MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2001-11-14 for 5MM X 32CM, A-TRAC LAPAROSCOPIC GRASPER C5208 100646801 manufactured by Applied Medical Resources.
[237295]
The jaws of the grasper out of alignment and as a result the doctor damaged a fallopian tube. Cautery on the fallopian tube was used as medical intervention. In following up, there was no permanent injury or patient complications.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2027111-2001-00035 |
| MDR Report Key | 360237 |
| Report Source | 08 |
| Date Received | 2001-11-14 |
| Date of Report | 2001-11-13 |
| Date Mfgr Received | 2001-09-04 |
| Device Manufacturer Date | 2000-01-01 |
| Date Added to Maude | 2001-11-19 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| 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 |
| Manufacturer Contact | KAREN VANDENBROEK |
| Manufacturer Street | 22872 AVENIDA EMPRESA |
| Manufacturer City | RANCHO SANTA MARGARITA CA 92688 |
| Manufacturer Country | US |
| Manufacturer Postal | 92688 |
| Manufacturer Phone | 9497138000 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | 5MM X 32CM, A-TRAC LAPAROSCOPIC GRASPER |
| Generic Name | A-TRAC GRASPER |
| Product Code | GCF |
| Date Received | 2001-11-14 |
| Returned To Mfg | 2001-09-04 |
| Model Number | C5208 |
| Catalog Number | 100646801 |
| Lot Number | EOM028 |
| ID Number | * |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | U |
| Device Sequence No | 1 |
| Device Event Key | 349405 |
| Manufacturer | APPLIED MEDICAL RESOURCES |
| Manufacturer Address | 22872 AVENIDA EMPRESA RANCHO SANTA MARGARITA CA 92688 US |
| Baseline Brand Name | 5MM X 32CM, A-TRAC LAPAROSCOPIC GRASPER |
| Baseline Generic Name | GRASPER |
| Baseline Model No | C5208 |
| Baseline Catalog No | 100646801 |
| Baseline ID | NA |
| Baseline Device Family | A-TRAC CLAMPING SYSTEMS |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2001-11-14 |