MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, LTD MALOSA; SINSKEY HOOK

Catalog Number 581442

Device Problem Material Fragmentation (1261)

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

Event Date 06/29/2021

Event Type  malfunction  

Event Description

Customer contacted the sales rep to inform they encountered an issue where a sinskey hook broke during a surgery; the surgeon had to suck it up with the phaco without causing any damaged to the patient.

• Brand Name: MALOSA
• Type of Device: SINSKEY HOOK
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, LTD; waterloo industrial estate; bidford on avon, warwickshire B50 4 JH; UK B50 4JH
• MDR Report Key: 12307478
• MDR Text Key: 266024839
• Report Number: 3002808441-2021-00004
• 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,u
• Type of Report: Initial
• Report Date: 08/09/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/24/2024
• Device Catalogue Number: 581442
• Device Lot Number: 3367376
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 06/30/2021
• 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