MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2013-08-23 for PUNCH 3712038 CUTTING CIRCULAR 3.5MM manufactured by Medtronic Xomed, Inc..
[3586595]
It was reported that the device broke. It was confirmed with the facility that intra-operatively the device stopped working, it would not open or close, and the physician discontinued use. There were no fragments or pieces that broke off. There was no patient impact. When received for analysis it was found that there was a piece that had broken off/detached from the device.
Patient Sequence No: 1, Text Type: D, B5
[11073541]
This device is used for therapeutic purposes. (b)(4). Product evaluation: when received for product analysis there was evidence of customer use; wear marks on working surfaces. When compared to the assembly drawing: the inner shaft broke resulting in a 0. 542? Portion of the tip becoming detached. When viewed under magnification, the break point had pitting which is consistent with rust/corrosion. Without the lot number the age of the device cannot be determined. Method code: microscopic inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00498 |
| MDR Report Key | 3304699 |
| Report Source | 05,06,07 |
| Date Received | 2013-08-23 |
| Date of Report | 2013-08-06 |
| Date of Event | 2013-07-17 |
| Date Mfgr Received | 2013-08-06 |
| Date Added to Maude | 2013-11-21 |
| 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 | MICHELLE ALFORD |
| 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 | PUNCH 3712038 CUTTING CIRCULAR 3.5MM |
| Generic Name | PUNCH, NASAL |
| Product Code | KAY |
| Date Received | 2013-08-23 |
| Returned To Mfg | 2013-07-29 |
| Model Number | 3712038 |
| Catalog Number | 3712038 |
| Lot Number | NI |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MEDTRONIC XOMED, INC. |
| Manufacturer Address | 6743 SOUTHPOINT DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-08-23 |