MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-02-28 for HALO PKS 5MM/33CM HACF0533 manufactured by Gyrus Acmi, Inc.
[3128468]
Surgeon reported that cutting forceps were dull. What was the original intended procedure? Total laparoscopic hystectomy.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2992222 |
| MDR Report Key | 2992222 |
| Date Received | 2013-02-28 |
| Date of Report | 2013-02-28 |
| Date of Event | 2013-02-26 |
| Report Date | 2013-02-28 |
| Date Reported to FDA | 2013-02-28 |
| Date Reported to Mfgr | 2013-03-07 |
| Date Added to Maude | 2013-03-07 |
| 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 |
| 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 | HALO PKS |
| Generic Name | ELECTROSURGICAL, CUTTING & COAGULATION |
| Product Code | HIN |
| Date Received | 2013-02-28 |
| Model Number | 5MM/33CM |
| Catalog Number | HACF0533 |
| Lot Number | JF514277 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | Y |
| Device Age | 0 DY |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | GYRUS ACMI, INC |
| Manufacturer Address | 136 TURNPIKE ROAD SOUTHBOROUGH MA 01772 US 01772 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-02-28 |