MAUDE Adverse Event Report: ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER LASER PROBES; INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED

Catalog Number 8065751593

Device Problem Sticking (1597)

Patient Problem No Consequences Or Impact To Patient (2199)

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 laser probes get stuck in the valved trocar during surgical procedures.There was no patient harm.

Manufacturer Narrative

Additional information is provided.The customer reported that several of the 25 gauge illuminated flex curved laser probes got stuck in the trocar.Another probe was used to complete the surgery.There was no patient impact.The 25 gauge illuminated flex curved laser probe pak was received.However, inside the 25 gauge illuminated flex curved laser probe pak, there was observed to be a 23 gauge illuminated flex curved laser probe tip.Therefore, the returned sample is not related to the reported event and functional testing was not conducted.The 25 gauge illuminated flex curved laser probe was manufactured on july 11, 2017.There were 930 paks associated with this lot.Based on qa assessment, the product met specifications at the time of release.A returned laser probe was received; however, it was found to be a different product than the reported event and was not tested.The reported event was unable to be confirmed.The root cause cannot be determined conclusively.The manufacturer internal reference number is: (b)(4).

• Brand Name: LASER PROBES
• Type of Device: INSTRUMENT, VITREOUS ASPIRATION AND CUTTING, AC-POWERED
• Manufacturer (Section D): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• MDR Report Key: 7430081
• MDR Text Key: 105534732
• Report Number: 2028159-2018-00753
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• PMA/PMN Number: K946135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other
• Type of Report: Initial,Followup
• Report Date: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/13/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2019
• Device Catalogue Number: 8065751593
• Device Lot Number: 17025690X
• Other Device ID Number: 380657515936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other