MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2015-11-09 for ELEVATOR 3714383 GORNEY SUCTION 3MM TIP manufactured by Integra York, Pa Inc..
[30836921]
The device involved in the reported incident is not available for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[30836922]
Customer initially reports surgeon using instrument during procedure, it broke at handle, tubing junction. On (b)(6) /2015 customer reports surgeon was performing a balloon sinuplasty to decrease size of the turbinates. Instrument broke in half and scratched the patients lip, no other harm done, no treatment necessary.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2015-00113 |
| MDR Report Key | 5212039 |
| Report Source | USER FACILITY |
| Date Received | 2015-11-09 |
| Date of Report | 2015-10-23 |
| Date Mfgr Received | 2015-10-23 |
| Date Added to Maude | 2015-11-09 |
| 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 | USER SANDRA LEE |
| Manufacturer Street | 311 ENTERPRISE DRIVE |
| Manufacturer City | PLAINSBORO NJ 08536 |
| Manufacturer Country | US |
| Manufacturer Postal | 08536 |
| Manufacturer Phone | 6099362393 |
| Manufacturer G1 | INTEGRA YORK, PA INC. |
| Manufacturer Street | 589 DAVIES DRIVE |
| Manufacturer City | YORK PA 17402 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 17402 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | ELEVATOR 3714383 GORNEY SUCTION 3MM TIP |
| Generic Name | PFM11 |
| Product Code | KAD |
| Date Received | 2015-11-09 |
| Catalog Number | 3714383 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | * |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA YORK, PA INC. |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2015-11-09 |