MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1996-12-30 for ENDOPATH SUBCU-RETRACTOR SVSR1 manufactured by Lacey Manufacturing Co..
[40248]
The svsd1 and svsr1 were used during a laparoscopic vein harvest. The scope would not insert properly into the subcu-dissector. It was blocked at the junction of the metal shaft and the plastic spoon. A similar problem was found with the subcu-rectractor. Devices from kit ftv01. The procedure was abandoned and the surgeon converted to an open procedure.
Patient Sequence No: 1, Text Type: D, B5
[18594004]
Device was not returned for analysis.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1218017-1996-00050 |
| MDR Report Key | 60126 |
| Report Source | 07 |
| Date Received | 1996-12-30 |
| Date of Report | 1996-12-30 |
| Date of Event | 1996-12-03 |
| Date Mfgr Received | 1996-12-03 |
| Date Added to Maude | 1997-01-07 |
| 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 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ENDOPATH SUBCU-RETRACTOR |
| Generic Name | SUBCU-RETRACTOR |
| Product Code | GCM |
| Date Received | 1996-12-30 |
| Model Number | NA |
| Catalog Number | SVSR1 |
| Lot Number | UNK |
| ID Number | BATCH # UNK |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | NA |
| Device Eval'ed by Mfgr | R |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 60536 |
| Manufacturer | LACEY MANUFACTURING CO. |
| Manufacturer Address | 1146 BARNUM AVENUE 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 | 1996-12-30 |