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 Known Impact Or Consequence To Patient (2692)

Event Date 03/20/2018

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 were getting stuck in the trocars.

Manufacturer Narrative

Additional information is provided.Three 25ga probes were received for evaluation and were manufactured on january 3, 2018.There were 1470 paks associated with this lot.The laser probes were manufactured on december 5, december 7, and december 7 of 2017, respectively.There were 96 probes associated with each lot.Based on qa assessment, the product met specifications at the time of release.A visual assessment of the returned samples showed excess adhesive on the tip near the cannula-nitinol junction for the first two samples.Those two laser probes were inserted into a 25ga trocar cannula, but resistance can be felt near the junction of the cannula and the nitinol tip, confirming the customer reported event.The third laser probe had an attached note indicating that it is an example of a good laser probe.Visual evaluation showed no obvious nonconformities and the trocar was able to fit smoothly.The root cause of the reported event can be attributed to excess adhesive residue on the laser probe cannula tip.The manufacturer internal reference number is: (b)(4).

Manufacturer Narrative

Additional information is provided.The manufacturer internal reference number is: (b)(4).

Event Description

A customer reported that the laser probe was getting stuck in the trocars.Additional information reports that the product was exchanged to complete the procedure with no harm to the patient.

• 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: 7440390
• MDR Text Key: 105915413
• Report Number: 2028159-2018-00788
• 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: other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/09/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2019
• Device Catalogue Number: 8065751593
• Device Lot Number: 18010005X
• Other Device ID Number: 380657515936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2018
• Date Manufacturer Received: 06/15/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other