MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 01,04,05,06,08 report with the FDA on 2011-02-01 for SICKLE AND KNIFE,DULL TIP 3714244 manufactured by Medtronic Xomed Inc..
[8949093]
(b)(6) reports that no further investigation will occur at this time. However it will continue to monitor the rate and pattern of occurrence, and may re-open the file as appropriate. The medtronic (b)(4) office is attempting to retrieve the instrument for analysis. If the instrument is returned, additional information will be submitted on a supplemental mdr. There were no reported adverse consequences to the patient, or any delay in the surgical procedure. Any missing or incomplete data on form 3500a is the result of information not being provided by the reporter. The reported item this product being used for treatment and not for diagnosis if any additional information is made available or when the product is returned for analysis a supplemental 3500a will be filed. Mdr 1045254-2011-00007 was submitted on (b)(4) 2011, and the following is a supplemental to that report. The instrument was returned on (b)(4) 2011. A visual examination of the returned product revealed the tip was broken off approximately 8. 32 mm from the tip. A magnified view of the broken sections of the tip revealed a chip had been broken out of the blade. Also noted were dents and notches along the blade edge. This would indicate the tip was damaged prior to the reported break.
Patient Sequence No: 1, Text Type: N, H10
[18961713]
(b)(6) reports that no further investigation will occur at this time. However, it will continue to monitor the rate and pattern of occurrence, and may re-open the file as appropriate. The medtronic (b)(4) office is attempting to retrieve the instrument for analysis. If the instrument is returned, additional information will be submitted on a supplemental mdr. There were no reported adverse consequences to the patient, or any delay in the surgical procedure. Any missing or incomplete data on form 3500a is the result of information not being provided by the reporter. The reported product is being used for treatment and not for diagnosis. If any additional information is made available or when the product is returned for analysis, a supplemental 3500a will be filed.
Patient Sequence No: 1, Text Type: N, H10
[19102176]
This report was forwarded from (b)(6) the (b)(4) facility. The report indicates at the beginning of an endoscopic sinus procedure, the instrument tip fractured in the patient's sinus. The surgeon retrieved the tip from the sinus as soon as it happened, without the need for additional surgical procedures or equipment.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 1045254-2011-00007 |
| MDR Report Key | 1976143 |
| Report Source | 01,04,05,06,08 |
| Date Received | 2011-02-01 |
| Date of Report | 2011-01-12 |
| Date of Event | 2010-12-29 |
| Date Mfgr Received | 2011-01-12 |
| Date Added to Maude | 2011-06-10 |
| 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 | 0 |
| Event Location | 0 |
| Manufacturer Contact | MR. MIKE MOSBY |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9042797584 |
| 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 | SICKLE AND KNIFE,DULL TIP |
| Product Code | KTG |
| Date Received | 2011-02-01 |
| Returned To Mfg | 2011-02-21 |
| Model Number | 3714244 |
| Catalog Number | 3714244 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED INC. |
| Manufacturer Address | 6743 SOUTHPOINT DR. N. JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2011-02-01 |