MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-06-04 for SUN MEDICAL SMOKE EVACUATOR SE-100 manufactured by Sun Medical, Inc..
[25693]
During a lap cholecystectomy, ventilating pressures rapidly increased to 60-70 when smoke evacuator was turned on. Abdominal pressure went into 20's. When evacuator turned off, pressures returned to normal. Evacuator turned on x2, with same results. Evacuator not used for remainder of case. "tandem" cap on smoke evacuator found uncapped at the end of the case. No alarm on medical device. Pneumothorax was identified on chest x-ray, 14g cath placed to aspirate pneumothorax.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 33641 |
| MDR Report Key | 33641 |
| Date Received | 1996-06-04 |
| Date of Report | 1996-06-04 |
| Date of Event | 1996-06-03 |
| Date Facility Aware | 1996-06-03 |
| Report Date | 1996-06-04 |
| Date Reported to FDA | 1996-06-04 |
| Date Reported to Mfgr | 1996-06-04 |
| Date Added to Maude | 1996-06-27 |
| 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 | 0 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SUN MEDICAL SMOKE EVACUATOR |
| Generic Name | SMOKE EVACUATOR |
| Product Code | FCZ |
| Date Received | 1996-06-04 |
| Model Number | SE-100 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 34992 |
| Manufacturer | SUN MEDICAL, INC. |
| Manufacturer Address | 1179 CORPORATE DR W, STE 100 ARLINGTON TX 76006 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization; 2. Required No Informationntervention | 1996-06-04 |