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

Model Number 72204753

Device Problems Break (1069); Device Difficult to Setup or Prepare (1487)

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

Event Date 08/30/2017

Event Type  malfunction  

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, pre- operatively, the scrub tech was trying to assemble the device, but the sheath did not fit over scope and was difficult to attach.They tried to attached the device, but the device was damaged were the sheaths would no longer fit.No patient involved.

Manufacturer Narrative

Based on review of the file, this report was updated from a malfunction to a non-reportable event.If information is provided in the future, a supplemental report will be issued.

Event Description

According to the reporter, pre- operatively, the scrub tech was trying to assemble the device, but the sheath did not fit over scope and was difficult to attach.They tried to attached the device, but the device was damaged were the sheaths would no longer fit.No patient involved.

• Brand Name: TRUCLEAR
• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6871662
• MDR Text Key: 86755622
• Report Number: 1643264-2017-21088
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K152143
• 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: 08/31/2017

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: 72204753
• Device Catalogue Number: 72204753
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 08/31/2017
• Initial Date FDA Received: 09/18/2017
• Supplement Dates Manufacturer Received: 08/31/2017
• Supplement Dates FDA Received: 09/29/2017
• 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