FDA Adverse Event
Injury
Summary report: N
GYNECARE MORCELLEX TISSUE MORCELLATOR
MDR report key: 1173372
·
Received September 22, 2008
Report
- Report Number
- 2210968-2008-00838
- Event Type
- Injury
- Date Received
- September 22, 2008
- Date of Event
- August 21, 2008
- Report Date
- August 21, 2008
- Manufacturer
- ETHICON, INC.
- Product Code
- HET
- PMA / PMN Number
- K061050
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BLEEDING OCCURRED - CONCLUSION: THE INSTRUCTIONS FOR USE, WHICH ACCOMPANY EACH DEVICE, STATED THAT THE DEVICE IS "CONTRAINDICATED FOR USE ON VASCULARIZED TISSUE OR AS A DISSECTING TOOL. ALL TARGET TISSUES AND ORGANS MUST BE DEVASCULARIZED AND DISSECTED BEFORE MORCELLATION."
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A GYNECOLOGICAL PROCEDURE IN 2008. THE PATIENT'S UTERUS WAS VASCULAR AND LARGE WITH A WEIGHT OF APPROXIMATELY 1500 GRAMS. DURING THE PROCEDURE, AFTER FIFTEEN TO TWENTY MINUTES, THE CASE WAS CONVERTED TO AN OPEN PROCEDURE DUE TO BLEEDING. THE BLEEDING OCCURRED WHILE THE SURGEON WAS DEBULKING TO MAKE A SMALLER UTERUS. THE SURGEON OPINES THAT THE CAUSE OF THE BLEEDING WAS THAT THE UTERUS WAS NOT COMPLETELY DETACHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GYNECARE MORCELLEX TISSUE MORCELLATOR | LAPAROSCOPE, GYNECOLOGIC | HET | ETHICON, INC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |