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

Model Number 72203012

Device Problems Break (1069); Difficult to Remove (1528)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/19/2018

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 myomectomy, the blade jammed, broke and was stuck inside the patient.The surgical time extended 30 minutes or more due to the product problem.There was no patient injury.

Manufacturer Narrative

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

Manufacturer Narrative

Evaluation summary: one device was received for evaluation.This device had been used in the treatment or diagnosis of a patient.A review of the lot number reported indicates that the product was within the assigned expiration date at the time of the reported incident.The returned product did not meet specification as received.Visual inspection found the blade was damaged.The blade curled out of the tube.The reported condition was confirmed.The investigation found the blade was damaged and curled outside of the tube.The blade did not move freely when activated in the forward/reverse mode.The investigation identified the root cause of the reported event to be user error.If information is provided in the future, a supplemental report will be issued.

• Brand Name: TRUCLEAR ULTRA PLUS
• 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: 7328502
• MDR Text Key: 102076333
• Report Number: 1643264-2018-02027
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130215
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 04/23/2018

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 Expiration Date: 06/05/2022
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/30/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 02/20/2018
• Initial Date FDA Received: 03/09/2018
• Supplement Dates Manufacturer Received: 02/20/2018; 04/11/2018
• Supplement Dates FDA Received: 04/11/2018; 04/23/2018
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1