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

Model Number 214-251

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

Patient Problem Uterine Perforation (2121)

Event Date 03/16/2023

Event Type  Injury  

Manufacturer Narrative

Based on the review of the complaint, no device malfunction occured.The device performed as intended.Doctor looked laparoscopically to confirm no adverse effects to the patient, specifically no issues to the bowel.Doctor followed up with patient to confirm no adverse effects.

Event Description

On (b)(6) 2023, the doctor resected large polyp.After resecting it, blood was in cavity with no fluid loss and the doctor extended scope to fundus causing a minor perforation.Doctor looked laparoscopically to confirm no adverse effects to the patient, specifically no issues to the bowel.Doctor followed up with patient to confirm no adverse effects.

• 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 96129 ; 4085192692
• MDR Report Key: 16585475
• MDR Text Key: 311708644
• Report Number: 3015512350-2023-00005
• 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: 03/21/2023

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?: No
• Device Operator: Health Professional
• Device Model Number: 214-251
• Device Catalogue Number: 214-251
• Device Lot Number: M22J15-03
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/16/2023
• Initial Date FDA Received: 03/21/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/24/2022
• 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 Outcome(s): Required Intervention
• Patient Sex: Female