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

Model Number 7210165-

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

Patient Problems Tissue Damage (2104); Blood Loss (2597); No Code Available (3191)

Event Date 07/24/2017

Event Type  Injury  

Manufacturer Narrative

A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter: occurred during a post-hysteroscopic myoma resection procedure.The surgeon removed the scope and was going to ablate the endometrial lining via hydrothermal ablation.The surgeon observed excessive bleeding expelling from the patient's cervix.Multiple sponge sticks were used without effect.The surgeon inserted a foley catheter and distended balloon with 30 ml sterile water.The bleeding gradually slowed.The surgeon then decided to perform a hysterectomy on the patient.The patient's medical history is submucosal fibroid and previous pregnancies.Patient is alive and well.

Manufacturer Narrative

Concomitant medical products: model#: 7210165, catalog#: 7210165, serial# (b)(4).If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, as per the additional information received ,there was 100cc of blood loss.Surgical time was extended by more than 30 minutes due to the product problem.

• Brand Name: TRUCLEAR
• 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 avenue; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6811428
• MDR Text Key: 83269885
• Report Number: 1643264-2017-21076
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• 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
• Report Date: 08/22/2017

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: 7210165-
• Device Catalogue Number: 7210165-
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/24/2017
• Initial Date FDA Received: 08/22/2017
• Supplement Dates Manufacturer Received: 08/22/2017
• Supplement Dates FDA Received: 09/20/2017
• 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): Required Intervention