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

Model Number UNKNOWN TRUCLEAR DEVICE

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Fever (1858); Perforation (2001)

Event Type  Injury  

Manufacturer Narrative

Title: an alternative approach for removal of placental remnants: hysteroscopic morcellation source: journal of minimally invasive gynecology, vol.20, article no.6, (796-802),(november/december 2013, date of publication: 24-apr-2013.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, during hysteroscopic morcellation was used for removal of placental remains.Analysis of 105 procedures was performed.Perforation (access related) 4 (3.8%), fever 3 (2.9%), perforation, hysteroscopy related 2 (1.9%), incomplete removal (fluid deficit greater than or equal to 2500 ml) 2 (1.9%), incomplete removal at follow up 2 (1.9%), hemorrhage 1 (1%) and abdominal pain 1 (1%).

Manufacturer Narrative

Evaluation summary: this report is based on information provided by the post market vigilance (pmv) team.The product sample was not returned to the post market vigilance laboratory; however, a picture was provided by the customer for analysis.The information provided does not indicate if the device met specification.The reported condition was not confirmed due to inadequate sample.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.If additional information is obtained, or the sample is returned to investigation team, we will re-open this investigation.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer (Section G): MITG - OKLAHOMA CITY; 75 s. meridian ave; oklahoma OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7834202
• MDR Text Key: 118806052
• Report Number: 1643264-2018-02059
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: BE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2018

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: UNKNOWN TRUCLEAR DEVICE
• Device Catalogue Number: UNKNOWN TRUCLEAR DEVICE
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/13/2018
• Initial Date FDA Received: 08/30/2018
• Supplement Dates Manufacturer Received: 10/31/2018
• Supplement Dates FDA Received: 11/29/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Required Intervention