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 Type  malfunction  

Manufacturer Narrative

The sample has been received and in-house evaluation is in progress.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 during surgery, on multiple occasions, the curved laser probe stuck when inserting inside the trocar.The probe was switched out on each case to complete surgery.There was no patient harm.

Manufacturer Narrative

Additional information provided.Two 25 gauge illuminated flex curved laser probe were received.A visual assessment of the first sample revealed no nonconformity.A visual assessment of the second sample revealed adhesive on the cannula tip.Each 25 gauge illuminated flex curved laser probe was inserted into a 25g trocar.The first sample had no resistance when inserted into the 25g trocar.The second sample became stuck when inserted through the 25g trocar, confirming the reported event.Additionally, the samples cannula outer diameters (od) were measured.With an od min/max values of 0.0200 to 0.0205 inches, the first sample¿s od was measured to be 0.02030 to 0.02035, meeting specifications.The second sample¿s od was measured to be 0.02030-0.02020, also not meeting specifications.Based on qa assessment, both products met specifications at the time of release.The root cause of the reported event can be attributed to excess adhesive residue on the laser probe tip during manufacturing.An internal investigation has been opened.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
• Manufacturer (Section G): ALCON RESEARCH, LTD. - IRVINE TECHNOLOGY CENTER; 15800 alton parkway; irvine CA 92618
• Manufacturer Contact: bryan blake ; 6201 south freeway; mail stop ab2-6; fort worth, TX 76134 ; 8176152230
• MDR Report Key: 7450391
• MDR Text Key: 106386449
• Report Number: 2028159-2018-00822
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K946135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/23/2018
• 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: 02/05/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/09/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/11/2017
• 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