SOLYX SIS SYSTEM
Report
- Report Number
- 3005099803-2013-02286
- Event Type
- Malfunction
- Date Received
- March 27, 2013
- Report Date
- March 1, 2013
- Manufacturer
- BOSTON SCIENTIFIC - MARLBOROUGH
- Product Code
- FTL
- PMA / PMN Number
- K081275
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- PHYSICIAN
Narratives
A REVIEW OF THE MANUFACTURING RECORDS FOR THIS LOT SHOWED NO EVIDENCE OF A MANUFACTURING-RELATED POTENTIAL CAUSE FOR THIS EVENT. VISUAL ANALYSIS OF THE RETURNED SOLYX SIS SYSTEM SHOWED THAT THE MESH IS STRETCHED AND FRAYED AT ONE END, APPROXIMATELY 2 CM FROM THE CARRIER. SINCE THE INVESTIGATION REVEALED THAT THE DAMAGE TO THE MESH OCCURRED AT THE END NEAR THE CARRIER AND NOT AT THE CENTRAL PORTION, THIS EVENT IS NO LONGER CONSIDERED REPORTABLE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE DURING A PROCEDURE USING A SOLYX SINGLE INCISION SLING SYSTEM, AS THE PHYSICIAN WENT TO PLACE THE SECOND SIDE, HE NOTICED THAT THE MESH WAS STRETCHED (SPECIFICS UNKNOWN). THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER SOLYX DEVICE. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO WAS FINE AT THE CONCLUSION OF THE PROCEDURE.
IT WAS REPORTED TO BOSTON SCIENTIFIC CORPORATION THAT THE DURING A PROCEDURE USING A SOLYX SINGLE INCISION SLING SYSTEM, AS THE PHYSICIAN WENT TO PLACE THE SECOND SIDE, HE NOTICED THAT THE MESH WAS STRETCHED (SPECIFICS UNKNOWN). THE PHYSICIAN REMOVED THE DEVICE FROM THE PATIENT AND COMPLETED THE PROCEDURE WITH ANOTHER SOLYX DEVICE. THERE WERE NO COMPLICATIONS TO THE PATIENT, WHO WAS FINE AT THE CONCLUSION OF THE PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 125806 | SOLYX SIS SYSTEM | MESH, SURGICAL, POLYMERIC | FTL | BOSTON SCIENTIFIC - MARLBOROUGH | M0068507000 | ML00000925 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |