MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-03-02 for WECK HEM-O-LOCK manufactured by Teleflex.
[69252702]
Patient having laparoscopic cholecystectomy. During procedure, it was noted that the disposable weck hem-o-lock device had malfunctioned. Surgeon found the tip to be loose and it broke off in his hand. Second hem-o-lock was opened and found to be defective also - the clip would not open fully when it was engaged in the instrument. No harm to the patient.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5068274 |
| MDR Report Key | 6380648 |
| Date Received | 2017-03-02 |
| Date of Report | 2017-03-02 |
| Date of Event | 2017-02-24 |
| Date Added to Maude | 2017-03-06 |
| Event Key | 0 |
| Report Source Code | Voluntary 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 | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | WECK HEM-O-LOCK |
| Generic Name | WECK HEM-O-LOCK |
| Product Code | HBQ |
| Date Received | 2017-03-02 |
| Lot Number | 73A1700205 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | MORRISVILLE NC 27560 US 27560 |
| Brand Name | WECK HEM-O-LOCK |
| Generic Name | WECK HEM-O-LOCK |
| Product Code | HBQ |
| Date Received | 2017-03-02 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 2 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX |
| Manufacturer Address | MORRISVILLE NC 27560 US 27560 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2017-03-02 |