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

Model Number 7209208-

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 09/29/2017

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

According to the reporter, during a gynecological procedure, when a device was advanced into the uterine cavity through the scope, black plastic material was pushed out of the working channel into the cavity.The black material was removed with graspers and then the procedure was finished successfully.There was no patient injury.

Manufacturer Narrative

Evaluation summary: the product sample was not returned to the post market vigilance (pmv) laboratory; however, a picture was provided by the customer for analysis.This device has been used in the treatment or diagnosis of a patient.The sample did not meet specification.The picture sample showed black plastic was broken in pieces.The reported condition was confirmed.The investigation could not determine a root cause or a probable root cause for the customer's report based on the information provided.If information is provided in the future, a supplemental report will be issued.

Manufacturer Narrative

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

• Brand Name: TRUCLEAR OPERATIVE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridianave; oklahoma OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder,co, CT 80301 ; 2034925563
• MDR Report Key: 6976024
• MDR Text Key: 90769485
• Report Number: 1643264-2017-21123
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K013870
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 05/25/2018

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
• Device Model Number: 7209208-
• Device Catalogue Number: 7209208-
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/29/2017
• Initial Date FDA Received: 10/25/2017
• Supplement Dates Manufacturer Received: 04/23/2018; 04/23/2018
• Supplement Dates FDA Received: 05/01/2018; 05/25/2018
• Was Device Evaluated by Manufacturer?: Yes
• 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 Age: 47 YR