FDA Adverse Event
Injury
Summary report: N
LAPAROSCOPIC BOWEL CLAMP
MDR report key: 1659042
·
Received April 9, 2010
Report
- Report Number
- 1659042
- Event Type
- Injury
- Date Received
- April 9, 2010
- Date of Event
- March 23, 2010
- Report Date
- April 5, 2010
- Manufacturer
- KARL STORZ
- Product Code
- GEN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- NC, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
ON (B)(6) 2010, THE PT WAS UNDERGOING A LAPAROSCOPIC ROBOTIC ASSISTED MYOMECTOMY. DURING THE PROCEDURE ONE JAW OF THE BOWEL GRASPER BROKE AND FELL INTO THE ABDOMEN. THE SURGEON LOCATED THE BROKEN PIECE AND SUCCESSFULLY REMOVED THE PIECE USING A LAPAROSCOPIC MAGNET.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | LAPAROSCOPIC BOWEL CLAMP | GRASPING FORCEPS | GEN | KARL STORZ |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 37 YR | Required Intervention |