MAUDE Adverse Event Report: MEDITRINA INC. AVETA CORAL DISPOSABLE HYSTEROSCOPE

Model Number 214-251

Device Problems Mechanical Problem (1384); Improper or Incorrect Procedure or Method (2017)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/23/2023

Event Type  malfunction  

Manufacturer Narrative

Visual inspection of the returned complaint device confrmed that the tongue of the coral scope was dislodged from the scope.The root cause of scope tip (tongue) break is due to the flex drd resecting teeth was being operated too close to the working channel of the hysteroscope causing the silicone covering to rip off and cut through the tongue at the tip.The physician stated that they used graspers to remove the lose metal piece from the uterine cavity.All devices are 100% inspected prior to release for distribution.Lot history record for the coral scope was reviewed and devices met all applicable specifications at the time of release.The aveta system user manual- instructions for use, ifu-200-1202 rev p provides instruction for correct positioning of the resecting device during resection, "important: always visualize full cutting window before activating resection.Do not activate cutting tip unless cutting window is fully extended from hysteroscope working channel.".

Event Description

It was reported that the physician was operating the aveta flex disposable resecting device (flex drd) inside the aveta coral disposable hysteroscope (coral scope).The physician operated the flex drd resecting teeth too close to the working channel of the coral scope causing the silicone protective layer at the tip of the coral scope to rip off and dislodge the tongue of the scope.The tongue of the coral sope was left in cavity which was retrieved with graspers.

• Brand Name: AVETA CORAL DISPOSABLE HYSTEROSCOPE
• Type of Device: AVETA CORAL DISPOSABLE HYSTEROSCOPE
• 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, CA 95129 ; 4085192692
• MDR Report Key: 17372411
• MDR Text Key: 319620889
• Report Number: 3015512350-2023-00008
• Device Sequence Number: 1
• Product Code: HIH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213171
• 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: 07/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 214-251
• Device Catalogue Number: 214-251
• Device Lot Number: M22F17-03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/10/2023
• Date Manufacturer Received: 06/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/29/2022
• 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 Sex: Female