MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2013-12-24 for WECK HEM-O-LOK * 544240 manufactured by Telefex Medical.
[4190867]
Endowrist clip appliers with weck hem-o-lok clips was being used when the clips would close but not lock. Multiple attempts were made with different clips from different packs. A total of 5 packs and different appliers were used to rule out calibration issues. No blood loss was noted and no incision was made until the clips worked appropriately.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 3588765 |
| MDR Report Key | 3588765 |
| Date Received | 2013-12-24 |
| Date of Report | 2013-12-24 |
| Date of Event | 2013-08-15 |
| Report Date | 2013-12-24 |
| Date Added to Maude | 2014-01-23 |
| Event Key | 0 |
| Report Source Code | User Facility report |
| Manufacturer Link | N |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | RISK MANAGER |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 0 |
| Previous Use Code | 0 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | WECK HEM-O-LOK |
| Generic Name | LIGATING CLIP |
| Product Code | HBQ |
| Date Received | 2013-12-24 |
| Returned To Mfg | 2013-08-16 |
| Model Number | * |
| Catalog Number | 544240 |
| Lot Number | 01B1300444 |
| ID Number | * |
| Operator | PHYSICIAN |
| Device Availability | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFEX MEDICAL |
| Manufacturer Address | P O BOX 12600 DURHAM NC 27709 US 27709 |
| Brand Name | ENDOWRIST |
| Generic Name | SYSTEM, SURGICAL, COMPUTER CONTROLLED INSTRUMENT |
| Product Code | NAY |
| Date Received | 2013-12-24 |
| Model Number | * |
| Catalog Number | 420230 |
| Lot Number | * |
| ID Number | * |
| Device Availability | R |
| Device Age | * |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TELEFEX MEDICAL |
| Manufacturer Address | P O BOX 12600 DURHAM CA 27709 US 27709 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-12-24 |