MAUDE Adverse Event Report: BEAVER-VISITEC INTERNATIONAL, LTD CATARACT BLADE; KNIFE, OPHTHALMIC

Model Number 375100

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 10/15/2020

Event Type  malfunction  

Event Description

During a percutaneous achilles tenotomy for unilateral clubfoot the cataract blade broke (blade reference #375100, lot#3194088) at the base, but not where it was directly tightened to the handle.The provider removed the severed piece that remained within the incision and confirmed all hardware was removed.Manufacturer response for bvi cataract blade, (brand not provided) (per site reporter).Cast technician reported that the manufacturer is being contacted and whole box of supply will be returned.

• Brand Name: CATARACT BLADE
• Type of Device: KNIFE, OPHTHALMIC
• Manufacturer (Section D): BEAVER-VISITEC INTERNATIONAL, LTD; 500 totten pond rd - 10 citypoint; waltham MA 02451
• MDR Report Key: 11087088
• MDR Text Key: 224082031
• Report Number: 11087088
• Device Sequence Number: 1
• Product Code: HNN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 11/20/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 375100
• Device Lot Number: 3194088
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 11/20/2020
• Event Location: Outpatient Treatment Facility
• Date Report to Manufacturer: 12/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 60 DA