MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2013-02-19 for BATTERY OSCILLATOR 530.610 manufactured by Synthes Gmbh.
[3183466]
It is reported that a battery oscillator stopped working during a total hip surgery. There was no patient injury, no user injury and no delay in surgery. This is 1 of 1 reports for this event.
Patient Sequence No: 1, Text Type: D, B5
[10512049]
Device was used for treatment, not diagnosis. Reliability engineering evaluated the device, and the reported problem was confirmed; the device was tested and would not engage when power was applied. The unit exhibited damage to the motor and ecu that was consistent with immersion in water. This condition is indicative of improper cleaning of the device. We recommend that the user review the cleaning and maintenance procedures for the device. Proper cleaning and maintenance are required in order to ensure trouble-free operation. The manufacturing documents were reviewed and no complaint related issues were found.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 8030965-2013-00515 |
| MDR Report Key | 2967957 |
| Report Source | 05,07 |
| Date Received | 2013-02-19 |
| Date of Report | 2012-11-29 |
| Date of Event | 2012-11-29 |
| Date Mfgr Received | 2012-11-29 |
| Device Manufacturer Date | 2008-02-02 |
| Date Added to Maude | 2013-04-30 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | KUBA ZAROBKIEWICZ |
| Manufacturer Street | 1302 WRIGHTS LANE EAST |
| Manufacturer City | WEST CHESTER PA 19380 |
| Manufacturer Country | US |
| Manufacturer Postal | 19380 |
| Manufacturer Phone | 8006207025 |
| Manufacturer G1 | SYNTHES GMBH |
| Manufacturer Street | EIMATTSTRASSE 3 CH-4436 |
| Manufacturer City | OBERDORF |
| Manufacturer Country | SZ |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BATTERY OSCILLATOR |
| Generic Name | BATTERY OSCILLATOR |
| Product Code | FCO |
| Date Received | 2013-02-19 |
| Catalog Number | 530.610 |
| Lot Number | 3616 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYNTHES GMBH |
| Manufacturer Address | EIMATTSTRASSE 3 CH-4436 OBERDORF SZ |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-19 |