GYNECARE X-TRACT MORCELLATOR Adverse Event — Malfunction (MDR 2210968-2008-00095)
GYNECARE X-TRACT MORCELLATOR Adverse Event — Malfunction (MDR 2210968-2008-00095) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: GYNECARE X-TRACT MORCELLATOR; Generic name: LAPAROSCOPIC MORCELLATOR; Manufacturer: ETHICON, INC..
| Device | GYNECARE X-TRACT MORCELLATOR |
|---|---|
| Generic name | LAPAROSCOPIC MORCELLATOR |
| Manufacturer | ETHICON, INC. |
| Report number | 2210968-2008-00095 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-21 |
| Report source | Health Professional, User facility, Company representation |
| Narrative | IT WAS REPORTED THAT A PT UNDERWENT GYNECOLOGICAL PROCEDURE IN 2007. DURING THE PROCEDURE, THE MOTOR DRIVE SHUT DOWN AND THEN WOULD RESTART THEN SHUT DOWN AGAIN. THE MOTOR DRIVE UNIT WAS REPORTED TO HAVE OVERHEATED DURING THE PROCEDURE, STOPPING THE INSTRUMENT FROM FUNCTIONING. THE CUSTOMER NEEDED TO LET THE UNIT COOL DOWN FOR A FEW MINS THEN CONTINUE WITH THE CASE. IT IS UNK HOW THE CASE WAS COMP |
| Source | openFDA MAUDE (device adverse events) |
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