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

Model Number 72203012

Device Problems Break (1069); Detachment of Device or Device Component (2907)

Patient Problems Radiation Exposure, Unintended (3164); Device Embedded In Tissue or Plaque (3165)

Event Date 09/04/2018

Event Type  Injury  

Manufacturer Narrative

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

Event Description

According to the reporter, during myomectomy, the blade piston was broken due to excessive torqueing on the handpiece.The piston cracked and some of the broken metal remained in the patient.The surgical time was extended by 30 minutes or more due to the product problem.They opened a new one and the patient needed to be x rayed following the procedure to see if any metal was left.They took the blade to complete the case.

Manufacturer Narrative

Evaluation summary: three devices were received for evaluation.The returned product did not meet specification as received.Visual inspection found the blade was damaged on one of the devices.The blade curled out of the tube.The other two devices had no visual defects.The reported condition was confirmed.The investigation found the blade was damaged and curled outside of the tube on one of the devices.The blade did not move freely when activated in the forward/reverse mode.The other two devices worked normally.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
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MITG-OKLAHOMA CITY; 75 s. meridian ave.; oklahoma,ok 73107 ; CT 73107
• Manufacturer (Section G): MITG-OKLAHOMA CITY; 75 s. meridian ave.; oklahoma,ok 73107 ; CT 73107
• Manufacturer Contact: lisa hernandez ; 5920 longbow drive; boulder, CO 80301 ; 2034925563
• MDR Report Key: 7911782
• MDR Text Key: 121802115
• Report Number: 1643264-2018-02065
• Device Sequence Number: 1
• Product Code: HIH
• UDI-Device Identifier: 90884521744116
• UDI-Public: 90884521744116
• 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: company representative,health
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/20/2018

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 Expiration Date: 03/02/2021
• Device Model Number: 72203012
• Device Catalogue Number: 72203012
• Device Lot Number: 4173624
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/18/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/04/2018
• Initial Date FDA Received: 09/26/2018
• Supplement Dates Manufacturer Received: 10/29/2018
• Supplement Dates FDA Received: 11/20/2018
• 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 Outcome(s): Required Intervention