MAUDE Adverse Event Report: MANI, INC. MANI TROCAR KIT; OPHTHALMIC TROCAR/CANNULA

Model Number MTK23S

Device Problem Material Fragmentation (1261)

Patient Problem Uveitis (2122)

Event Type  Injury  

Manufacturer Narrative

An assistant of the surgeon informed the distributor with regard to the occurrence of the adverse event, but the assistant did not disclose further details of the incident.The distributor asked more information to the surgeon and the assistant, but they did not reply.

Event Description

A distributor in (b)(4) reported to us that the metal part of the cannula of the device broke in patient's eye when a surgeon tried to remove 3 valved cannulas placed on the eye after an eye surgery had finished.The surgeon decided not to try to take the metal part out of the patient's eye on the same day because the eye was inflamed and the anesthesia was wearing off.The surgeon managed to take the metal part out of the eye on the next day.

• Brand Name: MANI TROCAR KIT
• Type of Device: OPHTHALMIC TROCAR/CANNULA
• Manufacturer (Section D): MANI, INC.; 8-3 kiyohara indusrial park; utsunomiya, tochigi 321-3 231; JA 321-3231
• Manufacturer Contact: hiroyuki ogiwara ; 8-3 kiyohara industrial park; utsunomiya, tochigi 321-3-231 ; JA 321-3231
• MDR Report Key: 10857966
• MDR Text Key: 216841573
• Report Number: 3002692886-2020-00003
• Device Sequence Number: 1
• Product Code: NGY
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 11/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2021
• Device Model Number: MTK23S
• Device Catalogue Number: MTK23S
• Device Lot Number: V190039500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/28/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/26/2019
• 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