MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,05,06 report with the FDA on 2004-04-21 for SCANLAN INTERNATIONAL, INC. 7007-222-1SC manufactured by Scanlan Intl., Inc..
[364664]
Scissors blade fragment became detatched during mitral valve procedure and remains in pt. Additional surgical intervention including reopening the chest incision to retrieve the fragment was not successful.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2126670-2004-00001 |
| MDR Report Key | 522090 |
| Report Source | 01,05,06 |
| Date Received | 2004-04-21 |
| Date of Report | 2004-04-22 |
| Date of Event | 2004-03-09 |
| Date Mfgr Received | 2004-03-22 |
| Device Manufacturer Date | 2000-03-01 |
| Date Added to Maude | 2004-04-27 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 0 |
| Manufacturer Contact | KENNETH BLAKE |
| Manufacturer Street | ONE SCANLAN PLAZA |
| Manufacturer City | ST. PAUL MN 55107 |
| Manufacturer Country | US |
| Manufacturer Postal | 55107 |
| Manufacturer Phone | 6512980997 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | SCANLAN INTERNATIONAL, INC. |
| Generic Name | SURGICAL SCISSORS |
| Product Code | JOK |
| Date Received | 2004-04-21 |
| Model Number | 7007-222-1SC |
| Catalog Number | 7007-222-1SC |
| Lot Number | R91 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 511220 |
| Manufacturer | SCANLAN INTL., INC. |
| Manufacturer Address | * ST PAUL MN * US |
| Baseline Brand Name | SCANLAN |
| Baseline Generic Name | SURGICAL SCISSORS |
| Baseline Model No | 7007-222-1SC |
| Baseline Catalog No | 7007-222-1SC |
| Baseline ID | LOT #R91 |
| Baseline Device Family | SCISSORS AND MICRO-SCISSORS |
| 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 | 2004-04-21 |