MAUDE Adverse Event Report: MILTEX / INTEGRA MILTEX LASER COATED SPECULUM

Device Problems Material Disintegration (1177); Material Separation (1562)

Patient Problem Superficial (First Degree) Burn (2685)

Event Date 04/11/2017

Event Type  malfunction  

Event Description

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.

• Brand Name: MILTEX LASER COATED SPECULUM
• Type of Device: LASER COATED SPECULUM
• Manufacturer (Section D): MILTEX / INTEGRA
• MDR Report Key: 6529802
• MDR Text Key: 74145548
• Report Number: MW5069412
• Device Sequence Number: 1
• Product Code: HDG
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 04/25/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/25/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 36 YR
• Patient Weight: 67