MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06,07 report with the FDA on 2007-02-27 for GYNECARE X-TRACT MORCELLATOR MD0100 manufactured by Ethicon, Inc..
[592072]
It was reported that a patient underwent a laparoscopic hysterectomy in 2007. After forty-five minutes into the procedure, the unit became slow and fifteen minutes later, the unit stopped working. There was no longer any power getting to the mdu. The procedure was converted to a laparotomy and was successfully completed without further consequence to the pt. The procedure was delayed forty-five minutes.
Patient Sequence No: 1, Text Type: D, B5
[7873042]
Conclusion: the actual device was returned for evaluation. Functional testing found a defective power supply.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2007-00350 |
| MDR Report Key | 833219 |
| Report Source | 01,05,06,07 |
| Date Received | 2007-02-27 |
| Date of Report | 2007-02-27 |
| Date of Event | 2007-02-27 |
| Date Facility Aware | 2007-02-27 |
| Report Date | 2007-02-27 |
| Date Mfgr Received | 2007-02-27 |
| Date Added to Maude | 2007-04-03 |
| 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 | 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 | 2007-02-27 |
| Model Number | NA |
| Catalog Number | MD0100 |
| Lot Number | HEI03790 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 820527 |
| 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 | 1. Required No Informationntervention | 2007-02-27 |