FDA Adverse Event
Malfunction
Summary report: N
GYNECARE MORCELLEX TISSUE MORCELLATOR
MDR report key: 3212365
·
Received July 9, 2013
Report
- Report Number
- 2210968-2013-12516
- Event Type
- Malfunction
- Date Received
- July 9, 2013
- Date of Event
- June 25, 2013
- Report Date
- June 25, 2013
- Manufacturer
- ETHICON INC.
- Product Code
- HET
- PMA / PMN Number
- K100280
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- KY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CONCLUSION: NO CONCLUSION CAN BE DRAWN AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE OBTAINED, A SUPPLEMENTAL 3500A FORM WILL BE SUBMITTED ACCORDINGLY.
Additional Manufacturer Narrative · 1
(B)(4) - BLADE SEIZED/STOPPED. CONCLUSION: THE PRODUCT UPON WHICH THIS MEDWATCH IS BASED IS ANTICIPATED. ONCE THE PRODUCT IS RECEIVED, ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PATIENT UNDERWENT A LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY ON (B)(6) 2013. DURING THE PROCEDURE, THE DEVICE STOPPED FUNCTIONING. ANOTHER LIKE DEVICE WAS USED TO COMPLETE THE PROCEDURE WITH NO ADVERSE PATIENT CONSEQUENCES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 312267 | GYNECARE MORCELLEX TISSUE MORCELLATOR | LAPAROSCOPE, GYNECOLOGIC (AND ACCESSORIES) | HET | ETHICON INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |