MOUNT 1352277 QUICK-LOCK SPECULUM
Received Mar 12, 2022 · Event occurred Feb 17, 2022
Report 3014334038-2022-00049 · MDR key 13742950
Device
Product problems
- Break
- Break
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
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
THIS IS 1 OF 3 LINKED TO MFG REPORT NUMBERS: 3014334038-2022-00048, 3014334038-2022-00050. A FACILITY REPORTED THAT THE QUICK-LOCK SPECULUM MOUNT (1352277) 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
THE QUICK-LOCK SPECULUM MOUNT (1352277) WAS RETURNED FOR EVALUATION: FAILURE ANALYSIS - EVALUATION WAS UNABLE TO CONCLUSIVELY VERIFY CUSTOMER INFORMATION AS VALID. THE MOUNT WAS UNDAMAGED AND NO DEFECT WAS FOUND. TESTED WITHIN SPECIFICATIONS. ROOT CAUSE - THE RETURNED 1352277 MOUNT IS IN USED CONDITION WITH NO VISIBLE DEFECT. THE MOUNT WAS ATTACHED TO 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.