VERSAPORT* RT 5MM SURGISPIKE* W/ 5MM SEAL Adverse Event — Malfunction (MDR 2647580-2008-00080)
VERSAPORT* RT 5MM SURGISPIKE* W/ 5MM SEAL Adverse Event — Malfunction (MDR 2647580-2008-00080) is one of 9,000 device adverse events in the DeviceEvents dataset. Key details — Device: VERSAPORT* RT 5MM SURGISPIKE* W/ 5MM SEAL; Generic name: DISPOSABLE SURGICAL ACCESS DEVICE; Manufacturer: PONCE - USS.
| Device | VERSAPORT* RT 5MM SURGISPIKE* W/ 5MM SEAL |
|---|---|
| Generic name | DISPOSABLE SURGICAL ACCESS DEVICE |
| Manufacturer | PONCE - USS |
| Report number | 2647580-2008-00080 |
| Event type | Malfunction |
| Product problem | Y |
| Date received | 2008-02-19 |
| Report source | Foreign, User facility |
| Narrative | PROCEDURE TYPE: CHOLECYSTECTOMY. ACCORDING TO THE REPORTER: THE SAFETY SHIELD WAS NOT PROTECTING THE OBTURATOR BLADE. THE BLADE HAD PENETRATED THE PACKAGING. THIS WAS FOUND BEFORE THE OPERATION. |
| Source | openFDA MAUDE (device adverse events) |
🔍 Search all device adverse events →
$1999/mo
Try DeviceEvents →