FDA Adverse Event
Injury
Summary report: N
ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12MM DIAMETER,100 MM LENGTH
MDR report key: 1002980
·
Received February 4, 2008
Report
- Report Number
- 1527736-2008-00672
- Event Type
- Injury
- Date Received
- February 4, 2008
- Date of Event
- January 10, 2008
- Report Date
- January 11, 2008
- Manufacturer
- ETHICON ENDO-SURGERY, INC. (CINCINNATI)
- Product Code
- GCJ
- PMA / PMN Number
- K032676
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME.
Description of Event or Problem · 1
IT WAS REPORTED THAT DURING A LAP GYN PROCEDURE, THE TOP SEAL WAS REMOVED AND THE SPONGE DISLODGED THE INNER SEAL CAUSING IT TO FALL INTO THE PATIENT'S ABDOMEN. THE SURGEON WAS UNAWARE THE PIECE FELL INTO THE PATIENT. THERE WAS BLEEDING AND THE SURGEON HAD TO CONVERT TO A LAPAROTOMY AND THAT IS WHEN THE PIECE WAS FOUND IN THE PATIENT. THE PIECE WAS RETRIEVED. THE DOCTOR INDICATED THAT THE CONVERSION TO A LAPAROTOMY HAD TAKEN PLACE PRIOR TO THE ISSUE WITH THE TROCAR DUE TO DIFFICULTY WITH THE ANATOMY AND EXPOSURE ISSUES. THE TROCAR WAS A CONTRIBUTING FACTOR BUT NOT THE ONLY REASON THE LAPAROTOMY WAS PERFORMED. NO OTHER CHANGE IN POSTOP CARE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ENDOPATH XCEL BLADELESS TROCAR WITH STABILITY SLEEVE-12MM DIAMETER,100 MM LENGTH | GCJ | ETHICON ENDO-SURGERY, INC. (CINCINNATI) | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | YR | Required Intervention |