FDA Adverse Event
Malfunction
Summary report: N
GYNECARE MORCELLEX TISSUE MORCELLATOR
MDR report key: 1070588
·
Received July 2, 2008
Report
- Report Number
- 2210968-2008-00489
- Event Type
- Malfunction
- Date Received
- July 2, 2008
- Date of Event
- May 27, 2008
- Report Date
- June 5, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- HET
- PMA / PMN Number
- K061050
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NL
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DATE SENT TO THE FDA: 7/2/08. BLADE SEIZED/STOPPED - CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVAL IS NOT YET COMPLETE. ANY FURTHER INFO DERIVED FROM THE EVAL WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. DURING THE PROCEDURE, AFTER THIRTY MINUTES OR MORCELLATING, THE DEVICE DID NOT WORK ANYMORE. THE BLADE COULD NOT BE ACTIVATED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH A SECOND DEVICE WITH NO ADVERSE PT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GYNECARE MORCELLEX TISSUE MORCELLATOR | LAPAROSCOPE, GYNECOLOGIC | HET | ETHICON, INC. | NA | MT210746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |