MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05 report with the FDA on 2007-08-02 for FIBEROPTIC CANALLCULUS INTUBATION SET 1887570 manufactured by Medtronic Ent.
[685339]
Customer reported that they had to perform a second procedure to remove broken tubing from the patient's sinus a week after the first procedure. The customer indicated that they replaced it with a similar product and the patient had no further problems. No additional information is available for further investigation.
Patient Sequence No: 1, Text Type: D, B5
[7808740]
The contact returned a clean, partial part (4") of c-flex tubing that has a pinch mark at the bottom part of the tubing. The cause of the component breakage is indeterminate.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2007-00005 |
| MDR Report Key | 888453 |
| Report Source | 05 |
| Date Received | 2007-08-02 |
| Date of Report | 2007-08-02 |
| Date Mfgr Received | 2007-07-06 |
| Device Manufacturer Date | 2006-04-24 |
| Date Added to Maude | 2007-08-07 |
| 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 | BILLY WIGGINS |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328196 |
| Manufacturer G1 | MEDTRONIC ENT |
| 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 | FIBEROPTIC CANALLCULUS INTUBATION SET |
| Generic Name | STERILE OPHTHALMIC DISPOSABLE |
| Product Code | HNW |
| Date Received | 2007-08-02 |
| Returned To Mfg | 2007-07-20 |
| Model Number | 1887570 |
| Catalog Number | 1887570 |
| Lot Number | 44222800 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| Implant Flag | N |
| Date Removed | B |
| Device Sequence No | 1 |
| Device Event Key | 867057 |
| Manufacturer | MEDTRONIC ENT |
| Manufacturer Address | JACKSONVILLE FL 32216 US |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Required No Informationntervention | 2007-08-02 |