MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,08 report with the FDA on 2009-06-12 for HEMOLOK CLIPS ML 544230 manufactured by Teleflex Medical.
[1212485]
The event description was reported as: during a laparoscopic partial nephrectomy, the first clip fired and did not close properly. The clip was removed and discarded. There were subsequent problems with the following three clips. This is the first of four reports about the incidents with the clips from that same package. No patient injury reported.
Patient Sequence No: 1, Text Type: D, B5
[8408211]
Sample is not available for investigation. The results of this investigation are not available at the time of this report. A follow up report will be sent when investigation is complete.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 3003898360-2009-00101 |
| MDR Report Key | 1455302 |
| Report Source | 01,08 |
| Date Received | 2009-06-12 |
| Date of Report | 2009-06-03 |
| Date Mfgr Received | 2009-06-03 |
| Date Added to Maude | 2009-10-06 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | ANGELA BROWN, MGR |
| Manufacturer Street | 4024 STIRRUP CREEK DR. |
| Manufacturer City | DURHAM NC 27703 |
| Manufacturer Country | US |
| Manufacturer Postal | 27703 |
| Manufacturer Phone | 9194334901 |
| Manufacturer G1 | TELEFLEX MEDICAL |
| Manufacturer Street | PROLONGACION EUSEBIO KINO#1316,RANCHO EL DESCANSO |
| Manufacturer City | TECATE, B.C. C.P.214 |
| Manufacturer Country | MX |
| Manufacturer Postal Code | C.P. 2147 |
| Single Use | 3 |
| Remedial Action | OT |
| Previous Use Code | 3 |
| Removal Correction Number | NA |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | HEMOLOK CLIPS ML |
| Generic Name | LIGATION CLIPS |
| Product Code | FAP |
| Date Received | 2009-06-12 |
| Model Number | NA |
| Catalog Number | 544230 |
| Lot Number | T1264221 |
| ID Number | NA |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | TELEFLEX MEDICAL |
| Manufacturer Address | TECATE MX |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2009-06-12 |