InjuryMFJ
CAPIO SUTURE DEVICE
Received May 13, 2016 · Event occurred Apr 28, 2016
Report MW5062327 · MDR key 5662231
Device
Product problems
- Detachment Of Device Component
Patient
66 YR
- Device Embedded In Tissue or Plaque
- Device Embedded In Tissue or Plaque
Narrative
Description of Event or Problem
PATIENT WAS HAVING A POSTERIOR URETHROPLASTY PERFORMED. THE SURGEON WAS USING A CAPIO SUTURE DEVICE WITH A CAPIO SUTURE WHICH HAS A SH NEEDLE AT ONE END OF THE SUTURE WITH A SEPARATE 2.5MM AT THE OTHER END OF 36 INCH SUTURE. THE BULLET BECAME DETACHED FROM THE SUTURING DEVICE WHILE IN THE PATIENT. THE SURGEONS WERE NOT ABLE TO RETRIEVE THE SMALL BULLET FROM THE SCAR TISSUE AREA BECAUSE OF POTENTIAL HARM TO THE PATIENT.