MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2018-06-10 for VARADY PHLEBECTOMY EXTRACTOR, 6-3/4 SM HOOK 10310 manufactured by Hebumedical Gmbh.
[110579140]
The device was returned without the broken-off tip. It had been manufactured in november 2017. Review of manufacturing records confirmed device conformance to specs at time of release. Hardness of returned device was tested and found conforming to specifications. The device was subject to microscopic examination. It showed no evidence of extensive reuse. Since the device was returned incomplete, i. E. , without the broken-off tip, it is not possible to reach a definite conclusion with regard to the cause of the fracture. However, this type of extractor has a very delicate hook tip and the tip may fracture if excessive pressure is applied by the surgeon.
Patient Sequence No: 1, Text Type: N, H10
[110579141]
During an unspecified procedure the hook of the varady phlebectomy extractor broke off. No patient contact, injury, or surgery delay was reported. Additional information was requested but no other clinical information has been provided.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611112-2018-00003 |
| MDR Report Key | 7585423 |
| Report Source | OTHER |
| Date Received | 2018-06-10 |
| Date of Report | 2018-06-10 |
| Date of Event | 2018-04-11 |
| Date Mfgr Received | 2018-05-16 |
| Device Manufacturer Date | 2017-11-02 |
| Date Added to Maude | 2018-06-10 |
| 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 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MR. THOMAS BUTSCH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer G1 | HEBUMEDICAL GMBH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal Code | 78532 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | VARADY PHLEBECTOMY EXTRACTOR, 6-3/4 SM HOOK |
| Generic Name | EXTRACTOR |
| Product Code | GAI |
| Date Received | 2018-06-10 |
| Returned To Mfg | 2018-05-22 |
| Catalog Number | 10310 |
| Lot Number | 100088-1711 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | HEBUMEDICAL GMBH |
| Manufacturer Address | BADSTRASSE 8 TUTTLINGEN, 78532 GM 78532 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2018-06-10 |