AIRSEAL 12/100MM LPI PORT
Report
- Report Number
- 3007305485-2021-00433
- Event Type
- Injury
- Date Received
- December 14, 2021
- Date of Event
- November 18, 2021
- Report Date
- January 26, 2022
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- HIF
- PMA / PMN Number
- K143404
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
ADDITIONAL PRODUCT CODE; GCJ. AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RECEIVED INTO CONMED¿S COMPLAINT SYSTEM FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
ADDITIONAL PRODUCT CODE; GCJ. AT TIME OF FILING, ALTHOUGH EXPECTED, THE REPORTED DEVICE HAS NOT BEEN RECEIVED INTO CONMED¿S COMPLAINT SYSTEM FOR EVALUATION. A SUPPLEMENTAL AND FINAL REPORT WILL BE FILED FOLLOWING THE COMPLETION OF THE DEVICE EVALUATION AND COMPLAINT INVESTIGATION. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
D2: ADDITIONAL PRODUCT CODE; GCJ. H10: THE INVESTIGATION OF THE CUSTOMER'S REPORTED ISSUE FINDS IT TO BE CONFIRMED BASED ON EVALUATION OF RETURNED DEVICE. CONMED RECEIVED ONE IAS12-100LPI IN OPENED ORIGINAL PACKAGING. THE LOT NUMBER OF THE DEVICE WAS VERIFIED BASED ON RETURN PACKAGING. A VISUAL INSPECTION WAS PERFORMED, THE TROCAR IS BROKEN AT THE DISTAL END. THE PIECES THAT BROKE OFF WERE NOT RETURNED WITH THE DEVICE. THE RETURNED DEVICE EXHIBITS THE REPORTED CLAIM, NEVERTHELESS A ROOT CAUSE CANNOT BE ESTABLISHED. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED AND FOUND NO ABNORMALITIES THAT WOULD CONTRIBUTE TO THIS ISSUE. (B)(4). THE INSTRUCTIONS FOR USE (IFU) PROVIDES THE USER WITH INFORMATION REGARDING PROPER CARE AND USE OF THIS DEVICE. ALSO, PER THE IFU, THE USER IS ADVISED TO USE EXTREME CAUTION DURING AIRSEAL ACCESS PORT INSERTION. IMPROPER USE OF THIS PRODUCT CAN RESULT IN LIFE-THREATENING INJURY TO INTERNAL ORGANS AND VESSELS. ENSURE THAT ADEQUATE PNEUMOPERITONEUM OR PNEUMORECTUM IS ESTABLISHED; ENSURE THAT THE PATIENT IS PROPERLY POSITIONED SO THAT ORGANS ARE AWAY FROM THE PENETRATION SITE; DIRECT THE AIRSEAL ACCESS PORT¿S TIP AWAY FROM SIGNIFICANT VESSELS AND ORGANS; DO NOT USE EXCESSIVE DOWNWARD FORCE. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
ON BEHALF OF THE CUSTOMER, CONMED (B)(4) RECEIVED NOTICE OF REPORTED ISSUES WITH THE IAS12-100LPI, AIRSEAL 12/100MM LPI PORT, LOT 202106114, THAT (B)(6) HOSPITAL RECENTLY EXPERIENCED ON (B)(6) 2021. INFORMATION RECEIVED INDICATES DURING A ROBOT ASSISTED GASTRECTOMY, IT WAS FOUND THE TIP OF TROCAR CRACKED AT THE TIME OF POSTOPERATIVE CLOSURE. DEBRIS MAY REMAIN IN THE PATIENT'S BODY. IT IS NOTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. ADDITIONAL INFORMATION RECEIVED NOTES THE SURGEON IS NOT SURE WHEN THE DEVICE WAS BROKEN. GRASPING FORCEPS, NEEDLEHOLDER, SIGNIA (BRAND NAME), ECHERON (BRAND NAME) INSTRUMENTS HAD BEEN INSERTED/WITHDRAWN USING THE PORT PRIOR TO THE ISSUE BEING DETECTED. IT IS NOTED THERE IS A CHIP MISSING OUT OF THE TIP AND THE PIECE HAD NOT BEEN FOUND. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS IT IS NOTED DEBRIS MAY REMAIN IN THE PATIENT¿S BODY.
ON BEHALF OF THE CUSTOMER, CONMED (B)(4) RECEIVED NOTICE OF REPORTED ISSUES WITH THE IAS12-100LPI, AIRSEAL 12/100MM LPI PORT, LOT 202106114, THAT (B)(6) HOSPITAL RECENTLY EXPERIENCED ON (B)(6) 2021. INFORMATION RECEIVED INDICATES DURING A ROBOT ASSISTED GASTRECTOMY, IT WAS FOUND THE TIP OF TROCAR CRACKED AT THE TIME OF POSTOPERATIVE CLOSURE. DEBRIS MAY REMAIN IN THE PATIENT'S BODY. IT IS NOTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. ADDITIONAL INFORMATION RECEIVED NOTES THE SURGEON IS NOT SURE WHEN THE DEVICE WAS BROKEN. GRASPING FORCEPS, NEEDLEHOLDER, SIGNIA (BRAND NAME), ECHERON (BRAND NAME) INSTRUMENTS HAD BEEN INSERTED/WITHDRAWN USING THE PORT PRIOR TO THE ISSUE BEING DETECTED. IT IS NOTED THERE IS A CHIP MISSING OUT OF THE TIP AND THE PIECE HAD NOT BEEN FOUND. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS IT IS NOTED DEBRIS MAY REMAIN IN THE PATIENT¿S BODY.
ON BEHALF OF THE CUSTOMER, CONMED JAPAN RECEIVED NOTICE OF REPORTED ISSUES WITH THE IAS12-100LPI, AIRSEAL 12/100MM LPI PORT, LOT 202106114, THAT (B)(6) HOSPITAL RECENTLY EXPERIENCED ON (B)(6) 2021. INFORMATION RECEIVED INDICATES DURING A ROBOT ASSISTED GASTRECTOMY, IT WAS FOUND THE TIP OF TROCAR CRACKED AT THE TIME OF POSTOPERATIVE CLOSURE. DEBRIS MAY REMAIN IN THE PATIENT'S BODY. IT IS NOTED THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH NO REPORTED DELAY. ADDITIONAL INFORMATION RECEIVED NOTES THE SURGEON IS NOT SURE WHEN THE DEVICE WAS BROKEN. GRASPING FORCEPS, NEEDLEHOLDER, SIGNIA (BRAND NAME) ECHERON(BRAND NAME) INSTRUMENTS HAD BEEN INSERTED/WITHDRAWN USING THE PORT PRIOR TO THE ISSUE BEING DETECTED. IT IS NOTED THERE IS A CHIP MISSING OUT OF THE TIP AND THE PIECE HAD NOT BEEN FOUND. THIS REPORT IS BEING RAISED ON THE BASIS OF INJURY AS IT IS NOTED DEBRIS MAY REMAIN IN THE PATIENT¿S BODY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1895169 | AIRSEAL 12/100MM LPI PORT | INSUFFLATOR, LAPAROSCOPIC | HIF | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | 202106114 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |