MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, LTD MALOSA KIT; NEWMEDICA PHACO INSTRUMENT WITH CAPHEX

Catalog Number MMK928

Device Problem Material Fragmentation (1261)

Patient Problem Insufficient Information (4580)

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

Customer reported the end of the phaco chopper / mushroom manipulator broke off inside a patient's eye and safely removed.The mushroom/chopper is item number mmsu1221 and is a component of the malosa kit, ref: mmk928, newmedica phaco instrument with capsulorhexis.While the event was specific to a surgical kit distributed in the (b)(4), this mushroom/chopper is also a component in surgical kits distributed in the usa.

Event Description

Phaco chopper / mushroom manipulator component of the maloso kit, newmedica phaco instrument with caphex, broke off inside a patient's eye.It was the chopper end that broke off and was removed safely.

• Brand Name: MALOSA KIT
• Type of Device: NEWMEDICA PHACO INSTRUMENT WITH CAPHEX
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, LTD; waterloo industrial estate; bidford on avon, warwickshire B50 4 JH; UK B50 4JH
• MDR Report Key: 11847585
• MDR Text Key: 270784524
• Report Number: 3002808441-2021-00001
• Device Sequence Number: 1
• Product Code: HNQ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Type of Report: Initial
• Report Date: 05/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: MMK928
• Device Lot Number: 3359605
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/19/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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