LOOP OSTOMY ROD
Received Apr 18, 2012 · Event occurred Apr 12, 2011
Report 2243969-2012-00025 · MDR key 2559791
Product problems
- Crack
- Material Fragmentation
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SWIVEL END BREAKS INTO PIECES WHEN OPENED. NO HARM OR INJURY TO THE PT WAS REPORTED. THIS WAS DEEMED A SERIOUS MALFUNCTION BECAUSE OF THE POSSIBLE DANGER OF A BROKEN PIECE OF THE LOOP ROD FALLING INTO THE ABDOMINAL CAVITY DURING THE SURGICAL PROCEDURE WHEN THE STOMA IS TREATED WHICH COULD REQUIRE MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY. DURING A ROUTINE REVIEW OF OUR COMPLAINT CODES, WHICH INSURES THE ROBUSTNESS AND SUSTAINED PERFORMANCE OF THE COMPLAINT HANDLING PROCESS, IT WAS DISCOVERED THAT THIS COMPLAINT CODE TYPE ("BROKEN CRACKED" FOR THE LOOP OSTOMY ROD) WAS CAPTURED AS A "PRODUCT ISSUE" AND THAT, IN THIS CASE, THIS SHOULD HAVE BEEN CAPTURED AS A POTENTIALLY REPORTABLE MALFUNCTION, WHICH MAY REQUIRE MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY. THIS COMPLAINT CODE HAS SINCE BEEN UPDATED ACCORDINGLY IN OUR COMPLAINT HANDLING SYSTEM. A RETROSPECTIVE SEARCH OF OUR COMPLAINT RECORDS CONFIRMED THAT THIS WAS THE ONLY POTENTIALLY REPORTABLE MALFUNCTION, THAT NO OTHER PREVIOUS COMPLAINTS WERE CAPTURED AS A "PRODUCT ISSUE" REPORTED TO THE FDA ON APRIL 18, 2012. (B)(4).