MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-11-29 for GYNECARE X-TRACT MORCELLATOR MD0100 manufactured by Ethicon, Inc..
[21708492]
It was reported by the customer that, the motor drive unit would not spin when the foot pedal was pressed and that the front case was broken. There was no case involvement or pt consequence.
Patient Sequence No: 1, Text Type: D, B5
[21864902]
Conclusion: the actual unit involved in this event was returned for evaluation. The unit was visually examined and it was found that there was a broken barb on the pneumatic foot switch which prevents the start of the unit when using the foot pedal. It was also noted that the top case was cracked and the sub-chassis was bent under the motor, making the coupler wobble.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2006-00782 |
| MDR Report Key | 792131 |
| Report Source | 06 |
| Date Received | 2006-11-29 |
| Date of Report | 2006-10-31 |
| Date Facility Aware | 2006-10-01 |
| Report Date | 2006-10-31 |
| Date Mfgr Received | 2006-10-31 |
| Date Added to Maude | 2006-12-12 |
| 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 |
| Reporter Occupation | BIOMEDICAL ENGINEER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| 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 ST |
| 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 | LAPAROSCOPIC MORCELLATOR |
| Product Code | HFG |
| Date Received | 2006-11-29 |
| Returned To Mfg | 2006-11-13 |
| Model Number | NA |
| Catalog Number | MD0100 |
| Lot Number | 00480 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 779771 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | * SOMERVILLE NJ 088760151 US |
| Baseline Brand Name | GYNECARE X-TRACT MORCELLATOR |
| Baseline Generic Name | MORCELLATOR |
| Baseline Model No | NA |
| Baseline Catalog No | MD0100 |
| Baseline ID | NA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-11-29 |