MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2017-05-23 for LEEP GRAVES W/EVAC LARGE G92-005 31-201 manufactured by Integra - Miltex.
[75815974]
On 5/19/2017 integra investigation completed. Manufacture date unknown. Method: failure analysis. Device history evaluation results: failure analysis: - the instrument wasn't returned because the medical center must hold onto it for 1 year. This investigation will be completed on the pictures that were supplied to us. Reviewed the pictures and we can confirm that there is damage to the instrument, there appears to be corrosion and breakage in the leep coating that should be completely coated. This happens when there is a breakage in the coating and with continued use and cleaning it causes corrosion under the coating causing it to lift and break. There isn't any identification markings in the pictures supplied to us, without this information we cannot confirm that this is our instrument. This instrument has been discontinued that last known activity was 2011. Device history evaluation - nonconforming product report / nonconforming material report history: none. Variance authorization / deviation history: none. Engineering change order/manufacturing change order history: there is no applicable engineering change order/manufacturing change order history. Corrective action preventive action history/corrections: none. Health hazard evaluation history: none. Conclusion: this investigation was completed with pictures that were supplied by the medical center. We can see there is damage to the leep coating on the instrument. The complaint report has been confirmed; the root cause of damage has not been identified as a workmanship or material deficiency.
Patient Sequence No: 1, Text Type: N, H10
[75815975]
Customer initially reports the device was used for a leep procedure on patient with severe cervical dysplasia. Afterwards doctor found 2 superficial burns in vagina at 9 & 3 o'clock. Doctor noted no follow-up necessary. The nurse re-examined the device (product 31-201) afterwards and found the 2 areas where the insulation material had flaked off.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00057 |
| MDR Report Key | 6586099 |
| Report Source | USER FACILITY |
| Date Received | 2017-05-23 |
| Date of Report | 2017-04-26 |
| Date Mfgr Received | 2017-04-26 |
| Date Added to Maude | 2017-05-23 |
| 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 | 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 - MILTEX |
| 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 | LEEP GRAVES W/EVAC LARGE G92-005 |
| Generic Name | M7 - OB-GYN |
| Product Code | HDF |
| Date Received | 2017-05-23 |
| Catalog Number | 31-201 |
| Lot Number | UNKNOWN |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | INTEGRA - MILTEX |
| Manufacturer Address | 589 DAVIES DRIVE 589 DAVIES DRIVE YORK PA 17402 US 17402 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 1. Other | 2017-05-23 |