FDA Adverse Event
Malfunction
Summary report: N
GYNECARE X-TRACT MORCELLATOR
MDR report key: 948833
·
Received November 16, 2007
Report
- Report Number
- 2210968-2007-01050
- Event Type
- Malfunction
- Date Received
- November 16, 2007
- Report Date
- October 19, 2007
- Manufacturer
- ETHICON, INC.
- Product Code
- HET
- PMA / PMN Number
- K993801
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- VA, US
- Reporter Occupation
- BIOMEDICAL ENGINEER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 11/16/2007. CONCLUSION: THE ACTUAL DEVICE INVOLVED IN THIS EVENT WAS RETURNED FOR EVALUATION. THE FUNCTIONAL EVALUATION COULD NOT DUPLICATE THE REPORTED COMPLAINT SYMPTOM. THE UNIT FUNCTIONED AS REQUIRED WITH THE TEST HANDPIECE AND THE TORQUE STALL.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNKNOWN DATE. DURING THE PROCEDURE, THE MOTOR DRIVE UNIT WAS BOGGING DOWN. THE CASE WAS SUCCESSFULLY COMPLETED WITH A SECOND MOTOR DRIVE UNIT WITH NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GYNECARE X-TRACT MORCELLATOR | LAPAROSCOPIC MORCELLATOR | HET | ETHICON, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK YR |