MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-25 for MILTEX LASER COATED SPECULUM manufactured by Miltex / Integra.
[74145548]
Pt underwent an exam under anesthesia, loop electrosurgical excision procedure for severe cervical dysplasia. Although the laser coated speculum was inspected prior to use, it was not noted that in the area where the suction tube attaches to the phalange of the speculum that there was separation from the phalange and the laser coating had flaked away. At the end of procedure, staff noted the pt 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 reports, pt was properly grounded. We are seeking to make the mfr aware of this potential coating breakdown as it is in a difficult place to see if you're not expecting to find it. Leep procedure 2/2 sever cervical dysplasia. Is the product compounded: no. Is the product over-the-counter: no.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | MW5069412 |
| MDR Report Key | 6529802 |
| Date Received | 2017-04-25 |
| Date of Report | 2017-04-25 |
| Date of Event | 2017-04-11 |
| Date Added to Maude | 2017-04-28 |
| Event Key | 0 |
| Report Source Code | Voluntary report |
| Manufacturer Link | N |
| 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 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 0 |
| Brand Name | MILTEX LASER COATED SPECULUM |
| Generic Name | LASER COATED SPECULUM |
| Product Code | HDG |
| Date Received | 2017-04-25 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | N |
| Device Eval'ed by Mfgr | I |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | MILTEX / INTEGRA |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2017-04-25 |