BLADE 1352282 O/R TABLE BRACKET
Received Mar 12, 2022 · Event occurred Feb 17, 2022
Report 3014334038-2022-00048 · MDR key 13742964
Device
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
THIS IS 2 OF 3 REPORTS LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00049, 3014334038-2022-00050. A FACILITY REPORTED THAT THE BLADE O/R TABLE BRACKET (1352282) BROKE IN THE MIDDLE OF A TYMPANOPLASTY PROCEDURE. ALL PARTS WERE RECOVERED AND WERE TAKEN OFF THE SURGICAL FIELD; NO FRAGMENTS FELL INTO THE SURGICAL SITE. IT WAS REPORTED THAT AN X-RAY WAS PERFORMED TO ASSURE THAT NO PARTS WERE LEFT IN THE PATIENT FOLLOWING THE EVENT. THE EVENT DID NOT LEAD TO PATIENT INJURY, DEATH, OR DELAY IN PROCEDURE.
Additional Manufacturer Narrative
AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.
Description of Event or Problem
N/A.
Additional Manufacturer Narrative
THE BLADE O/R TABLE BRACKET (1352282) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY CUSTOMER INFORMATION AS VALID. THE BRACKET WAS UNDAMAGED AND NO DEFECT WAS FOUND. TESTING WAS WITHIN SPECIFICATION. ROOT CAUSE - THE RETURNED 1352282 TABLE BRACKET IS IN USED CONDITION WITH NO VISIBLE DEFECT. THE BRACKET WAS IN USE WITH A BROKEN 1352275 SPECULUM ARM. THE ARM IS BEING INVESTIGATED UNDER A SEPARATE COMPLAINT. NO FURTHER INVESTIGATION REQUIRED BASED ON THE ACCEPTABILITY OF RISK AND NO ADVERSE TRENDS IDENTIFIED. THIS WILL BE MONITORED AND TRENDED GOING FORWARD.