MAUDE Adverse Event Report: MITG - OKLAHOMA CITY TRUCLEAR 5.0 OP HYSTERSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 72202976-

Device Problems Material Opacification (1426); Temperature Problem (3022)

Patient Problems Burn(s) (1757); Injury (2348)

Event Date 02/06/2017

Event Type  Injury  

Event Description

According to the reporter; the patient reported a labial burn after the use of the device for a hysteroscopy.The doctor believes the device is the only likely device to have caused such a condition as it was the only device with an electrical source, in particular the light source of the scope and was used within the reported anatomical region.The device also produced a weird image during use.

Manufacturer Narrative

If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR 5.0 OP HYSTERSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer (Section G): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma city OK 73107
• Manufacturer Contact: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6388758
• MDR Text Key: 69402316
• Report Number: 1643264-2017-21001
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 02/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 72202976-
• Device Catalogue Number: 72202976-
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2017
• Initial Date FDA Received: 03/08/2017
• Supplement Dates Manufacturer Received: 02/07/2017
• Supplement Dates FDA Received: 09/29/2017
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other