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

Model Number 72202720

Device Problems Suction Problem (2170); Material Perforation (2205)

Patient Problems Perforation (2001); Tissue Damage (2104); No Code Available (3191)

Event Date 02/13/2017

Event Type  Injury  

Event Description

According to the reporter: the device was being used to monitor fluid deficit.Fluid quickly increased during case.At the end of the case, the deficit was 2610 cc's.Additional details regarding what happened to the products, lasix administered.The other device was being used for hysteroscopy.The surgeon viewed the perforation with the scope.There was a perforation of the patient's tissue.Lasix administered.The patient medical history is cervical stenosis, previous c-sections.The patient status is alive, no injury.

Manufacturer Narrative

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

• Brand Name: HYSTEROSCOPE
• 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: sharon murphy ; 60 middletown ave; north haven, CT 06473 ; 2034925267
• MDR Report Key: 6446909
• MDR Text Key: 71286461
• Report Number: 1643264-2017-21005
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K112134
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,user faci
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 03/01/2017

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 Model Number: 72202720
• Device Catalogue Number: 72202720
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/01/2017
• Initial Date FDA Received: 03/30/2017
• Supplement Dates Manufacturer Received: 03/01/2017
• Supplement Dates FDA Received: 10/02/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 48 YR