VERSAONE
Report
- Report Number
- 9612501-2024-02080
- Event Type
- Malfunction
- Date Received
- August 14, 2024
- Date of Event
- July 11, 2024
- Report Date
- December 19, 2024
- Manufacturer
- DAVIS & GECK CARIBE LTD
- Product Code
- GCJ
- UDI-DI
- 10884521657687
- PMA / PMN Number
- K130435
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BR
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THE OBTURATOR WAS RECEIVED INSERTED IN TO THE CANNULA, PROLONGED INSERTION CAN CAUSE THE DUCKBILL SEAL TO BECOME STRETCHED. THE SEAL HOUSING AND CANNULA APPEARED INTACT. THE CIRCULAR SEAL AND DUCKBILL SEAL WERE VISIBLY STRETCHED OUT. FUNCTIONALLY, THE DEVICE FAILED AN AIR LEAK TEST. THE PRODUCT WAS SHIPPED BACK WITH THE OBTURATOR INSERTED IN THE CANNULA AND THEREFORE THE LENGTH OF TIME IT WAS INSERTED DURING SHIPMENT MAY HAVE ALSO RESULTED IN THE STRETCHED SEALS. THE SEAL HOUSING WAS BROKEN OPEN TO REMOVE THE CIRCULAR SEAL TO CHECK FOR SUBASSEMBLY OVERALL HEIGHT. (255 MAX - 245 MIN) THE MEASUREMENTS WITH CALIPERS WERE, 255, 254, 253, 255, 255, 255. IT WAS REPORTED THAT THERE WAS A RAPID LOSS OF PNEUMOPERITONEUM. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. IT WAS ALSO REPORTED THAT THE DEVICE LEAKED AIR. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ADDITIONAL INFORMATION: H6 (FDR) H3 EVALUATION SUMMARY: MEDTRONIC CONDUCTED AN INVESTIGATION BASED UPON ALL INFORMATION RECEIVED. THE DEVICE WAS AVAILABLE FOR EVALUATION. VISUAL INSPECTION NOTED THAT THE OBTURATOR WAS RECEIVED INSERTED IN TO THE CANNULA, PROLONGED INSERTION CAN CAUSE THE DUCKBILL SEAL TO BECOME STRETCHED. THE SEAL HOUSING AND CANNULA APPEARED INTACT. THE CIRCULAR SEAL AND DUCKBILL SEAL WERE VISIBLY STRETCHED OUT. FUNCTIONAL TESTING FOUND THAT THE DEVICE FAILED AN AIR LEAK TEST. THE PRODUCT WAS SHIPPED BACK WITH THE OBTURATOR INSERTED IN THE CANNULA AND THEREFORE THE LENGTH OF TIME IT WAS INSERTED DURING SHIPMENT MAY HAVE ALSO RESULTED IN THE STRETCHED SEALS. THE SEAL HOUSING WAS BROKEN OPEN TO REMOVE THE CIRCULAR SEAL TO CHECK FOR SUBASSEMBLY OVERALL HEIGHT. (255 MAX - 245 MIN) THE MEASUREMENTS WITH CALIPERS WERE, 255, 254, 253, 255, 255, 255. IT WAS REPORTED THAT THERE WAS A RAPID LOSS OF PNEUMOPERITONIUM. THE REPORTED ISSUE COULD NOT BE CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. IT WAS ALSO REPORTED THAT WERE LEAKS. THE REPORTED ISSUE WAS CONFIRMED. THE MOST LIKELY CAUSE COULD NOT BE ESTABLISHED FROM THE INFORMATION AVAILABLE. THE MANUFACTURING RECORDS FOR EACH DEVICE ARE THOROUGHLY REVIEWED PRIOR TO RELEASE TO ENSURE THAT IT MEETS ALL MEDTRONIC QUALITY SPECIFICATIONS. A SECONDARY REVIEW OF THE DEVICE HISTORY RECORDS FOUND NO POTENTIALLY CONTRIBUTING FACTORS. MEDTRONIC SUBMITS THIS REPORT TO COMPLY WITH FDA REGULATIONS 21 CFR PARTS 4 AND 803. MEDTRONIC HAS MADE REASONABLE EFFORTS TO PROVIDE AS MUCH RELEVANT INFORMATION AS IS AVAILABLE TO THE COMPANY AS OF THE SUBMISSION DATE OF THIS REPORT. THIS REPORT DOES NOT CONSTITUTE AN ADMISSION OR A CONCLUSION BY FDA, MEDTRONIC, OR ITS EMPLOYEES THAT THE DEVICE, MEDTRONIC, OR ITS EMPLOYEE CAUSED OR CONTRIBUTED TO THE EVENT DESCRIBED IN THE REPORT. ANY REQUIRED FIELDS THAT ARE UNPOPULATED ARE BLANK BECAUSE THE INFORMATION IS CURRENTLY UNKNOWN OR UNAVAILABLE. MEDTRONIC WILL SUBMIT A SUPPLEMENTAL REPORT IF ADDITIONAL RELEVANT INFORMATION BECOMES KNOWN.
ACCORDING TO THE REPORTER, DURING A LAPAROSCOPIC GASTROPLASTY PROCEDURE, THE DEVICE LEAKED AIR OR GAS HEAVILY. THIS RESULTED IN A RAPID LOSS OF PNEUMOPERITONEUM. TO RESOLVE THE ISSUE, ANOTHER DEVICE WAS USED. THERE WAS NO PATIENT INJURY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2349645 | VERSAONE | LAPAROSCOPE, GENERAL & PLASTIC SURGERY | GCJ | DAVIS & GECK CARIBE LTD | ONB12STF | J3H1493Y | 10884521657687 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Female |