| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | LIGASURE ADVANCE PISTOL GRIP | LIGASURE VESSEL SEALING SYSTEM | COVIDIEN LP | BWA | LF5544 | LF5544 | 51490024X | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2015-11-24 | 0 |
Patient 1
(B)(4). DATE OF INITIAL REPORT : (B)(6) 2015. TO DATE THE INCIDENT SAMPLE HAS NOT BEEN RECEIVED FOR EVALUATION. IF THE SAMPLE IS RECEIVED OR IF ADDITIONAL INFORMATION PERTINENT TO THE INCIDENT IS OBTAINED A FOLLOW-UP REPORT WILL BE SUBMITTED.
Patient 1
THE CUSTOMER REPORTED THAT DURING A TOTAL LAPAROSCOPIC HYSTERECTOMY BLEEDING WAS OBSERVED AT THE BROAD, UTERINE AND OVARIAN LIGAMENTS WHERE THE DEVICE HAD BEEN USED. END TONES, INDICATING A COMPLETE SEAL CYCLE, WERE PROVIDED BY THE GENERATOR IN USE. A NEW DEVICE OF THE SAME TYPE WAS OPENED AND USED TO SUCCESSFULLY COMPLETE THE CASE. THERE WAS NO PATIENT INJURY.
Patient 1
(B)(4). ONE USED LF5544 WAS RECEIVED FOR EVALUATION. EXAMINATION OF THE RETURNED SAMPLE COULD NOT CONFIRM THE REPORTED ISSUE. THE DEVICE WAS TESTED AND MULTIPLE SEALS WERE MADE ON PORCINE TISSUE OF VARIOUS SIZES. ALL SEAL CYCLES WERE COMPLETED SATISFACTORILY AND END TONES HEARD INDICATING COMPLETED ACTIVATION CYCLES. THE INVESTIGATION FOUND THE DEVICE TO FUNCTION NORMALLY AND WITHIN SPECIFICATIONS. REVIEW OF THE DEVICE HISTORY RECORDS FOR THIS PRODUCT FOUND NO POTENTIALLY CONTRIBUTING ENTRIES. THERE ARE ENVIRONMENTAL FACTORS DURING USE THAT CAN AFFECT SEAL QUALITY, AND THE INSTRUCTIONS-FOR-USE INCLUDED WITH THIS PRODUCT LISTS TISSUE SEALING RECOMMENDATIONS AND CAUTIONS.