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

Catalog Number 8065752555

Device Problems Detachment Of Device Component (1104); 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 the manufacturer internal reference number is: (b)(4).

Event Description

A surgeon reported that the laser probe was caught in the trocar cannula during surgery.The trocar cannula came off with the laser probe.The surgeon replaced the product to complete the surgery.There was no patient harm reported.

Manufacturer Narrative

Additional information is provided.No further information was able to be obtained from this customer.With no additional, related information provided, the customers reported event was not able to be confirmed.However, a probe was returned for evaluation.The probe was manufactured on august 29, 2017.There were 156 paks associated with this lot.Based on qa assessment, the product met specifications at the time of release.25ga probe was received for evaluation.A visual assessment of the returned sample was performed on (b)(6) 2018 and it was observed that the laser probe cannula and articulating tip were extremely bent and a 25ga trocar was in the middle of the tip.The trocar was removed without any resistance.However, due to the physical damage at the tip, functional testing could not be conducted.Additionally, the probe was returned without a pak or lot number provided, so the rfid tag was read to determine the laser probe lot number 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
• 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: 7610237
• MDR Text Key: 111837582
• Report Number: 2028159-2018-01260
• Device Sequence Number: 1
• Product Code: HQE
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K946135
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Home Health Aide
• Type of Report: Initial,Followup
• Report Date: 09/06/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/18/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 8065752555
• Device Lot Number: 17029235X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/12/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2018
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 08/29/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other