MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,health professional,use report with the FDA on 2012-07-31 for ELEVATOR 3714040 WOODSON DBL 10/30DEG manufactured by Xomed Micro-france Mfg.
[2736852]
It was reported that during a scheduled procedure the surgeon was using the instrument and the tip of the instrument broke in the patient. They retrieved the fragments. An x ray was done to ensure no fragments were left in the patient causing a 20 - 30 minute delay. There was no reported patient injury.
Patient Sequence No: 1, Text Type: D, B5
[10076982]
(b)(4). The product was not returned to the manufacturer for evaluation. Method/results: the product has not been returned to the manufacturer for analysis. This device is used for treatment purposes. Blank fields in this report are a result of information not provided by the physician and/or user facility. Device description: an ear, nose, and throat manual surgical instrument is one of a variety of devices intended for use in surgical procedures to examine or treat the bronchus, esophagus, trachea, larynx, pharynx, nasal and paranasal sinus, or ear. It is the responsibility of the surgical team to select the appropriate instrument for each case and check the condition of instruments before and after each case. Remove from use any incomplete or poorly operating instruments. Do not bend, pry, or use excessive force, breakage or failure of the instrument could occur resulting in possible harm to the patient or user. Inspect components for any damage before and after each use. If damage is observed do not use the instrument until it is repaired. After cleaning and sterilization, verify functionality prior to re-use.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2012-00403 |
| MDR Report Key | 2675906 |
| Report Source | 05,06,HEALTH PROFESSIONAL,USE |
| Date Received | 2012-07-31 |
| Date of Report | 2012-07-11 |
| Date of Event | 2012-07-10 |
| Date Mfgr Received | 2012-07-11 |
| Date Added to Maude | 2012-07-31 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | RAHN GREENE |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328197 |
| Manufacturer G1 | MEDTRONIC XOMED, INC. |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 32216 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVATOR 3714040 WOODSON DBL 10/30DEG |
| Generic Name | ELEVATOR, ENT |
| Product Code | KAD |
| Date Received | 2012-07-31 |
| Model Number | 3714040 |
| Catalog Number | 3714040 |
| Lot Number | NOT PROVIDED |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Age | DA |
| Device Eval'ed by Mfgr | N |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | XOMED MICRO-FRANCE MFG |
| Manufacturer Address | SAINT AUBIN-LE-MONIAL BOURBON-L'ARCHAMBAULT,FR 3160 FR 3160 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2012-07-31 |