MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 1996-11-25 for HARMONIC SCAPEL LCS 15 NA manufactured by Ethicon Endo Surgery.
[31758]
Pt receiving lap assisted vaginal hysterectomy and physician using scalpel to cauterize bleeding vessels. Scapel did not coagulate requiring pt to have open laparotomy to control bleeding and to complete procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 52255 |
| MDR Report Key | 52255 |
| Date Received | 1996-11-25 |
| Date of Report | 1996-11-22 |
| Date of Event | 1996-11-13 |
| Date Facility Aware | 1996-11-13 |
| Report Date | 1996-11-22 |
| Date Reported to FDA | 1996-11-22 |
| Date Reported to Mfgr | 1996-11-22 |
| Date Added to Maude | 1996-12-02 |
| 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 | 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 | HARMONIC SCAPEL |
| Generic Name | DISPOSABLE SCISSORS |
| Product Code | HIM |
| Date Received | 1996-11-25 |
| Returned To Mfg | 1996-11-13 |
| Model Number | LCS 15 |
| Catalog Number | NA |
| Lot Number | LE 0802-9 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 52908 |
| Manufacturer | ETHICON ENDO SURGERY |
| Manufacturer Address | 4545 CREEK RD CINCINNATI OH 45242 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Hospitalization | 1996-11-25 |