MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07,company representati report with the FDA on 2013-03-26 for PUNCH 3712038 CUTTING CIRCULAR 3.5MM manufactured by Medtronic Xomed, Inc..
[10870795]
Device received (b)(4) 2013. Evaluation summary: product analysis found that the condition of the returned device showed customer use. From visual evaluation, the shaft at the tip was found broken approximately 11mm from the distal tip. Under magnification, the broken shaft edges were found jagged. The outer diameter of the shaft was found approximately 2. 70mm which is meets the required specification of 2. 70mm +/- 0. 50 as per assembly drawing. The tip (punch) outer diameter measured 3. 49mm which also meets the specification of 3. 50mm +/- 0. 50mm. The overall length could not be measured due to the broken shaft component. The device could not be functioned upon activation of handle due to broken shaft assembly. The breakage of the shaft appears to be related with excessive customer handling / use of the device during procedure. Method: microscopic inspection. (b)(4).
Patient Sequence No: 1, Text Type: N, H10
[20648396]
It was reported that there is a piece that is either broken or missing from the device. No reported patient impact.
Patient Sequence No: 1, Text Type: D, B5
[21113434]
This device is used for therapeutic purposes. (b)(4): evaluation summary not available, device has not been returned or evaluated at this time. Method: actual device not evaluated.
Patient Sequence No: 1, Text Type: N, H10
[102466796]
If information is provided in the future, a supplemental report will be issued.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00300 |
| MDR Report Key | 3021187 |
| Report Source | 05,06,07,COMPANY REPRESENTATI |
| Date Received | 2013-03-26 |
| Date of Report | 2013-03-04 |
| Date Mfgr Received | 2013-06-12 |
| Device Manufacturer Date | 2012-01-18 |
| Date Added to Maude | 2013-05-23 |
| 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 | 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 | 2013-03-26 |
| Returned To Mfg | 2013-05-30 |
| Model Number | 3712038 |
| Catalog Number | 3712038 |
| Lot Number | 201201MF1 |
| 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 DRIVE NORTH JACKSONVILLE FL 32216 US 32216 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2013-03-26 |