MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - HOUSTON INFINITI SURGICAL PROCEDURE PAK; GENERAL SURGERY TRAY (KIT)

Catalog Number 8065752101

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 05/25/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation, including root cause analysis, is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.(b)(4).

Event Description

A customer reported that the ultrasound tip broke in the eye during an eye surgery.The tip was removed from the patient's eye and collected.The product was replaced and the procedure was completed without harm to the patient.A product sample has been requested for evaluation.

Manufacturer Narrative

A phaco tip sample was returned for evaluation.The front section of the tip was received still in the infusion sleeve.No lot number was identified with this complaint; therefore, a lot history review could not be conducted.A visual inspection of the phaco tip received was performed and deemed nonconforming.The tip is broken at the transition between the cone and cannula.The break area is slightly jagged with part of one section of the wall pushed inward.The wall thickness at the break area is even.Wear is present on the threads and back of flange.The complaint does confirm the phaco tip is broken.The exact reason of how and when the phaco tip became broken cannot be determined from this evaluation.The most likely reason for tip breakage is from a machine parameter not appropriate for this tip, tuning without water flow, occluded tip, or an improper sleeve installation.(b)(4).

• Brand Name: INFINITI SURGICAL PROCEDURE PAK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer (Section G): ALCON RESEARCH, LTD. - HOUSTON; 9965 buffalo speedway; houston TX 77054
• Manufacturer Contact: eddie darton, md, jd ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8175686660
• MDR Report Key: 5727190
• MDR Text Key: 48445578
• Report Number: 1644019-2016-00924
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K880961
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 08/30/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752101
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/07/2016
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 05/24/2016
• Initial Date FDA Received: 06/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/30/2016
• Was Device Evaluated by Manufacturer?: Yes
• 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