MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 08 report with the FDA on 2002-10-18 for ALLEGIANCE POOLE SUCTION INSTRUMENT * K770 manufactured by Busse Hospital Disposbles.
[251747]
Physician phoned distributor and stated that he was using the poole suction handle during an orthopedic surgery and he used the handle to push on a structure in the shoulder and the handle broke. A piece broke off. Physician not certain where the piece is. Ct scan was done and the piece could not be found. Physician admitted to user error. He just wanted to know if it was in the patient could he leave it with no patient risk.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2433012-2002-00001 |
| MDR Report Key | 423752 |
| Report Source | 08 |
| Date Received | 2002-10-18 |
| Date of Report | 2002-10-17 |
| Date of Event | 2002-09-01 |
| Date Mfgr Received | 2002-09-19 |
| Date Added to Maude | 2002-10-25 |
| 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 | VICKI ATOR |
| Manufacturer Street | 75 ARKAY DRIVE |
| Manufacturer City | HAUPPAUGE NY 11788 |
| Manufacturer Country | US |
| Manufacturer Postal | 11788 |
| Manufacturer Phone | 6314354711 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ALLEGIANCE POOLE SUCTION INSTRUMENT |
| Generic Name | POOLE SUCTION INSTRUMENT |
| Product Code | EBR |
| Date Received | 2002-10-18 |
| Model Number | * |
| Catalog Number | K770 |
| Lot Number | UNK |
| ID Number | * |
| 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 | 412805 |
| Manufacturer | BUSSE HOSPITAL DISPOSBLES |
| Manufacturer Address | 75 ARKAY DR. HAUPPAUGE NY 11788 US |
| Baseline Brand Name | ALLEGIANCE |
| Baseline Generic Name | POOLE SUCTION INSTRUMENT |
| Baseline Model No | NA |
| Baseline Catalog No | K770 |
| Baseline ID | NA |
| Baseline Device Family | POOLE SUCTION INSTRUMENT |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | N |
| Baseline Preamendment | Y |
| Baseline Transitional | N |
| 510k Exempt | Y |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2002-10-18 |