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.No further information was able to be obtained from this customer.However, a probe was returned for evaluation.The probe was packaged on (b)(6) 2017.There were (b)(4) paks associated with this lot.Based on qa assessment, the products met specifications at the time of release.25g probe was received for evaluation.A visual assessment of the returned sample revealed adhesive on the cannula tip and a significantly bent tip.The 25g probe was inserted into a 25ga trocar.The bent nitinol tip fell off.The laser probe cannula was then inserted into the 25ga trocar and no resistance was felt.Additionally, the sample¿s cannula outer diameter (od) was measured.With an od min/max values of 0.02000 to 0.02050 inches, the sample¿s cannula od was measured to be 0.02045 to 0.02050, meeting specifications.The reported event was unable to be confirmed.Therefore, the root cause could not 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
• 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: 7430077
• MDR Text Key: 105589849
• Report Number: 2028159-2018-00754
• 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: foreign,other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/20/2018

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: 05/31/2019
• Device Catalogue Number: 8065751593
• Device Lot Number: 17025339X
• Other Device ID Number: 380657515936
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/19/2018
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/05/2017
• 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