported that the device had a burning smell and smoke comingout. There was no delay or patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[135423715]
The device was received for evaluation. There was a relationship found between the returned device and the reported incident. A visual inspection was performed on the product and no issue was observed. Complaint of smoke and burnt odor was caused by a large capacitor on the power supply which split open and emitted a resinous material when unit overheated. Ccu still passes functional testing and 6 hour burn-in but the power supply needs to be replaced. A review of the device history records showed there were no indications to suggest that the product did not meet manufacturing specification or would not be able to perform as intended.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1643264-2018-00125 |
| MDR Report Key | 7263131 |
| Report Source | COMPANY REPRESENTATIVE,DISTRI |
| Date Received | 2018-02-12 |
| Date of Report | 2018-03-23 |
| Date Mfgr Received | 2018-03-21 |
| Date Added to Maude | 2018-02-12 |
| 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 | JIM GONZALES |
| Manufacturer Street | 7000 WEST WILLIAM CANNON DRIVE |
| Manufacturer City | AUSTIN TX 78735 |
| Manufacturer Country | US |
| Manufacturer Postal | 78735 |
| Manufacturer G1 | SMITH & NEPHEW, INC. |
| Manufacturer Street | 76 S. MERIDIAN AVE. |
| Manufacturer City | OKLAHOMA CITY OK 731076512 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 731076512 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | CAMERA CONTROL UNIT, HIGH DEF, 560P |
| Generic Name | LIGHT SOURCE, ENDOSCOPE, XENON ARC |
| Product Code | GCT |
| Date Received | 2018-02-12 |
| Model Number | 72201919 |
| Catalog Number | 72201919 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SMITH & NEPHEW, INC. |
| Manufacturer Address | 76 S. MERIDIAN AVE. OKLAHOMA CITY OK 731076512 US 731076512 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-02-12 |