MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 00,01,06,07 report with the FDA on 2008-02-14 for MPOWER TWO TRIGGER MODULAR HANDPIECE PRO6202 manufactured by Conmed Linvatec.
[794955]
The customer noted during pre-operative testing, that the device trigger would lock up, and the handpiece would run in the safe mode. There was no report of serious injury or surgical delay related to this event.
Patient Sequence No: 1, Text Type: D, B5
[7935757]
Investigation findings: conmed linvatec received this handpiece for evaluation and confirmed the reported problem. During testing, the evaluator found this device has the potential to operate in the safe mode when the trigger is depressed, related to controller failure. A design change to the controller has been implemented for this failure. There are no serious injuries related to this failure mode. Conmed linvatec will continue to monitor this device for failures.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1017294-2008-00107 |
| MDR Report Key | 1001069 |
| Report Source | 00,01,06,07 |
| Date Received | 2008-02-14 |
| Date of Report | 2008-01-16 |
| Date Mfgr Received | 2008-01-16 |
| Device Manufacturer Date | 2006-08-01 |
| Date Added to Maude | 2008-04-29 |
| 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 | 2008-02-14 |
| Returned To Mfg | 2008-01-18 |
| Model Number | NA |
| Catalog Number | PRO6202 |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 999980 |
| Manufacturer | CONMED LINVATEC |
| Manufacturer Address | LARGO FL US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2008-02-14 |