MAUDE Adverse Event Report: SYNERGETICS VERSAVIT; PHACOEMULSIFICATION CUTTER 25GA

Model Number 70025S

Device Problem Break (1069)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/22/2017

Event Type  malfunction  

Manufacturer Narrative

Cutter was returned in condition as described in the complaint.The end cap of the cutter became removed from the cutter during use.The end cap was returned in a separate pouch.No physical testing of performance was performed on the cutter, visual inspection only.Tube line set was cut off and needle had slight bend.Replacement cutter was also returned and a bend was noted in that cutter needle as well.Reviewed work order history for kit and no anomalies were noted.

Event Description

During procedure tip of the cutter broke off in the patient's eye.The doctor was able to retrieve the tip.Another cutter was used to complete the procedure.There was no patient injury reported.

Manufacturer Narrative

Correct spelling in manufactures address.Cutter was returned in condition as described in the complaint.The end cap of the cutter became removed from the cutter during use.The end cap was returned in a separate pouch.No physical testing of the performance was performed on the cutter, visual inspection only.The tube line set was cut off and the needle had a slight bend.A replacement cutter was also returned and a bend was noted in the cutter needle.Work order history was reviewed for the kit and no anomalies were noted.

Manufacturer Narrative

Vendor evaluation complete.Reviewed the cutter failure and noted that the weld failed on the end of the cutter causing the cap to come out of the end of the needle.It was noted that this was an isolated incident, the first in three years.Employee training was provided.

• Brand Name: VERSAVIT
• Type of Device: PHACOEMULSIFICATION CUTTER 25GA
• Manufacturer (Section D): SYNERGETICS; 3846 corporate center dr; o''fallon MO 63368
• Manufacturer (Section G): SYNERGETICS; 3845 corporate center dr.; o''fallon MO 63368
• Manufacturer Contact: sharon spencer ; 50 technology drive west; irvine, CA 92618 ; 949398-569
• MDR Report Key: 6417255
• MDR Text Key: 70548156
• Report Number: 0001932402-2017-00002
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K121675
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 02/23/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/20/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 10/24/2019
• Device Model Number: 70025S
• Device Lot Number: M0004450
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/14/2017
• 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