YASARGIL APPL.FCPS STD.TI.90/220MM
Received Aug 22, 2017 · Event occurred Aug 16, 2017
Report 9610612-2017-00436 · MDR key 6811935
Device
Product problems
- Device Operates Differently Than Expected
- Device Operates Differently Than Expected
Patient
Not reported
- Blood Loss
- Blood Loss
Narrative
Additional Manufacturer Narrative
INVESTIGATION: THE INVESTIGATION WAS CARRIED OUT BY THE QUALITY COORDINAOR OF THE PRODUCTION PLANT. NORMAL SIGNS OF WEAR AND TEAR CAN BE FOUND ON THE SURFACE. THE DIMENSIONS W1 (CLOSED POSITION OF THE FORCEPS) AND W4 (RELEASE OF THE CLIP) ARE TRUE TO GAUGE. W2 (FUNCTION OF THE CATCH) CAN NOT BE CHECKED DUE TO THE DEFORMED CATCH. BATCH HISTORY REVIEW: THE DEVICE QUALITY AND MANUFACTURING HISTORY RECORDS HAVE BEEN CHECKED FOR THE AVAILABLE LOT NUMBERS. THE DEVICE HISTORY FILE HAS BEEN CHECKED AND FOUND TO BE ACCORDING TO OUR SPECIFICATION VALID AT THE TIME OF PRODUCTION. NO SIMILAR INCIDENTS HAVE BEEN FILED WITH PRODUCTS FROM THIS BATCH. CONCLUSION AND ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE AS WELL AS A RESULT OF OUR INVESTIGATION THE ROOT CAUSE OF THE FAILURE IS MOST PROBABLY RELATED TO AN INSUFFICIENT USAGE. RATIONAL: DUE TO THE DELIBERATED DEFORMATION OF THE CATCH, THE INSTRUMENT IS NO LONGER ACCORDING TO THE DELIVERY CONDITION. A SAFE APPLICATION OF AN ANEURYSM CLIP CAN NO LONGER BE GUARANTEED. NO CAPA IS NECESSARY.
Additional Manufacturer Narrative
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING.
Description of Event or Problem
COUNTRY OF COMPLAINT: (B)(6). IT WAS REPORTED THAT THE CLAMP PRESENTED DEFECT DURING THE SURGERY. ACCORDING TO REPORTS IT DID NOT MAKE THE CORRECT OPENING OF THE CLIP AND BECAUSE OF THIS THE BLADE OF THE CLIP PIERCED THE ANEURYSM. THE PATIENT BLEED HEAVILY AND STOPPED. THE SURGEON MANAGED THE SITUATION AND CLIPPED IT WITH ANOTHER KEY.