MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2007-05-17 for GYNECARE X-TRACT MORCELLATOR MD0100-US manufactured by Ethicon, Inc..
[18877777]
No conclusion can be drawn at this time. Should additional information be obtained, a supplemental 3500a form will be submitted accordingly.
Patient Sequence No: 1, Text Type: N, H10
[18966456]
It was reported by the customer, that the front cpc connector on the motor drive unit appeared worn. It was unknown by the customer, if there was any patient or case involvement. There was no known patient consequences.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2210968-2007-00502 |
| MDR Report Key | 851717 |
| Report Source | 05,06 |
| Date Received | 2007-05-17 |
| Date of Report | 2007-04-17 |
| Report Date | 2007-04-17 |
| Date Mfgr Received | 2007-04-17 |
| Date Added to Maude | 2007-05-24 |
| 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 | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. LUIS BLANCO |
| Manufacturer Street | ROUTE 22 WEST P.O. BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082183002 |
| Manufacturer G1 | HEI, INC. |
| Manufacturer Street | 4801 N. 63RD STREET |
| Manufacturer City | BOULDER CO 80301 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 80301 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | GYNECARE X-TRACT MORCELLATOR |
| Generic Name | MOTOR DRIVE UNIT |
| Product Code | HFG |
| Date Received | 2007-05-17 |
| Model Number | NA |
| Catalog Number | MD0100-US |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 840094 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2007-05-17 |