FDA Adverse Event
Injury
Summary report: N
GYNECARE MORCELLEX* TISSUE MORCELLATOR
MDR report key: 3070869
·
Received April 22, 2013
Report
- Report Number
- 2210968-2013-04217
- Event Type
- Injury
- Date Received
- April 22, 2013
- Date of Event
- April 4, 2013
- Report Date
- April 4, 2013
- Manufacturer
- ETHICON, INC.
- Product Code
- HET
- PMA / PMN Number
- K100280
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FI
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - BLADE SEIZED/STOPPED. CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC ASSISTED VAGINAL HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE STOPPED WORKING. THE PHYSICIAN CONVERTED TO AN OPEN PROCEDURE TO COMPLETE THE CASE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 171549 | GYNECARE MORCELLEX* TISSUE MORCELLATOR | LAPAROSCOPE, GYNECOLOGIC | HET | ETHICON, INC. | NA | MT217335 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |