MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2015-09-09 for ELEVATOR 3714383 GORNEY SUCTION 3MM TIP manufactured by Integra York, Pa Inc..
[25914483]
To date the device involved in the reported incident has not been received for evaluation. An investigation has been initiated based on the reported information.
Patient Sequence No: 1, Text Type: N, H10
[25914484]
During endoscopic sinus surgery the part broke in patients nose. There was no harm to the patient and the parts were retrieved.
Patient Sequence No: 1, Text Type: D, B5
[32666271]
On 10/7/2015 integra investigation completed. Device history evaluation. Failure analysis: there was a gorney suction elevator returned; not showing any unusual markings. The suction elevator returned in used condition showing wear. Evaluation of the suction elevator shows that the shaft/tube is broken off at before the bulb. The complaint report is confirmed. Device history evaluation : dhr complete with all available history. Nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: none. Corrective action preventive action history: none. Health hazard evaluation history: none. Conclusion: the root cause has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
| Report Number | 2523190-2015-00073 |
| MDR Report Key | 5063710 |
| Date Received | 2015-09-09 |
| Date of Report | 2015-08-19 |
| Date of Event | 2015-08-19 |
| Date Mfgr Received | 2015-10-07 |
| Date Added to Maude | 2015-09-09 |
| 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 | 2015-09-09 |
| Returned To Mfg | 2015-08-20 |
| Catalog Number | 3714383 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | R |
| Device Age | DA |
| Device Eval'ed by Mfgr | Y |
| 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 | 2015-09-09 |