MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06 report with the FDA on 2014-02-10 for STAINLESS STEEL RULER, 30 0MM SR manufactured by Integra Burlington Ma, Inc.
[17574717]
It was reported that the numbers at 10 cm intervals of the ruler were filled with red paint while the rest of the numbers were black. The red paint flakes off and contaminates other parts like the cannulas. The surgeon spent some time in a recent deep brain stimulation (dbs) case cleaning paint flakes from inside a cannula. Additional information was requested and on (b)(4) 2014, the following was received: the product problem occurred on (b)(6) 2013 during the preparation of dbs electrode for insertion to target depth after completion of neuron signal mapping (mer). The customer explained that using the axon instruments system, a guide tube is placed on the ruler, after having set the slider on the ruler to the target depth. Then, an adhesive paper tab is wrapped around the upper end of the guide tube to act as a temporary depth stop 5 mm above target. The dbs electrode is inserted into the guide tube and fixed in place by the adhesive tab extending past the upper end of the guide tube. In this case, the surgeon saw red paint flakes on the guide tube sometime during the above process and stopped to clean them off the surface and flush the lumen with saline. When the product problem occurred, the (b)(6) male patient was awake but sedated. Surgical delay was under 10 minutes. There was no known adverse consequence as a result of the surgical delay.
Patient Sequence No: 1, Text Type: D, B5
[17714430]
The device involved in the reported incident is not expected to be received for evaluation. An investigation has been initiated based upon the reported information.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 1222895-2014-00002 |
| MDR Report Key | 3832315 |
| Report Source | 05,06 |
| Date Received | 2014-02-10 |
| Date of Report | 2014-01-20 |
| Date of Event | 2013-12-09 |
| Date Mfgr Received | 2014-01-20 |
| Date Added to Maude | 2014-06-16 |
| 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 | ROWENA BUNUAN |
| Manufacturer Street | 315 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | STAINLESS STEEL RULER, 30 0MM |
| Generic Name | NA |
| Product Code | FTY |
| Date Received | 2014-02-10 |
| Catalog Number | SR |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA BURLINGTON MA, INC |
| Manufacturer Address | BURLINGTON MA 01803 US 01803 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2014-02-10 |