MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-08-03 for GS2000 INSUFFLATOR 50L INSUFFLATOR manufactured by Conmed Corporation.
[51468515]
The pneumoperitoneum was then hooked up through the port. In the usual fashion we attempted to insufflate the abdomen to 15 mmhg, which the settings were confirmed on insufflation machine. Her abdomen became distended and we noticed after a few seconds that it was over distended and that we were having difficulty ventilating the pt all of a sudden. The abdomen was very rigid. After a few seconds, we evacuated the pneumoperitoneum. The insufflation was stopped. At this point we realized that the insufflator had malfunctioned and the pt had received a greater than desired amount of co2 to the abdomen and there had been extravasation of the co2 into her tissue planes on her chest wall, up into her scalp, face causing crepitus throughout. (b)(4).
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5063880 |
| MDR Report Key | 5852998 |
| Date Received | 2016-08-03 |
| Date of Report | 2016-08-03 |
| Date of Event | 2016-07-29 |
| Date Added to Maude | 2016-08-08 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | GS2000 INSUFFLATOR |
| Generic Name | GS2000 INSUFFLATOR |
| Product Code | FCX |
| Date Received | 2016-08-03 |
| Model Number | 50L INSUFFLATOR |
| Catalog Number | GS2000 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | CONMED CORPORATION |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2016-08-03 |