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

Model Number 7210164S

Device Problem Incorrect Measurement (1383)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/27/2019

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 hysteroscopy, the device had a fluid deficit wherein it was measuring a negative number on the scale.It started at -300 then to -500, and then stopped at -999.The circulating nurse did a manual count of fluid deficit and was fine.There was no fluid deficit.There was no patient injury.

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.The returned sample did not meet specification as received.The visual inspection found the bag deflector damaged and there were several scratches on the design foil and display housing.The reported condition was confirmed.The investigation found the mai pole on the scale is very loose and the root cause of the failure.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 av; oklahoma OK 73107
• Manufacturer (Section G): MITG - OKLAHOMA CITY; 75 s. meridian av; oklahoma OK 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 9216411
• MDR Text Key: 163210297
• Report Number: 1643264-2019-20024
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K031616
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 7210164S
• Device Catalogue Number: 7210164S
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2019
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/22/2019
• 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