MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2006-10-17 for GYNECARE X-TRACT MORCELLATOR DV0015 manufactured by Ethicon, Inc..
[613548]
It was reported that the tissue morcellator would not cut. The device was returned and the eval revealed that, the sheath was stuck in the cut position with the blade exposed. No adverse pt consequences were reported.
Patient Sequence No: 1, Text Type: D, B5
[7957569]
Conclusion: the actual device was returned for eval and the device will not function per the requirement. The cut/no cut button does turn but, the outer sheath stays in the cut position. The gray drive box connector that plugs into the mdu is broken. The device was disassembled and noted that the front collar on the end of the outer sheath has broken free from the outersheath and is no longer adhered, however, there is evidence that the front collar had adhesive applied to it. Visual inspection on the cutter tube shows that the cutting edge has been dulled and rolled over. The cutting edge has wear and damage which would be consistent with what occurs when cutting calcified tissue. The inner sheath and cutter tube are frozen together with dried fluid.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2006-00688 |
| MDR Report Key | 854018 |
| Report Source | 06 |
| Date Received | 2006-10-17 |
| Date of Report | 2006-09-18 |
| Date Facility Aware | 2006-08-07 |
| Report Date | 2006-08-07 |
| Date Mfgr Received | 2006-09-18 |
| Date Added to Maude | 2007-05-23 |
| 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 | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. LUIS BLANCO |
| Manufacturer Street | ROUTE 22 WEST, PO BOX 151 |
| Manufacturer City | SOMERVILLE NJ 088760151 |
| Manufacturer Country | US |
| Manufacturer Postal | 088760151 |
| Manufacturer Phone | 9082183002 |
| Manufacturer G1 | ACCELLENT |
| Manufacturer Street | 45 LEXINGTON DR |
| Manufacturer City | LACONIA NH 03246 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 03246 |
| 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 | MORCELLATOR |
| Product Code | HFG |
| Date Received | 2006-10-17 |
| Returned To Mfg | 2006-08-14 |
| Model Number | NA |
| Catalog Number | DV0015 |
| Lot Number | MS1205026 |
| 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 | 839629 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | * SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-10-17 |