MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1994-01-09 for ELECTROSURGICAL GENERATOR (E.S.U.) SSE2L N/A manufactured by Valleylab, Inc..
[3591]
During ercp spkinectomey, dr. Had cautery settings on coag #3 and cut #3. After several attempts at trying to cut the pancreatic and comon bile duct. Dr. Order increase cut level to #4. After several attempts per dr. , on the 4th attempt stated "it cut too much" abdominal x-ray taken. Patient to ccu. Exploratory surgery later that evening. Device not labeled for single use. Patient medical status prior to event: satisfactory condition. There was not multiple patient involvement. Device serviced in accordance with service schedule. Date last serviced: 01-apr-93. Service provided by: user facility biomedical/bioengineering department. Service records available. No imminent hazard to public health claimed. Device used as labeled/intended. Invalid data - regarding evaluation by user after event. Method of evaluation: none or unknown. Results of evaluation: none or unknown. Conclusion: none or unknown. Certainty of device as cause of or contributor to event: invalid data. Corrective actions: device temporarily removed from service. Invalid data - on device destroyed/disposed of status.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 7499 |
| MDR Report Key | 7499 |
| Date Received | 1994-01-09 |
| Date of Report | 1993-09-21 |
| Date of Event | 1993-08-24 |
| Date Facility Aware | 1993-08-30 |
| Report Date | 1993-09-21 |
| Date Reported to Mfgr | 1993-08-30 |
| Date Added to Maude | 1994-04-26 |
| 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 |
| Health Professional | 0 |
| Initial Report to FDA | 0 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELECTROSURGICAL GENERATOR (E.S.U.) |
| Generic Name | N/A |
| Product Code | FEH |
| Date Received | 1994-01-09 |
| Model Number | SSE2L |
| Catalog Number | N/A |
| Lot Number | N/A |
| ID Number | BIO-MED CONTROL #00186 |
| Device Availability | Y |
| Device Age | 01-DEC-82 |
| Implant Flag | N |
| Device Sequence No | 1 |
| Device Event Key | 7178 |
| Manufacturer | VALLEYLAB, INC. |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 1994-01-09 |