10/CA LAPAROVUE VISIBILITY SYS
Report
- Report Number
- 3007305485-2022-00030
- Event Type
- Malfunction
- Date Received
- March 8, 2022
- Date of Event
- February 17, 2022
- Report Date
- April 21, 2022
- Manufacturer
- CONSOLIDATED MEDICAL EQUIPMENT COMPANY
- Product Code
- GCJ
- UDI-DI
- 20845854061746
- PMA / PMN Number
- K150569
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
THE REPORTED DEVICE IS BEING RETURNED TO CONMED 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.
CORRECTION: D2 AND FDA PRODUCT CODE WERE CORRECTED FROM LKF TO GCJ - LAPAROSCOPE, GENERAL & PLASTIC SURGERY. REPORTED EVENT IS CONFIRMED. CUSTOMER EVENT ¿TIP OF THE PORT CLEANER CAME COMPLETELY OFF THE STICK HANDLE¿ WAS CONFIRMED BASED ON PHOTOGRAPHIC EVIDENCE AND DEVICE EVALUATION. A VISUAL INSPECTION WAS PERFORMED, THE CLEANING SPONGE WAS DISASSEMBLED FROM THE STICK HANDLE. THE MANUFACTURING DOCUMENTS FROM THE DEVICE HISTORY RECORD HAVE BEEN REVIEWED WITH SPECIAL ATTENTION TO THE MANUFACTURING AND INSPECTION OF THE PRODUCT. THE PRODUCT RELEASED FOR DISTRIBUTION WAS FOUND TO HAVE MET ALL SPECIFICATIONS PRIOR TO SHIPMENT. THIS IS THE ONLY COMPLAINT FOR THIS LOT NUMBER AND FAILURE MODE WITHIN THE PAST TWO YEARS. A TWO-YEAR REVIEW OF COMPLAINT HISTORY REVEALED THERE HAS BEEN A TOTAL OF 15 REPORTS, REGARDING 15 DEVICES, FOR THIS DEVICE FAMILY AND FAILURE MODE. DURING THIS SAME TIME FRAME (B)(4) DEVICES HAVE BEEN MANUFACTURED AND SHIPPED WORLDWIDE. SHOULD ALL THE COMPLAINT DEVICES HAVE BEEN FOUND CONFIRMED FOR THIS REPORTED FAILURE, THE RATE OF FAILURE WOULD BE (B)(4). PER THE INSTRUCTIONS FOR USE, THE USER IS ADVISED THE FOLLOWING: GRASP HANDLE AND PUSH FOAM HEAD STRAIGHT INTO THE TROCAR. DO NOT RELEASE OR BEND THE VUETIP® TROCAR SWAB. THIS ISSUE WILL CONTINUE TO BE MONITORED THROUGH THE COMPLAINT SYSTEM TO ASSURE PATIENT SAFETY.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, LAPVUE10, 10/CA LAPAROVUE VISIBILITY SYS WAS BEING USED ON (B)(6) 2022 DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE AND ¿A TIP OF THE PORT CLEANER CAME COMPLETELY OFF THE STICK HANDLE AND HAD TO BE RETRIEVED WITH AN INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS NO REPORT OF A DELAY TO THE PROCEDURE. THE TAMPON TIP WAS PULLED BACK OUT WITH LAPAROSCOPIC GRASPERS. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
THE SALES REPRESENTATIVE REPORTED ON BEHALF OF THE CUSTOMER THAT THE DEVICE, LAPVUE10, 10/CA LAPAROVUE VISIBILITY SYS WAS BEING USED ON 17FEB22 DURING A LAPAROSCOPIC GASTRECTOMY PROCEDURE AND ¿A TIP OF THE PORT CLEANER CAME COMPLETELY OFF THE STICK HANDLE AND HAD TO BE RETRIEVED WITH AN INSTRUMENT.¿ THE PROCEDURE WAS COMPLETED WITHOUT AN ALTERNATE DEVICE AND THERE WAS NO REPORT OF A DELAY TO THE PROCEDURE. THE TAMPON TIP WAS PULLED BACK OUT WITH LAPAROSCOPIC GRASPERS. THIS REPORT IS BEING RAISED ON THE BASIS OF MALFUNCTION WITH POTENTIAL FOR INJURY UPON REOCCURRENCE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 136869 | 10/CA LAPAROVUE VISIBILITY SYS | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | LAPVUE10 | 202008146 | 20845854061746 |
| 2627922 | 10/CA LAPAROVUE VISIBILITY SYS | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | CONSOLIDATED MEDICAL EQUIPMENT COMPANY | LAPVUE10 | 202008146 | 20845854061746 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |