FDA Adverse Event
Injury
Summary report: N
KRONNER MANIPUJECTOR
MDR report key: 2494551
·
Received May 17, 2011
Report
- Report Number
- 1216677-2011-00007
- Event Type
- Injury
- Date Received
- May 17, 2011
- Date of Event
- March 17, 2011
- Report Date
- May 16, 2011
- Manufacturer
- COOPERSURGICAL, INC.
- Product Code
- LKF
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
KRONNER MANIPUJECTOR WAS NOT RETURNED TO COOPERSURGICAL, INC. FOR EVALUATION. A PRODUCT QUERY FOR PRODUCT# (B)(4) REVEALED NO APPARENT TREND. COOPERSURGICAL, INC. HAS RECEIVED NO OTHER COMPLAINTS FOR LOT# 96787. (B)(4).
Description of Event or Problem · 1
PT UNDERGOING LAPAROSCOPIC SUPRACERVICAL HYSTERECTOMY. UPON REMOVAL OF THE MANIPUJECTOR, THE TIP WAS NOTED TO BE MISSING. A CYSTOSCOPY WAS PERFORMED AND THE DISTAL TIP WAS IDENTIFIED IN THE URINARY BLADDER WITH THE BALLOON DEFLATED. IT WAS REMOVED AND NO INJURY WAS NOTED IN THE BLADDER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KRONNER MANIPUJECTOR | NONE | LKF | COOPERSURGICAL, INC. | 96787 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |