MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-09-04 for ENDOPATH VESSEL DISSECTOR SVVD1 manufactured by Lacey Manufacturing Co..
[75659]
The device was used during a saphenous vein harvesting. The tip of the vessel dissector broke off. There was much force on the dissector as it was being pushed in front of the retractopr. The surgeon elected to make a small separate incision retrieve the tip to complete the case.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218017-1996-00003 |
| MDR Report Key | 133375 |
| Report Source | 07 |
| Date Received | 1996-09-04 |
| Date of Report | 1996-08-16 |
| Date of Event | 1996-08-12 |
| Date Mfgr Received | 1996-08-12 |
| Date Added to Maude | 1997-11-21 |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH VESSEL DISSECTOR |
| Generic Name | VESSEL DISSECTOR |
| Product Code | GCM |
| Date Received | 1996-09-04 |
| Model Number | NA |
| Catalog Number | SVVD1 |
| Lot Number | UNK |
| ID Number | BATCH # UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NO INFO |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 130353 |
| Manufacturer | LACEY MANUFACTURING CO. |
| Manufacturer Address | 1146 BARNUM AVE. BRIDGEPORT CT 066100156 US |
| Baseline Brand Name | ENDOPATH VESSEL DISSECTOR |
| Baseline Generic Name | VESSEL DISSECTOR |
| Baseline Model No | NA |
| Baseline Catalog No | SVVD1 |
| Baseline ID | NA |
| Baseline Device Family | ENDOSCOPIC VEIN HARVESTING DEVICES |
| Baseline Shelf Life [Months] | NA |
| Baseline PMA Flag | N |
| Baseline 510K PMN | Y |
| Premarket Notification | K955120 |
| Baseline Preamendment | N |
| Baseline Transitional | N |
| 510k Exempt | N |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 1996-09-04 |