MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,07 report with the FDA on 2000-04-28 for AMSCO 1080 MANUAL SURGICAL TABLE NA manufactured by Steris Corp..
[19966257]
The hosp reported that during a surgical procedure using a 45 year old table, the pt sustained a severed fingertip when hand became caught between the table siderail and the i. A. Board support/attachment clip. According to the hosp, the fingertip was reattached and postoperatively the pt is recovering.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1043572-2000-00002 |
| MDR Report Key | 275906 |
| Report Source | 05,07 |
| Date Received | 2000-04-28 |
| Date of Report | 2000-03-30 |
| Date of Event | 2000-03-22 |
| Date Mfgr Received | 2000-03-30 |
| Date Added to Maude | 2000-05-03 |
| 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 | 0 |
| Manufacturer Contact | ROBERT MCCALL |
| Manufacturer Street | 2720 GUNTER PARK DR E |
| Manufacturer City | MONTGOMERY AL 36109 |
| Manufacturer Country | US |
| Manufacturer Postal | 36109 |
| Manufacturer Phone | 3342133150 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | AMSCO 1080 MANUAL SURGICAL TABLE |
| Generic Name | SURGICAL TABLE |
| Product Code | FSE |
| Date Received | 2000-04-28 |
| Model Number | 1080 M |
| Catalog Number | NA |
| Lot Number | NA |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 267053 |
| Manufacturer | STERIS CORP. |
| Manufacturer Address | 2720 GUNTER PARK DRIVE EAST MONTGOMERY AL 36109 US |
| Baseline Brand Name | AMSCO 1080 SURGICAL TABLE |
| Baseline Generic Name | SURGICAL TABLE |
| Baseline Model No | 1080 M |
| Baseline Catalog No | 1080 M |
| Baseline ID | NA |
| Baseline Device Family | AMSCO 1080 SURGICAL TABLE |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2000-04-28 |