MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 06 report with the FDA on 2013-04-22 for SUCTION 3724222 HOUSE IRRIGATOR 5X7FR manufactured by Medtronic Xomed, Inc..
[3431423]
It was reported there was an issue with four instruments at a cadaver lab in the same day. The head of the irrigation port is broke off of two of the instruments. The other two are bent. This happened during use of the instruments. There were no patients involved in the case, used in a cadaver lab.
Patient Sequence No: 1, Text Type: D, B5
[10779750]
Blank fields on this report are the result of information not being provided by initial reporter. This device is used for therapeutic purposes. Part # 3724225, suction house irrigator 8x12fr, qty of 2, lot #, serial #, and manufacture date unknown. (b)(4). The quality engineer reviewed the returned instruments and concluded that the damage is most likely due to excessive force from the end user. With the exception of the bends or breaks defined in the complaint, the remainder of the instruments is intact and no visible damage is seen. The remainders of the instruments meet specifications. The irrigation ports are attached to stainless steel tubing, which in itself provides good support and does not bend easily. One irrigation port had the weld break and it came off the stainless steel tubing. The second unit had both the weld and the stainless steel tubing break off, which support the conclusion of excessive force being used. Results - stress problem (b)(4).
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1045254-2013-00343 |
| MDR Report Key | 3071103 |
| Report Source | 06 |
| Date Received | 2013-04-22 |
| Date of Report | 2013-03-29 |
| Date Mfgr Received | 2013-03-29 |
| Date Added to Maude | 2013-06-24 |
| 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 | CHRISTY CAIN |
| Manufacturer Street | 6743 SOUTHPOINT DRIVE NORTH |
| Manufacturer City | JACKSONVILLE FL 32216 |
| Manufacturer Country | US |
| Manufacturer Postal | 32216 |
| Manufacturer Phone | 9043328353 |
| 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 | SUCTION 3724222 HOUSE IRRIGATOR 5X7FR |
| Generic Name | TUBE, EAR SUCTION |
| Product Code | JZF |
| Date Received | 2013-04-22 |
| Returned To Mfg | 2013-04-09 |
| Model Number | 3724222 |
| Catalog Number | 3724222 |
| Lot Number | NOT PROVIDED |
| 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 | 2013-04-22 |