DISP.TROCAR THRD.W.DILATING PIN 12/110MM
Received Apr 21, 2016 · Event occurred Feb 24, 2016
Report 2916714-2016-00309 · MDR key 5594862
Device
Product problems
- Break
- Break
Patient
Not reported
- No Known Impact Or Consequence To Patient
- No Known Impact Or Consequence To Patient
Narrative
Additional Manufacturer Narrative
(B)(4) (IMPORTER) IS SUBMITTING THIS REPORT ON BEHALF OF AESCULAP AG (MANUFACTURER). EXEMPTION NUMBER: E2014018.
Description of Event or Problem
COUNTRY OF COMPLAINT: ITALY. DURING INSERTION OF THE PG036SU / DISP.SUCTI./IRRIG.INSTR.5/330MM W.SPIKE THE TIP OF THE TROCAR (EK236SU / DISP.TROCAR THRD.W.DILATING PIN) BROKE INTO 3 PARTS, FALLING IN THE BODY OF THE PATIENT. THE CALIBER WAS THE SMALLEST POSSIBLE AND THE OPERATOR DIDN'T APPLY ANY TYPE OF FORCE ON THE INSTRUMENT. IT WAS DIFFICULT TO FIND ALL PIECES SINCE IT IS NOT RADIOPAQUE.
Additional Manufacturer Narrative
INVESTIGATION: SEVERAL TESTS AND INVESTIGATIONS HAVE BEEN PERFORMED. UP TO NOW, ALL THE INVESTIGATIONS COULD NOT ESTABLISH A FINAL CAUSE OF THE ISSUE. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE IT IS NOT POSSIBLE TO DETERMINE A POSSIBLE ROOT CAUSE FOR THE FAILURE. WE ASSUME A MANUFACTURING, A DESIGN RELATED ERROR OR A COMBINATION OF MULTIPLE FACTORS. RATIONAL: N/A, INVESTIGATION ONGOING. CORRECTIVE ACTION ACCORDING TO SOP (B)(4) FILE WILL BE FORWARDED TO THE CRB FOR CAPA.