FDA Adverse Event
Malfunction
Summary report: N
GYNECARE X-TRACT MORCELLATOR
MDR report key: 1990062
·
Received January 28, 2011
Report
- Report Number
- 2210968-2011-00073
- Event Type
- Malfunction
- Date Received
- January 28, 2011
- Report Date
- December 29, 2010
- Manufacturer
- ETHICON, INC.
- Product Code
- HET
- PMA / PMN Number
- K993801
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4) - DAMAGE TO DRIVE CONNECTOR OR COUPLING. 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. IN ADDITION, A REVIEW OF THE DEVICE MANUFACTURING RECORDS WAS CONDUCTED AND THE DEVICE MET ALL FINISHED GOODS RELEASE CRITERIA.
Description of Event or Problem · 1
IT WAS REPORTED THAT A PT UNDERWENT A GYNECOLOGICAL PROCEDURE ON AN UNK DATE. DURING THE PROCEDURE, THE USER HAD TO HOLD THE DISPOSABLE HANDPIECE AT THE CONNECTOR TO GET IT TO OPERATE CORRECTLY. THERE WERE NO ADVERSE PT CONSEQUENCES REPORTED.
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 |