FDA Adverse Event
Malfunction
Summary report: N
UTERINE MANIPULATOR - 7CM
MDR report key: 2212797
·
Received August 16, 2011
Report
- Report Number
- 3005075853-2011-03326
- Event Type
- Malfunction
- Date Received
- August 16, 2011
- Date of Event
- July 22, 2011
- Report Date
- July 25, 2011
- Manufacturer
- ETHICON ENDO-SURGERY, LLC.
- Product Code
- LKF
- PMA / PMN Number
- K940681
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
(B)(4). INFORMATION IS UNAVAILABLE; DEVICE WAS NOT RETURNED FOR EVALUATION.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAPAROSCOPIC OOPHORECTOMY PROCEDURE, THAT THE BALLOON BURST DURING USE. THE SAME EVENT OCCURRED IN 2 DEVICES. NO PIECES WERE LEFT INSIDE THE PATIENT. ANOTHER DEVICE WAS USED TO COMPLETE THE CASE. THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT. USUALLY, 5 TO 8 CC WATER IS INJECTED INTO BALLOON AT THIS HOSPITAL. NO DEVICE WILL BE RETURNING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UTERINE MANIPULATOR - 7CM | LKF | ETHICON ENDO-SURGERY, LLC. | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |