| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | CNO11, GELPOINT PATH 5.5CM | FER | APPLIED MEDICAL RESOURCES | FER | 18 | 18 | 1263321 | Y | N |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2016-06-21 | 0 |
Patient 1
THE INCIDENT DEVICE IS ANTICIPATED TO RETURN. A FOLLOW-UP REPORT WILL BE PROVIDED UPON COMPLETION OF THE INVESTIGATION. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THE INITIAL REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.
Patient 1
PARASTOMAL HERNIA AND PROCTECTOMY - "THE GEL POINT PATH WAS USED WITH 1 X LOW PROFILE Z-THREAD AND THE 2 SLEEVES/ TROCARS PRESENT IN THE PACKAGE. AROUND 3 HOURS INTO THE PROCEDURE (AFTER MULTIPLE MOVEMENT/ MIGRATION OF THE Z-THREAD DUE TO SCOPE CLEANING) THE Z-THREAD COMPLETELY CAME OUT OF THE GEL ALONG WITH THE CAMERA. MR (B)(6) REINSERTED THE PORT IMMEDIATELY. 10-15 MINUTES LATER IT WAS APPARENT (DUE TO THE NOISE) THAT A GAS LEAK WAS PRESENT. THERE SEEMED TO BE A SLIGHT TEAR/RIP IN THE GEL WHICH WAS VISIBLE TO THE EYE. THE GAS LEAK FROM THE TEAR PROGRESSIVELY GOT WORSE, MAKING A 'BUBBLING EFFECT' ON ONE OCCASION. AT THE END OF THE PROCEDURE WHEN SUCTION IRRIGATION WAS USED, FLUID WAS 'OOZING' FROM THE TEAR SITE. THE INCIDENT DID NOT AFFECT THE PROCEDURE OUTCOME." ADDITIONAL INFORMATION RECEIVED VIA EMAIL JUNE 14, 2016: "QUESTION FROM CLINICAL DEVELOPMENT: ALSO WOULD BE GOOD TO KNOW IF DR. (B)(6) REINSERTED THE Z-THREAD IN THE SAME HOLE AS BEFORE OR IN A NEW PLACEMENT IN THE GEL: "MY INITIAL REACTION WOULD BE NO HE DID NOT (AS THE HOLE WHICH GAS WAS LEAKING OUT OF WAS SLIGHTLY ABOVE THE Z-THREAD TROCAR)." PATIENT STATUS- "HEALTHY."
Patient 1
INVESTIGATION SUMMARY: ONE (1) GELSEAL CAP, FOUR (4) 10MM TROCAR SLEEVES, ONE (1) ACCESS CHANNEL, ONE (1) INTRODUCER, AND ONE (1) OBTURATOR WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING OBSERVED SLEEVE INSERTIONS AT THREE DIFFERENT SITES ON THE GELSEAL CAP. HOWEVER, TWO OF THESE HAD MULTIPLE THROUGH HOLES, SHOWING THAT THE SLEEVE HAD BEEN REMOVED AND REINSERTED. NO DAMAGES OR DEFECTS WERE NOTED ON THE FOUR TROCAR SLEEVES, ACCESS CHANNEL, INTRODUCER, AND OBTURATOR. A LEAK TEST WAS CONDUCTED AND ENGINEERING NOTED LEAKING SOUNDS FROM ONE OF THE THREE SITES THAT SHOWED MULTIPLE SLEEVE INSERTIONS. ENGINEERING CONFIRMED THE "BUBBLING EFFECT" OBSERVED DURING THE EVENT. THE ROOT CAUSE OF THE "BUBBLING EFFECT" IS MOST LIKELY DUE TO MULTIPLE ATTEMPTS OF MIGRATION AND PLACEMENT OF THE SLEEVES. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. IN ACCORDANCE TO 21 CFR 803.56, IF WE OBTAIN ADDITIONAL INFORMATION, WHICH WAS NOT KNOWN OR WAS NOT AVAILABLE WHEN THIS REPORT WAS SUBMITTED, THEN THE SUPPLEMENTAL REPORT WILL BE SUBMITTED TO THE FDA.
Patient 1
INVESTIGATION SUMMARY: ONE (1) GELSEAL CAP, FOUR (4) 10 MM TROCAR SLEEVES, ONE (1) ACCESS CHANNEL, ONE (1) INTRODUCER, AND ONE (1) OBTURATOR WERE RETURNED FOR EVALUATION. UPON VISUAL INSPECTION, ENGINEERING OBSERVED SLEEVE INSERTIONS AT THREE DIFFERENT SITES ON THE GELSEAL CAP. HOWEVER, TWO OF THESE HAD MULTIPLE THROUGH HOLES, SHOWING THAT THE SLEEVE HAD BEEN REMOVED AND REINSERTED. NO DAMAGES OR DEFECTS WERE NOTED ON THE FOUR TROCAR SLEEVES, ACCESS CHANNEL, INTRODUCER, AND OBTURATOR. A LEAK TEST WAS CONDUCTED AND ENGINEERING NOTED LEAKING SOUNDS FROM ONE OF THE THREE SITES THAT SHOWED MULTIPLE SLEEVE INSERTIONS. ENGINEERING CONFIRMED THE "BUBBLING EFFECT" OBSERVED DURING THE EVENT. THE ROOT CAUSE OF THE "BUBBLING EFFECT" IS MOST LIKELY DUE TO MULTIPLE ATTEMPTS OF MIGRATION AND PLACEMENT OF THE SLEEVES. APPLIED MEDICAL WILL CONTINUE TO MONITOR ITS VIGILANCE SYSTEM FOR TRENDS AND TAKE APPROPRIATE ACTIONS AS NECESSARY. THIS REPORT IS BEING FILED AS A RESULT OF A RE-REVIEW OF APPLIED MEDICAL COMPLAINTS RECEIVED BETWEEN JUNE 1, 2014 AND MAY 31, 2016. THIS RETROSPECTIVE REVIEW WAS ASSOCIATED WITH A QUALITY MANAGEMENT SYSTEM (QMS) COMPLIANCE ACTION PLAN DEVELOPED AND PRESENTED TO FDA TO ADDRESS AN APRIL 10, 2015 WARNING LETTER. APPLIED MEDICAL HAS REVISED ITS MDR REPORTING CRITERIA TO BE MORE CONSERVATIVE AND HAS IMPROVED COMPLAINT HANDLING AND MDR REPORTING PROCESSES. THE REVIEWS ENSURED THAT RECENT REPORTABLE EVENTS WERE APPROPRIATELY IDENTIFIED AND REPORTED TO THE DESIGNATED REGULATORY AUTHORITY(IES). THIS REPORT, WHICH REPRESENTS THE INITIAL AND FINAL REPORTS COMBINED, IS BEING SUBMITTED BASED ON THE FINDINGS OF THAT RETROSPECTIVE REVIEW.
Patient 1
PROCEDURE PERFORMED UNKNOWN - "THE GEL POINT PATH WAS USED WITH 1 X LOW PROFILE Z-THREAD AND THE 2 SLEEVES/ TROCARS PRESENT IN THE PACKAGE. AROUND 3 HOURS INTO THE PROCEDURE (AFTER MULTIPLE MOVEMENT/ MIGRATION OF THE Z-THREAD DUE TO SCOPE CLEANING) THE Z-THREAD COMPLETELY CAME OUT OF THE GEL ALONG WITH THE CAMERA. MR (B)(6) REINSERTED THE PORT IMMEDIATELY. 10-15 MINUTES LATER IT WAS APPARENT (DUE TO THE NOISE) THAT A GAS LEAK WAS PRESENT. THERE SEEMED TO BE A SLIGHT TEAR/RIP IN THE GEL WHICH WAS VISIBLE TO THE EYE. THE GAS LEAK FROM THE TEAR PROGRESSIVELY GOT WORSE, MAKING A 'BUBBLING EFFECT' ON ONE OCCASION. AT THE END OF THE PROCEDURE WHEN SUCTION IRRIGATION WAS USED, FLUID WAS 'OOZING' FROM THE TEAR SITE. THE INCIDENT DID NOT AFFECT THE PROCEDURE OUTCOME."