FDA Adverse Event
Other
Summary report: N
GELPOINT SYSTEM, 100MM
MDR report key: 1604271
·
Received February 5, 2010
Report
- Report Number
- 2027111-2010-00014
- Event Type
- Other
- Date Received
- February 5, 2010
- Date of Event
- January 25, 2010
- Report Date
- February 4, 2010
- Manufacturer
- APPLIED MEDICAL RESOURCES
- Product Code
- GCJ
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
PRODUCT IS ANTICIPATED TO RETURN FOR EVAL. FOLLOW-UP WILL BE PROVIDED UNTIL CLOSURE.
Description of Event or Problem · 1
"PROCEDURE: LAPAROSCOPIC CHOLECYSTECTOMY - USING A 5MM KARL STORZ TELESCOPE, THE TROCAR CAME OUT OF THE GEL CAP. IN SO DOING, THE GEL WAS DAMAGED AND FRAGMENTS FELL INTO THE ABDOMINAL CAVITY. THESE WERE REMOVED. ONE PIECE OF GEL WAS TRAPPED BETWEEN THE ALEXIS SHEATH AND THE ABDOMEN. THIS WAS LATER REMOVED. ON INSPECTION, AT THE END OF THE CASE, THE INNER SURFACE OF THE GEL SHOWED FURTHER DAMAGE. THIS DID NOT INFLUENCE THE OUTCOME OF THE OPERATION. THE SURGEON FELT THIS SHOULD BE DRAWN TO THE ATTENTION OF APPLIED. HIS QUESTION RELATES TO THE COMPOSITION OF THE GEL AND ITS DURABILITY."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GELPOINT SYSTEM, 100MM | NONE | GCJ | APPLIED MEDICAL RESOURCES | CNGL2 | 1102319 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |