MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2016-01-04 for INSUFFLATOR, AUTOMATIC CARBONDIOXIDE FOR ENDSCOPE manufactured by Stryker.
[34906472]
Patient Sequence No: 1, Text Type: N, H10
[34906473]
While the surgical case was in progress, the insufflation device stopped working. Surgeon lost air at a critical point during surgery while bleeding was occuring. Insufflation box showed 1/4 bar of co2 still remaining. Immediate troubleshooting action occurred including checking ports in patient for leak, switching co2 over to spare tank on tower, which did nothing and turning device off and back on. Equipment technician notified to come into room stat with additional co2 tank. He then switched tanks and it was noted that both of the original tanks still had co2 remaining. He also check all connections and turned machine off and back on. Machine still remained broken and showed 1/4 bar of co2 remaining. A few minutes went by and machine suddenly started working again. Dr. Involved with entire processes. No injury to patient. Clinical engineering checked and no problem found. Clinical engineering unable to duplicate event.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 5340082 |
| MDR Report Key | 5340082 |
| Date Received | 2016-01-04 |
| Date of Report | 2015-12-04 |
| Date of Event | 2015-12-01 |
| Report Date | 2015-12-04 |
| Date Reported to FDA | 2015-12-04 |
| Date Reported to Mfgr | 2015-12-04 |
| Date Added to Maude | 2016-01-04 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | 3 |
| Generic Name | INSUFFLATOR, AUTOMATIC CARBONDIOXIDE FOR ENDSCOPE |
| Product Code | FCX |
| Date Received | 2016-01-04 |
| ID Number | 13988021 |
| Device Availability | Y |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | STRYKER |
| Manufacturer Address | 5900 OPTICAL COURT SAN JOSE CA 95138 US 95138 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2016-01-04 |