MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-11-20 for ENDOPATH SUBCU-RETRACTOR SVSR1 manufactured by Lacey Manufacturing Co..
[28844]
The pt underwent a coronary artery bypass graft on approx 10/21/96. The pt is a 67 yo obese female with history of diabetes. There was difficulty identifying the saphenous vein at the knee and the surgeon then used an ankle approach. The case was completed successfully and pt was discharged. One-two days port-op the pt developed infection in the leg. Was seen by surgeon on tuesday, 10/29/96. Today (10/31/96) pt is undergoing exploration of leg due to large amount of pus at the incision site. Surgeon stated at this time this is no fault of any instruments used during the case. Physician assistant performed the vein harvest. Pmh: chronic leg pain.
Patient Sequence No: 1, Text Type: D, B5
[7763796]
Unavailable device was not returned for eval.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218017-1996-00027 |
| MDR Report Key | 51496 |
| Report Source | 07 |
| Date Received | 1996-11-20 |
| Date of Report | 1996-11-20 |
| Date of Event | 1996-10-21 |
| Date Mfgr Received | 1996-10-22 |
| Date Added to Maude | 1996-11-27 |
| 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 | 0 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH SUBCU-RETRACTOR |
| Generic Name | SUBCU-RETRACTOR |
| Product Code | GCM |
| Date Received | 1996-11-20 |
| Model Number | NA |
| Catalog Number | SVSR1 |
| Lot Number | UNK |
| ID Number | BATCH# UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | UNKNOWN |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 52166 |
| Manufacturer | LACEY MANUFACTURING CO. |
| Manufacturer Address | 1146 BAMUM AVE BRIDGEPORT CT 06610 US |
| Baseline Brand Name | SUBCU-RETRACTOR |
| Baseline Generic Name | VESSEL DISSECTOR |
| Baseline Model No | NA |
| Baseline Catalog No | SVSR1 |
| Baseline ID | * |
| 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 | 1996-11-20 |