JAW INS.MARYLAND DISSECTOR 3.5MM 290MM
Received Jan 31, 2018 · Event occurred Jan 9, 2018
Report 9610612-2018-00024 · MDR key 7232641
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
EXEMPTION NUMBER: E2014018. MANUFACTURING SITE EVALUATION: EVALUATION ON-GOING
Description of Event or Problem
(B)(6). DURING THE PROCEDURE FOR OVARIAN CYSTECTOMY, THE JAW WAS BROKEN TO PIECES BY HOLDING MEMBRANE TISSUE AND PULLING IT UP. THE BROKEN PARTS DROPPED INSIDE OF THE PATIENT. THE CUSTOMER MANAGED TO REMOVE THE BROKEN PARTS, HOWEVER, A FRAGMENT APPROX. 2MM LENGTH WAS FOUND INSIDE OF THE PATIENT BY X-RAY AFTER SURGERY.
Additional Manufacturer Narrative
INVESTIGATION: THE COMPONENTS HAVE BEEN EXAMINED VISUALLY AND MICROSCOPICALLY WITH A PANASONIC DMC TZ8 DIGITAL CAMERA. CONCLUSION AND ROOT CAUSE: THE ROOT CAUSE OF THE PROBLEM IS MOST PROBABLY USAGE RELATED. RATIONAL: ACCORDING TO THE QUALITY STANDARD AND DHR FILES, A MATERIAL DEFECT OR PRODUCTION ERROR CAN BE EXCLUDED. ADDITIONALLY ACCORDING TO THE REPORT OF THE QUALITY ASSURANCE OF THE PRODUCTION DEPARTMENT THERE IS NO PRODUCTION ERROR. THE BREAKAGE WAS CAUSED BY EXCESSIVE LATERAL STRESS. NO CAPA IS NECESSARY.