| Seq | Brand | Generic | Manufacturer | Product code | Model | Catalog | Lot | PMA | 510(k) | Implant | Evaluated | Availability |
|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | MICROFRANCE? INSTRUMENT | KNIFE, EAR | MEDTRONIC XOMED INSTRUMENTATION S.A.S | JYO | MCO5E | MCO5E | 11-06 | Y | R |
| Sequence | Received | Treatment | Outcome |
|---|---|---|---|
| 1 | 2014-10-30 | 0 |
Patient 1
IT WAS REPORTED THAT THE TIP OF THE PRODUCT BROKE OFF INTO THE PATIENT DURING THE PROCEDURE. THE INSTRUMENT BROKE INTO TWO PIECES. THEY WERE ABLE TO RETRIEVE BOTH PIECES THAT FELL INTO THE PATIENT. THIS CAUSED A DELAY OF SURGERY OF 20 MINUTES. THERE WAS NO PATIENT IMPACT.
Patient 1
THIS DEVICE IS USED FOR THERAPEUTIC PURPOSES. (B)(6).
Patient 1
ON NOVEMBER 26, 2014, ADDITIONAL INFORMATION WAS RECEIVED: "PROCEDURE- ENDOSCOPIC SINUS SURGERY. THE BROKEN PIECE FELL INTO THE ORALPHARYNX. WE HAD TO DO A LARYNGOSCOPY TO REMOVE THE PIECE THROUGH THE MOUTH." LOT # 11-06. DEVICE RETURNED TO MFR: 12/10/2014. THE INSTRUMENT WAS RETURNED FOR EVALUATION. PRODUCT ANALYSIS FOUND "THE TUBE IS BROKEN RIGHT AFTER THE WELD WITH THE HANDLE. IT IS ALSO STRONGLY BENT. NO MATERIAL OR WELDING OR MANUFACTURING DEFECT WAS FOUND. CONSIDERING THE DISTORTION OF THE TUBE AND THE AGE OF THE INSTRUMENT (8 YEARS), THE MOST PROBABLE CAUSE OF THIS RUPTURE IS THE SUCCESSIVE IMPORTANT EFFORTS [STRESS] DURING THE LIFE OF THE INSTRUMENT." DEVICE MANUFACTURE DATE: 11/2006. METHOD: ACTUAL DEVICE EVALUATED; VISUAL INSPECTION ; LABELING EVALUATION. RESULTS :STRESS PROBLEM; FATIGUE PROBLEM. CONCLUSION: USE ERROR CAUSED OR CONTRIBUTED TO EVENT.
Patient 1
ON NOVEMBER 26, 2014, ADDITIONAL INFORMATION WAS RECEIVED: "PROCEDURE- ENDOSCOPIC SINUS SURGERY. THE BROKEN PIECE FELL INTO THE ORALPHARYNX. WE HAD TO DO A LARYNGOSCOPY TO REMOVE THE PIECE THROUGH THE MOUTH."
Patient 1
IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.