SYMMETRY RHOTON
Report
- Report Number
- 3007208013-2023-00017
- Event Type
- Malfunction
- Date Received
- April 19, 2023
- Report Date
- May 11, 2023
- Manufacturer
- SYMMETRY SURGICAL INC
- Product Code
- GZX
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- 003
Narratives
IT IS UNKNOWN WHEN THE DEVICE WAS PURCHASED AS THERE IS NO HISTORY OF THE CUSTOMER PURCHASING THIS DEVICE IN OUR CURRENT SYSTEM THAT HAS BEEN IN PLACE SINCE 2012. WE HAVE NOT RECEIVED THE DEVICE BACK OR RECEIVED PICTURES TO CONFIRM THE LOT NUMBER AND AGE OF THE DEVICE. IT IS UNKNOWN IF THE DEVICE IS ABLE TO BE RETURNED. WE WILL CONTINUE TO ATTEMPT IN GATHERING ADDITIONAL INFORMATION FOR FURTHER INVESTIGATION. THERE HAS BEEN A TOTAL OF (B)(4) SOLD OF ALL LOTS WITH NO ADDITIONAL COMPLAINT RECORDED FOR THIS OCCURRENCE. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE ADDITIONAL INFORMATION IS AVAILABLE.
AFTER MULTIPLE ATTEMPTS, NO FURTHER INFORMATION WAS RECEIVED REGARDING THIS COMPLAINT INVESTIGATION. THERE IS NO HISTORY OF THE DEVICE PURCHASE IN OUR ERP SYSTEM. THIS INDICATES THAT THE DEVICE WAS PURCHASED PRIOR TO DECEMBER 2012. THE CUSTOMER WILL BE PURCHASING NEW INSTRUMENTS TO REPLACE THE DEVICE THAT BROKE. A TRUE ROOT CAUSE COULD NOT BE DETERMINED AS THE DEVICE WAS NOT RETURNED FOR EVALUATION. THIS CAN BE SEEN AS THE FINAL REPORT. IF ADDITIONAL INFORMATION IS OBTAINED THAT ALLEGES ANY ADDITIONAL PATIENT INVOLVEMENT OR ADDITIONAL INFORMATION PERTINENT TO THE INVESTIGATION, A FOLLOW UP REPORT WILL BE SUMBITTED.
THE CUSTOMER ALLEGED THAT THE 80-1691 DISSECTOR BROKE OFF AND FELL INTO THE PATIENT. THEY WERE ABLE TO FISH IT OUT WITH NO FURTHER HARM TO THE PATIENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1685513 | SYMMETRY RHOTON | DISSECTOR | GZX | SYMMETRY SURGICAL INC |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |