MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a foreign report with the FDA on 2015-12-16 for SYMMETRY VEIN STRIPPER 63-4031 manufactured by Symmetry Surgical Inc..
[34934919]
Surgeon: mr. (b)(6) (regular user of product) performed a varicose vein procedure on one leg of patient with success, and then used the same line and a new olive for the second leg of the same patient. Product specialist cannot confirm if tension of the line or loading was checked by the surgeon or medical staff before performing the second leg. The surgeon inserted the line on the second leg but on removal, the olive tip and the vein remained in the situ. Retrieval was not performed on the date of incident. The surgeon was not prepared to do so as the patient was large and has large dermatitis legs. Patient was stable and discharged from hospital on (b)(6) 2015. Retrieval surgery booked for (b)(6) 2015.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3007208013-2015-00038 |
| MDR Report Key | 5332380 |
| Report Source | FOREIGN |
| Date Received | 2015-12-16 |
| Date of Report | 2015-12-16 |
| Date of Event | 2015-11-13 |
| Date Facility Aware | 2015-11-13 |
| Date Mfgr Received | 2015-11-26 |
| Device Manufacturer Date | 2015-01-26 |
| Date Added to Maude | 2015-12-29 |
| 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 | MS. VICTORIA ROGERS |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal | 37013 |
| Manufacturer Phone | 8002513000 |
| Manufacturer G1 | SYMMETRY SURGICAL INC. |
| Manufacturer Street | 3034 OWEN DR |
| Manufacturer City | ANTIOCH TN 37013 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 37013 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | SYMMETRY VEIN STRIPPER |
| Generic Name | DISPOSABLE VEIN STRIPPER |
| Product Code | GAJ |
| Date Received | 2015-12-16 |
| Model Number | 63-4031 |
| Catalog Number | 63-4031 |
| Lot Number | 205107 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | 1 YR |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | SYMMETRY SURGICAL INC. |
| Manufacturer Address | 3034 OWEN DR ANTIOCH TN 37013 US 37013 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2015-12-16 |