MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,06,07 report with the FDA on 2007-10-26 for MPOWER TWO TRIGGER MODULAR HANDPIECE PRO6202 manufactured by Conmed Linvatec.
[712938]
The customer returned this handpiece for service with the report that it operated erratically. There was no report of injury or surgical delay associated with this event.
Patient Sequence No: 1, Text Type: D, B5
[8115779]
Investigation findings: this handpiece was received for evaluation and the reported problem was confirmed. During testing of this handpiece, it ran slow and would hesitate. In addition, the unit was found to have the potential to run in the safe mode related to controller failure. An investigation remains in process for this failure mode. Conmed linvatec will continue to monitor this product for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2007-00722 |
| MDR Report Key | 934302 |
| Report Source | 00,06,07 |
| Date Received | 2007-10-26 |
| Date of Report | 2007-10-01 |
| Date of Event | 2007-10-01 |
| Date Mfgr Received | 2007-10-01 |
| Device Manufacturer Date | 2005-11-17 |
| Date Added to Maude | 2007-12-19 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | BEVERLY SCHANER |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal | 33773 |
| Manufacturer Phone | 7273995169 |
| Manufacturer G1 | CONMED LINVATEC |
| Manufacturer Street | 11311 CONCEPT BLVD. |
| Manufacturer City | LARGO FL 33773 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 33773 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | MPOWER TWO TRIGGER MODULAR HANDPIECE |
| Generic Name | BATTERY HANDPIECE |
| Product Code | FCO |
| Date Received | 2007-10-26 |
| Returned To Mfg | 2007-10-01 |
| Model Number | NA |
| Catalog Number | PRO6202 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 927115 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-10-26 |