MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2006-09-08 for GYNECARE X-TRACT MORCELLATOR MD0100 manufactured by Ethicon, Inc..
[16372463]
It was reported that the patient underwent a laparoscopic-assisted supracervical hysterectomy in 2006. The morcellator was making a grinding noise and wouldn't operate during the procedure. The customer tried to re-seat the morcellator into the motor drive unit, and the grinding noise continued. Another morcellator was pulled and they encountered the same issue. The procedure was converted to a colpotomy and was successfully completed with no adverse patient outcome.
Patient Sequence No: 1, Text Type: D, B5
[16485483]
Conclusion: the product upon which this medwatch is based has been received, however, the product evaluation is not yet complete. Any further information derived from the evaluation will be submitted in a supplemental 3500a form.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2210968-2006-00602 |
| MDR Report Key | 758632 |
| Report Source | 05,06 |
| Date Received | 2006-09-08 |
| Date of Report | 2006-08-09 |
| Date of Event | 2006-08-09 |
| Date Facility Aware | 2006-08-09 |
| Report Date | 2006-08-09 |
| Date Mfgr Received | 2006-08-09 |
| Date Added to Maude | 2006-09-12 |
| 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 |
| 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 | 2006-09-08 |
| Returned To Mfg | 2006-08-21 |
| Model Number | NA |
| Catalog Number | MD0100 |
| Lot Number | NA |
| ID Number | UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 746557 |
| Manufacturer | ETHICON, INC. |
| Manufacturer Address | * SOMERVILLE NJ 088760151 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2006-09-08 |