MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 07 report with the FDA on 1997-03-07 for ENDOPATH VESSEL DISSECTOR SVVD1 manufactured by Lacey Manufacturing Co..
[15591429]
H6; code 100: received with broken c-tip, fractural proximal to gusset. Analysis conclusion: based upon the inquiry info received and the visual examination, it was concluded that the c-hook tip had broken from the shaft during surgery, making the instrument non functional. The dissector was received with the c-tip fractured off just proximal to the gusset and it was returned in a separate bag. The dissector would not function as designed due to a broken c-hook tip and no conclusion could be reached as to how this damage had occurred. Each instrument is evaluated during the assembly process to ensure that it functions properly. The dissector's c-hook may become compromised if excessive force of torquing is applied to the tip.
Patient Sequence No: 1, Text Type: N, H10
[21701981]
During an endoscopic vessel harvesting for a coronary artery bypass graft the "c" shaped tip of the vessel dissector broke off in the patient as the surgeon used the device for dissection from the knee to the groin. An incision was made to remove the broken piece of the instrument. The svvd1 was from the ftv04 kit. 2/17/1997 1525 made courtesy call to risk management, she stated she would try to obtain additional information for the cin. She also requested the cin contact biomedical engineering. The cin left pm. 2/18/1997 1845 safety officer returned the telephone call and stated he would fax information to the cin. 2/21/1997 1130 sales rep stated she spoke with one of the surgeons in the case and the incision made to retrieve the piece of the instrument was one which was going to be made anyway to complete the case. It was not an incision made solely to retrieve the piece.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1218017-1997-00022 |
| MDR Report Key | 86519 |
| Report Source | 07 |
| Date Received | 1997-03-07 |
| Date of Report | 1997-03-07 |
| Date of Event | 1997-02-07 |
| Date Mfgr Received | 1997-02-08 |
| Device Manufacturer Date | 1996-09-01 |
| Date Added to Maude | 1997-04-28 |
| 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 VESSEL DISSECTOR |
| Generic Name | VESSEL DISSECTOR |
| Product Code | GCM |
| Date Received | 1997-03-07 |
| Model Number | NA |
| Catalog Number | SVVD1 |
| Lot Number | NI |
| ID Number | BATCH# JK3250 |
| Device Expiration Date | 2001-08-01 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | NA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | A |
| Device Sequence No | 1 |
| Device Event Key | 85707 |
| Manufacturer | LACEY MANUFACTURING CO. |
| Manufacturer Address | 1146 BARNUM AVE. BRIDGEPORT CT 06610 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 | 1997-03-07 |