MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2006-06-01 for ROTO-CAM MINI SCISSORS, MONOPOLAR, 5MM * 625-240 manufactured by Gs-verpackungsfolie.
[19154339]
Due to a broken hinge, the scissors would not close. As a result, they would not fit through the trocar to be removed from the pt's abdomen. Another instrument was used to manipulate the scissors into the trocar.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2430952-2006-00026 |
| MDR Report Key | 722629 |
| Date Received | 2006-06-01 |
| Date of Report | 2006-06-01 |
| Date Facility Aware | 2006-04-17 |
| Report Date | 2006-06-01 |
| Date Added to Maude | 2006-06-07 |
| Event Key | 0 |
| Report Source Code | Distributor report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| 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 | ROTO-CAM MINI SCISSORS, MONOPOLAR, 5MM |
| Generic Name | JARIT ENDOSCOPIC INST. |
| Product Code | HRR |
| Date Received | 2006-06-01 |
| Returned To Mfg | 2006-05-09 |
| Model Number | * |
| Catalog Number | 625-240 |
| Lot Number | * |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | * |
| Implant Flag | N |
| Date Removed | * |
| Device Sequence No | 1 |
| Device Event Key | 711699 |
| Manufacturer | GS-VERPACKUNGSFOLIE |
| Manufacturer Address | * WUMLINGEN GM |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2006-06-01 |