MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-07-26 for LEEP COATED VAGINAL SPECULUM XXX-LEEP manufactured by Integra York, Pa Inc..
[81249043]
On 7/21/2017 integra investigation completed. Method: failure analysis, device history evaluation. Results: failure analysis. Failure analysis cannot be completed due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation. Unconfirmed/no return of device for evaluation. Device history evaluation - dhr review could not be completed, due to product id unidentified. Conclusion: root cause cannot be determined due to the lack of information received to perform a complete investigation. Product has not been returned for evaluation.
Patient Sequence No: 1, Text Type: N, H10
[81249044]
Fda mw5069412 reports a patient underwent an exam under anesthesia. Leep electrosurgical excision procedure for severe cervical dysplasia. Although the laser coated speculum was inspected before use it was not noted that in the area where the suction attaches to the phalange of the speculum that there was a separation from the phalange and the laser coating had flaked away. At the end of the procedure staff noted the patient sustained 2 superficial vaginal burns (at 3 o'clock and 9 o'clock) which align with where the coating had been compromised. This procedure was done with monopolar cautery. Per operating room staff, patient was properly grounded. The potential coating breakdown is in a difficult place to see if you are not expecting to find it. On (b)(6)2017 customer reports no further information available.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2523190-2017-00084 |
| MDR Report Key | 6743917 |
| Date Received | 2017-07-26 |
| Date of Report | 2017-06-29 |
| Date of Event | 2017-04-11 |
| Date Mfgr Received | 2017-06-29 |
| Date Added to Maude | 2017-07-26 |
| 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 | 0 |
| Brand Name | LEEP COATED VAGINAL SPECULUM |
| Generic Name | M7-OB-GYN |
| Product Code | HDL |
| Date Received | 2017-07-26 |
| Catalog Number | XXX-LEEP |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | R |
| 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 | 2017-07-26 |