MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2005-09-09 for BAUMGARTEN WIRE TWISTER 142521 manufactured by Pilling Surgical.
[394365]
During the suturing process of an open heart surgery, a small piece of carbide insert broke on each side of the wire twister. One piece was located on the surgery table. The other piece was not found. An x-ray was performed and there were no foreign objects in the patient. The surgery was completed with no adverse event or injury to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2515651-2005-00006 |
| MDR Report Key | 670250 |
| Report Source | 05 |
| Date Received | 2005-09-09 |
| Date of Report | 2005-09-09 |
| Date of Event | 2005-08-05 |
| Date Mfgr Received | 2005-08-08 |
| Date Added to Maude | 2006-02-03 |
| 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 | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | DAN DAILY, RCP, RRT, MRG |
| Manufacturer Street | 2917 WECK DRIVE |
| Manufacturer City | RTP NC 27709 |
| Manufacturer Country | US |
| Manufacturer Postal | 27709 |
| Manufacturer Phone | 9193614029 |
| Manufacturer G1 | * |
| Manufacturer Street | * |
| Manufacturer City | * |
| Manufacturer Country | * |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | BAUMGARTEN WIRE TWISTER |
| Generic Name | WIRE TWISTER FORCEP |
| Product Code | HXS |
| Date Received | 2005-09-09 |
| Returned To Mfg | 2005-08-15 |
| Model Number | NA |
| Catalog Number | 142521 |
| Lot Number | VV4 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | NA |
| Device Eval'ed by Mfgr | N |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 659564 |
| Manufacturer | PILLING SURGICAL |
| Manufacturer Address | * HORSHAM PA * US |
| Baseline Brand Name | BAUMGARTEN WIRE TWISTER |
| Baseline Generic Name | WIRE TWISTER FORCEP |
| Baseline Model No | NA |
| Baseline Catalog No | 142521 |
| Baseline ID | NA |
| Baseline Device Family | WIRE TWISTER |
| 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 | 2005-09-09 |