MAUDE Adverse Event Report: SYNERGETICS SYNERGETICS DIRECTIONAL LASER PROBE

Model Number 55.26.25

Device Problem Retraction Problem (1536)

Patient Problem Cataract (1766)

Event Date 02/01/2016

Event Type  malfunction  

Event Description

A retractable endo-photocoagulation probe failed to retract as the surgeon was removing from the sclerotomy and made contact with the patient's natural crystalline lens.Contact with the lens may led to faster cataract formation.

• Brand Name: SYNERGETICS DIRECTIONAL LASER PROBE
• Type of Device: LASER PROBE
• Manufacturer (Section D): SYNERGETICS; 3845 corporate centre drive; ofallon MO 63368
• Manufacturer (Section G): SYNERGETICS; 3845 corporate centre drive; ofallon MO 63368
• Manufacturer Contact: dan regan ; 3845 corporate centre drive; ofallon, MO 63368 ; 6367945013
• MDR Report Key: 5473181
• MDR Text Key: 39846676
• Report Number: 1932402-2016-00001
• Device Sequence Number: 1
• Product Code: GEX
• Combination Product (y/n): N
• PMA/PMN Number: K953407
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial
• Report Date: 03/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 11/30/2018
• Device Model Number: 55.26.25
• Device Catalogue Number: 55.26.25
• Device Lot Number: M556270
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/08/2016
• Date Manufacturer Received: 02/03/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/01/2015
• 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): Other
• Patient Age: 45 YR