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

Event Description

A customer reported that the laser probes were getting stuck in the trocars.

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.

Manufacturer Narrative

Two 25 g probes were received for evaluation.Probe two were manufactured on december 20, 2017.There were 1284 paks associated with this lot.The laser probes were manufactured on december 4 and december 5 of 2017, respectively.There were 95 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 no obvious nonconformities.The laser probes were inserted into a 25ga trocar cannula and passed through with no noticeable resistance.The samples¿ outer cannula diameters were measured per drawing 460-1254-004, rev.P0.With an outer diameter min/max values of 0.0200 to 0.0205 inches, the two samples¿ outer diameter were measured to be 0.0202-0.0203 and 0.02015-0.0203 inches, both meeting specifications.The samples were found to meet specifications; therefore, the root cause of the reported event 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: 7440373
• MDR Text Key: 106012061
• Report Number: 2028159-2018-00789
• 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: 11/30/2019
• Device Catalogue Number: 8065751593
• Device Lot Number: 17038654X
• 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