MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a other report with the FDA on 2017-06-15 for MUELLER PHLEB HK RGHT SZ2 5 IN PHLEBECTOMY HOOK X21433 manufactured by Hebumedical Gmbh.
[77622475]
The device was returned without the broken-off tip. Review of manufacturing records confirmed device conformance to specs at time of release. Hardness of returned device was tested and found conforming to specifications. 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 hook has a very delicate tip ranging from 0. 5mm to 1. 0mm in width due to the natural anatomical requirements of the vein-stripping procedure, and the tip may fracture if excessive pressure is applied by the surgeon. Thus the device most likely was not used in accordance with recognized best practices. A review of complaint history for this device for the last three years revealed no similar cases.
Patient Sequence No: 1, Text Type: N, H10
[77622476]
Customer reports device tip broke off during a vein ligation and stripping on left leg. Tip retrieved, no patient harm. Device #1 of 3 used during same procedure.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 9611112-2017-00002 |
| MDR Report Key | 6642645 |
| Report Source | OTHER |
| Date Received | 2017-06-15 |
| Date of Report | 2017-06-15 |
| Date of Event | 2017-04-07 |
| Date Mfgr Received | 2017-05-16 |
| Device Manufacturer Date | 2016-06-01 |
| Date Added to Maude | 2017-06-15 |
| 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 | MR. THOMAS BUTSCH |
| Manufacturer Street | BADSTRASSE 8 |
| Manufacturer City | TUTTLINGEN, 78532 |
| Manufacturer Country | GM |
| Manufacturer Postal | 78532 |
| Manufacturer Phone | 46194710 |
| 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 | MUELLER PHLEB HK RGHT SZ2 5 IN PHLEBECTOMY HOOK |
| Generic Name | PHLEBECTOMY HOOK |
| Product Code | GAI |
| Date Received | 2017-06-15 |
| Returned To Mfg | 2017-05-23 |
| Catalog Number | X21433 |
| Lot Number | 31018529 |
| 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 | 1. Required No Informationntervention | 2017-06-15 |