MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1995-02-13 for VALLEYLAB ESU FORCE 4B manufactured by Valleylab.
[15485669]
Patient had radioactive seeds in prostate, implanted 14 days before surgery. During transurethral resection of prostate procedure, muscle twitching, and spasms occurred each time electro-surgical unit was used. General anesthetic with muscle paralysis had to be done in order to proceed with the surgery.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 19700 |
| MDR Report Key | 19700 |
| Date Received | 1995-02-13 |
| Date of Report | 1994-08-18 |
| Date of Event | 1994-08-15 |
| Date Facility Aware | 1994-08-15 |
| Report Date | 1994-08-19 |
| Date Reported to Mfgr | 1994-08-26 |
| Date Added to Maude | 1995-02-14 |
| 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 | VALLEYLAB ESU |
| Generic Name | ELECTROSURGICAL UNIT |
| Product Code | FAR |
| Date Received | 1995-02-13 |
| Model Number | FORCE 4B |
| ID Number | SETTINGS-COAG 75 CUT 205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 5 YR |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 19604 |
| Manufacturer | VALLEYLAB |
| Manufacturer Address | 5920 LONG BOW DR. P.O. BOX 9015 BOULDER CO 80301 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1995-02-13 |