MAUDE Adverse Event Report: MEDITRINA INC. AVETA PEARL DISPOSABLE HYSTEROSCOPE; HYSTEROSCOPE (AND ACCESSORIES)

Model Number 214-228

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

Patient Problem Uterine Perforation (2121)

Event Date 02/28/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, the physician had trouble placing uterine manipulator for laparoscopic portion of case.Stenotic cervix was noted.Post laparoscopic procedure, dilation of cervix was completed for hysteroscopy.The physician introduced the aveta pearl scope.Cervix was difficult to navigate, and physician noted possible false passage.Physician noted the presence of scaring similar to ablation, but no ablation noted in chart.The scope was removed.After attempt to further dilate the cervix, pearl scope was inserted a second time and perforation was noted.Physician removed scope, took biopsy of cervix, and returned to laparoscopic access.Perforation was noted at posterior fundus and bleeding was addressed with cauterization.Additional information added: physician stated that aveta device did not malfunction.Perforation was caused by navigating a false passage created by uterine manipulator.Aveta system performed as intended.

Manufacturer Narrative

No device malfunction was reported during the procedure.Additional information provided by the physician stated that the aveta device did not malfunction.Perforation was caused by navigating a false passage created by uterine manipulator.Aveta system performed as intended.Lot history records were reviewed and devices met all applicable specifications at the time of release.The product was not returned for investigation.

• Brand Name: AVETA PEARL DISPOSABLE HYSTEROSCOPE
• Type of Device: HYSTEROSCOPE (AND ACCESSORIES)
• Manufacturer (Section D): MEDITRINA INC.; 1190 saratoga ave; suite 180; san jose CA 95129
• Manufacturer (Section G): MEDITRINA INC; 1190 saratoga ave; suite 180; san jose CA 95129
• Manufacturer Contact: lyudmila kokish ; 1190 saratoga ave; suite 180; san jose 95129 ; 4085192692
• MDR Report Key: 16452052
• MDR Text Key: 310332715
• Report Number: 3015512350-2021-00003
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190372
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/28/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 214-228
• Device Catalogue Number: 214-228
• Device Lot Number: M21J16-03
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/28/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/20/2021
• 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
• Patient Outcome(s): Required Intervention
• Patient Sex: Female