| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | PNEUMOPERITONEUM INSUFFLATION NEEDLE | PNEUMOPERITONEUM INSUFFLATION NEEDLE | ETHICON ENDO-SURGERY, LLC. | FDP | NA | PN120 | NI | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2012-03-19 | 0 | 1. R |
Patient 1
IT WAS REPORTED THAT DURING THE PROCEDURE, AIR ENTERED INTO THE THORACIC CAVITY FROM THE T SHAPE STOPCOCK WHEN THE DEVICE WAS USED FOR DRAINAGE OF PLEURAL EFFUSION. AS A RESULT, THE PATIENT'S HOSPITALIZATION WAS EXTENDED BY ONE DAY. THE AIR IS STILL INSIDE THE THORACIC CAVITY.
Patient 1
(B)(4). INFORMATION ANTICIPATED, BUT UNAVAILABLE AT THIS TIME. THE EVENT WAS REVIEWED WITH AN EES CROSS-FUNCTIONAL TEAM CONSISTING OF CQ, MARKETING, RISK MANAGEMENT, MEDICAL AFFAIRS, AND ENGINEERING. ADDITIONAL QUESTIONS AND CLARIFICATION WERE REQUESTED AND THE FOLLOWING WAS PROVIDED BY THE AFFILIATE: THE INTENT OF THIS PRODUCT IS TO ESTABLISH PNEUMOPERITONEUM. WAS THE DEVICE BEING USED OFF LABEL? ---THE DOCTOR SAID THAT THE PNEUMO- MEANS LUNG. THEREFORE THE DOCTOR USED THE DEVICE FOR DRAINAGE OF PLEURAL EFFUSION. FOR YOUR INFORMATION, OUR SALES REP TOLD THE DOCTOR THAT THE INTENT OF THE DEVICE IS TO ESTABLISH PNEUMOPERITONEUM. IS IT COMMON PRACTICE WITH THIS SURGEON AND/OR ACCOUNT TO USE A PN120 FOR DRAINAGE OF PLEURAL EFFUSION?---YES. WHAT DEVICES ARE TYPICALLY USED FOR DRAINING PLEURAL EFFUSIONS?---THE DEVICE WAS USED FOR DRAINAGE OVER 10 YEARS. WHAT WAS THE INTENT OF THE USE OF THIS DEVICE DURING THIS PROCEDURE? ---FOR DRAINAGE. THE STOPCOCK WAS CONNECTED TO TUBE AND SYRINGE, AND THEN PLEURAL EFFUSION WAS ASPIRATED. PLEASE PROVIDE SPECIFICS AROUND ANY QUALITY ISSUE BEING REPORTED FOR THE PN120? --- THE DOCTOR COMMENTED THAT THERE WAS NO ANOMALIES NOTED FOR VISUAL AND FUNCTIONAL. WAS THE STOPCOCK IN THE OPEN OR CLOSED POSITION? ---THE STOPCOCK WAS IN THE OPEN POSITION. IS THE PATIENT EXPECTED TO HAVE A FULL RECOVERY? ---YES. WHAT IS THE PATIENT'S CURRENT STATUS? ---WELL. WHAT IS THE PATIENT'S SEX, AGE, AND WEIGHT? ---PATIENT ID (B)(6), SEX MALE, (B)(6) , HISTORY PNEUMOCONIOSIS, BENIGN ASBESTOSIS, THORACOSCOPY OF RIGHT LUNG. IN ADDITION, A COPY OF THE INSTRUCTIONS FOR USE WERE SENT WITH THE REQUEST FOR ADDITIONAL DETAILS.
Patient 1
(B)(4). THE DEVICE WAS RETURNED FOR ANALYSIS WITH DRIED BODY FLUIDS ON THE NEEDLE. BASED UPON THE VISUAL AND FUNCTIONAL EXAMINATION, IT WAS CONCLUDED THAT THE AIR FLOW AND RETURN SPRING FORCE WERE NORMAL THE DEVICE IS FULLY CONFORMING. ANALYSIS OF THE DEVICE FOUND IT FULLY FUNCTIONAL. UNABLE TO CONFIRM CUSTOMER'S COMPLAINT. THE BATCH RECORD WAS REVIEWED AND NO ANOMALIES WERE NOTED DURING THE MANUFACTURING PROCESS.